An Immunological Toolkit for Clinical Application

Lead Research Organisation: Newcastle University
Department Name: Institute of Cellular Medicine

Abstract

Patients with rheumatoid arthritis (RA) suffer with joint pain and stiffness, and joint damage which leads to a reduced ability to carry out everyday tasks. Although these are the most obvious features of the disease, the root cause of the disease lies within the human immune system. At the moment we don?t fully understand the immune abnormalities that lead to RA but, if we did, this should help us to manage the disease better. It would become easier to make a diagnosis, as well as to determine whether a patient?s RA is likely to damage their joints in the future. Perhaps most importantly it would help us to design better drugs to combat the disease, and to better use the drugs that already exist. Something that we would really like to be able to do is to decide the most appropriate drug for each patient and a better understanding of the immune abnormalities would also help here.
Therefore our plans are to study, in detail, the immune system of patients with RA. This will involve taking blood from patients and running a panel of advanced laboratory tests on their white blood cells. We will compare the results we obtain with the immune changes in healthy individuals responding to a vaccine ? expecting some to be the same and some to be different. Our work is in three phases and, during the phases, we plan to slowly ?home in? on simple laboratory tests that will allow us to measure what is happening to the immune system in patients with RA. An exciting aspect of the work is that what is relevant to RA may also relate to other diseases (diabetes, multiple sclerosis, asthma) and to patients with an organ transplant. Therefore our results could have wide-ranging influence beyond improving the care of patients with RA

Technical Summary

Current management of rheumatoid arthritis (RA) is based upon measurement of inflammation and tissue damage. However these are downstream consequences of immune dysregulation, and sub-optimal guides for managing patients and designing disease-modifying drugs. Our aim is to identify the key immune abnormalities that define RA and to develop an immunological toolkit: a set of functional and flow cytometry-based assays to study and monitor the dysfunctional immune system. A UK-wide collaboration of academic and industrial scientists will develop the toolkit, using regular discussions and workshops. Although current theory suggests that key immune abnormalities in RA should reside within T- or B- lymphocytes, lessons from other diseases suggest a discovery approach to be most appropriate, encompassing deep immunophenotyping of major peripheral blood immune and inflammatory cell subsets. Therefore in phase I purified CD4+ and CD8+ T-cells, B-cells, monocytes, NK cells and neutrophils will undergo: multiparameter flow cytometry for cell surface phenotype, intracellular cytokine and lineage transcription factor expression, and signalling pathways; transcriptional analysis using Affymetrix U219 microarrays; and small RNA sequencing. A well-defined subset (n=30) will subsequently undergo ultra-deep RNA sequencing, providing a complete picture of the RA transcriptome. We will study three sets of individuals: 30 healthy controls during an evolving vaccination response; 200 established RA patients, stratified for disease activity and disease duration; and 30 RA patients receiving abatacept (costimulation blockade). Hypothesis-generating phase I will provide a detailed signature of cells and pathways that characterise the RA immune system, and inform the design of customised, low-density array(s) (LDA), alongside the initial development of relevant in vitro immune function assays. In phase II these will be applied to 100 patients with recent onset inflammatory arthritis, sampled longitudinally, alongside a refined panel of flow cytometry protocols. Signals that are consistent between phases I and II will lead to further refinement of the in vitro assays ready for phase III, which encompasses proof-of-concept studies with novel therapeutic compounds, provided by industrial partners. Here the final immune toolkit will be ?road tested?, providing a secondary outcome measure that predicts conventional efficacy parameters. Success in this challenging programme will provide a novel portfolio of immune function assays, potentially applicable to RA but also other immunopathologies. Their widespread adoption and application across diseases will reinforce the successful image of UK translational immunological research. Intellectual property generated by the work will be protected for future exploitation as appropriate.

Organisations


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Filkova M (2016) Is there a role of synovial biopsy in drug development? in BMC musculoskeletal disorders


 
Description MRC Population and Systems Medicine Board
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
 
Description Model collaborative parterships with industry
Geographic Reach National 
Policy Influence Type Citation in other policy documents
 
Description NICE Meeting
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Newcastle Audit Meeting
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Oslo anti-TNF Tendering Meeting 2017
Geographic Reach Europe 
Policy Influence Type Gave evidence to a government review
Impact Tendering meeting to determine anti-TNF tariffs for the next two years. Keynote speaker.
 
Description Translational Research Collaboration for Joint & related inflammatory diseases- Steering Committee Meeting
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
URL http://www.nihr.ac.uk/life-sciences-industry/access-to-expertise-and-collaborations/collaborations-f...
 
Description Wellcome Trust 4WARD Meeting 2016 - Clinical PhD Funding - Newcastle, Leeds, Manchester, Sheffield
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
Impact Consortium Clinical PhD Funding Meeting
 
Description APIPPRA
Amount £66,120 (GBP)
Funding ID BH149466 
Organisation King's College London (KCL) 
Department School of Medicine KCL
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 03/2015 
End 02/2019
 
Description Abbvie Investigator initiated funding
Amount £109,465 (GBP)
Funding ID BH137913 
Organisation AbbVie 
Sector Private
Country Global
Start 12/2013 
End 09/2015
 
Description BRC Clinical Training Fellowship
Amount £60,000 (GBP)
Organisation National Institute for Health Research (NIHR) 
Department NIHR/BRC
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 10/2016 
End 09/2019
 
Description EU IMI2 (Rheuma Tolerance for Cure [RTCure]) - KCL
Amount € 465,000 (EUR)
Organisation European Commission (EC) 
Department Innovative Medicines Initiative (IMI)
Sector Multiple
Country European Union (EU)
Start 06/2017 
End 05/2022
 
Description EU IMI2 (Rheuma Tolerance for Cure [RTCure]) - Newcastle
Amount € 465,000 (EUR)
Organisation European Commission (EC) 
Department Innovative Medicines Initiative (IMI)
Sector Multiple
Country European Union (EU)
Start 06/2017 
End 05/2022
 
Description Immunogenicity of Biologic Therapies Pfizer
Amount £69,750 (GBP)
Funding ID BH149075 
Organisation Pfizer Ltd 
Sector Private
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 04/2014 
End 03/2016
 
Description MATURA
Amount £550,614 (GBP)
Funding ID BH137922 
Organisation MRC-UK 
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 03/2014 
End 03/2018
 
Description Proximity to Discovery
Amount £250,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 07/2015 
End 12/2016
 
Title The Immunological Toolkit 
Description This development of this suite of immune biomarkers - the toolkit - is the major objective of the RA-MAP Consortium. It will be developed from biological material derived at 3 monthly intervals from TACERA study participants. 
Type Of Material Biological samples 
Provided To Others? No  
Impact in progress 
 
Title Diversity analysis of flow cytometry data 
Description A novel method to measure diversity of immune cells in RA patients, which can be used to detect changes in the immune profiling over time and to categorise RA patients into a number of subgroups (eg remission / non-remission at 6 months) 
Type Of Material Data analysis technique 
Year Produced 2017 
Provided To Others? Yes  
Impact None yet. 
 
Title FEMERA: Functional Endotyping Model for Early RA 
Description Projection of multi-dimensional data onto two dimensions for consistency scoring and identification of TNF-reactive and Lymphocytic RA endotypes. 
Type Of Material Computer model/algorithm 
Year Produced 2017 
Provided To Others? Yes  
Impact Application of a method developed by SimOmics permitting identification of endotypes in RA and mapping them to a systems model of RA. 
 
Title MedSciNet EDC for TACERA study 
Description A study specific Electronic Data Capture (EDC) system has been designed for the TACRA study. This will be the electronic Case Record Form (eCRF) for the study as well as forming part of the Study Management system. The system will also automatically enrol patients once they have been deemed eligible. The EDC system is designed to follow the order of the study assessments and include all the clinical data (incl. Medication history, lifestyle factors questionnaire, DAS28 etc). 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact The clinical dataset will be archived after the TACERA study closure and data will be available to other researchers upon request. 
 
Title PRE-RA: Predictors of Remission in Early RA. 
Description A cross-platform multi-omics model of predictors of remission for stratification of early RA patients. 
Type Of Material Computer model/algorithm 
Year Produced 2017 
Provided To Others? Yes  
Impact In preparation. 
 
Title RA-MAP Predictors of Remission 2017 
Description We have amalgamated 19 datasets provided by the pharmaceutical industry into a single dataset. This required understanding and harmonisation of variables as well as re-anonymisation of the individual components of the dataset. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact The datasets will be provided to the MRC Biostatistics Unit at Cambridge. They are now working on identification of predictors of remission or a remission trajectory. Draft paper to be submitted Q2 2017. Second paper on transcriptomics data to be submitted Q2 2017. Multi-omics and additional papers in preparation for publication 2017-2018. 
 
Title TranSMART RA-MAP Multiomics database. 
Description The Innovative Medicines Initiative eTRIKS team have provided technical support to the RA-MAP informatics team (Mike Barnes lead) to assist in the deployment of an open source datamart (TranSMART) for the RA-MAP projects. The TranSMART provides a useful repository tool for important data (patient clinical data, transcriptomics, metabolomics etc) that are acquired from the RA-MAP projects. The RA-MAP TranSMART is now operational and enabling secure data sharing between consortium members. 
Type Of Material Database/Collection of data 
Year Produced 2014 
Provided To Others? Yes  
Impact The Barnes team have propagated the support provided for RA-MAP to enable the deployment of additional TranSMART datamarts for the MRC-PSORT and MRC-MATURA projects. This has created a unique, common datamarts infrastructure across three closely related MRC projects investigating immune-inflammatory disease, creating opportunities for future data integration ad integrated analysis for stratified medicine and drug discovery. [Updates from March 2016] We are sharing curated public data in the database with the MRC-MATURA, MRC-PSORT and IMI-etriks projects Knowledge sharing and troubleshooting between these projects has enabled more rapid data curation and data infrastructure development for the project. We have also provided advice and troubleshooting on TranSMART configuration to the MRC-CHART (Juvenile Idiopathic Arthritis) and MRC-Masterplan (SLE) consortia [Updates from March 2017] As a complex, highly curated dataset, the RA-Map TranSMART is serving as an exemplar for development of TranSMART for the the MRC-MATURA, MRC-PSORT and MRC-MASTERPLANS projects. The project is also being used as a successful exemplar for multiple MRC stratified medicine applications. 
 
Description CRO Chiltern Programme 
Organisation Chiltern International
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution n/a
Collaborator Contribution In 2013 Chiltern Activate was employed to facilitate TACERA study (early RA longitudinal study, a part of RA-MAP consortium) set up, which resulted in significant improvement of recruitment process. From 1st April 2014 the Clinical Monitoring team at Chiltern has been re-engaged to support recruitment at poorly performing sites.
Impact The RA-MAP consortium benefitted from this professional partnership by Chiltern's experience in facilitation of clinical study set up and recruitment processes.
Start Year 2013
 
Description IMI consortium 
Organisation Leibniz Association
Department German Rheumatism Research Centre (DRFZ)
Country Germany, Federal Republic of 
Sector Charity/Non Profit 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description IMI consortium 
Organisation Leiden University Medical Center (LUMC)
Department Department of Rheumatology
Country Netherlands, Kingdom of the 
Sector Hospitals 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description IMI consortium 
Organisation Royal Berkshire Hospital
Department Rheumatology Department
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Hospitals 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description IMI consortium 
Organisation The Karolinska Institute
Country Sweden, Kingdom of 
Sector Academic/University 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description IMI consortium 
Organisation University Hospital Erlangen
Department Department of Rheumatology and Immunology
Country Germany, Federal Republic of 
Sector Academic/University 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description IMI consortium 
Organisation University of Bath
Department Rheumatology
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description IMI consortium 
Organisation University of Birmingham
Department Institute of Cancer and Genomic Sciences
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description IMI consortium 
Organisation University of Glasgow
Department Department of Rheumatology
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description IMI consortium 
Organisation University of Queensland
Country Australia, Commonwealth of 
Sector Academic/University 
PI Contribution As a consequence of AuToDeCRA, we have been invited to partipicate in an EU-IMI proposal for tolerance-inducing therapies in rheumatic disease
Collaborator Contribution The grant is currently being prepared but I anticipate that there will be an opportunity to include a further tolDC trial in the application.
Impact None as yet. The initial output will be a funding application.
Start Year 2015
 
Description King's Health Partners (Viapath) 
Organisation Viapath
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution n/a
Collaborator Contribution Partnership with King's Health Partners (Viapath) to undertake assays for rheumatoid factor and anti-CCP antibodies, and high sensitivity CRP assays in serum from the first 300 patients recruited to the PREVeNT RA cohort of first degree relatives of patients with RA.
Impact None yet.
Start Year 2014
 
Description MATURA consortium 
Organisation Cardiff University
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation King's College London (KCL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation Queen Mary University of London (QMUL)
Department William Harvey Research Institute
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University College London (UCL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University of Birmingham
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University of Edinburgh
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University of Glasgow
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University of Hertfordshire
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University of Leeds
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University of Manchester
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University of Oxford
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description MATURA consortium 
Organisation University of Sheffield
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution recruitment to the STRAP trial proteomic analyses
Collaborator Contribution The overarching mission of the MATURA Consortium is to improve patient care in rheumatoid arthritis (RA) by rationalising therapy decisions through the use of a stratified medicines approach. Background: RA provides the ideal setting for the introduction of a stratified medicine approach because, first, the treatment is standardised in England through National Institute of Health and Clinical Excellence (NICE) guidance such that methotrexate (MTX) is the first choice disease modifying anti-rheumatic drug (DMARD); patients who fail to respond to MTX and at least one other DMARD are eligible for biologic TNF pathway blocking drugs (anti- TNFs) or, more recently IL6 pathway blocking drugs, tocilizumab (TOC), and those who fail to respond to anti-TNF can then be switched to the biologic B-cell depleting therapy, rituximab (RTX). Second, it is well established that there is a significant non - response rate to each drug (MTX (45% by 2 years), anti-TNF (25% by 6 months) and RTX (40% by 6 months). Third, the biologic drugs (anti-TNF, TOC and RTX) are expensive and all 4 drugs are associated with serious adverse events; hence, identifying those patients least likely to respond would improve the cost-benefit analysis. Finally, introduction of early, effective therapy has consistently been shown to improve long-term outcomes including joint damage, disability and employment. Aim: To identify treatment response predictors which will allow the allocation of patients to strata defined by the therapy they are most likely to respond to, early in the disease process. Methods: Two parallel workstrands (WS) will investigate synovial tissue (WS.1) and peripheral blood (WS.2) to identify biomarkers of response. Thus, in WS.1 we shall search for tissue-driven biomarkers and blood correlates in the largest synovial tissue biobank of this type (2 time points 0 & 6 months biopsy) in the world & clinical datasets (over 200 patients immediately available). In addition, in a prospective randomised clinical trial (adaptive design) we will test the hypothesis that discrete cellular and molecular signatures in the synovial tissue ("pathotypes") will enrich for response to existing biologic therapies. In WS.2, we will take advantage of the large observational cohorts of patient samples either already collected or which could be collected for minimal cost to undertake a comprehensive analysis to identify genetic, genomic, transcriptomic, proteomic or, more likely, a combination of these factors that will reliably identify responders/non-responders to each of the drugs. These collections include biological samples from over 3,000 anti-TNF-, 1,500 MTX-, 1,200 RTX- and 200 TOC-treated subjects. The two WSs are fully integrated through "multi-omic" approaches that constitute cross-cutting themes (CTs) that will converge in a large analytical and modelling package driven by experts in Bioinformatics and Statistics and allow preliminary health economic assessments of identified biomarkers. Finally, in collaboration with our Industry partners we have drawn up plans to commercialize potential diagnostics for patient benefit and wealth generation. Outcome: By the end of the study, we will have identified biomarkers of response for four of the most commonly used drugs in the treatment of RA. The study design allows a comprehensive and cohesive assault on the problem of identifying, which patients will respond best to which treatments in RA and has the potential for enormous clinical and economic impact.
Impact Medicine statistics bioinformatics multiple industry partners
Start Year 2014
 
Description Partnership between University of Birmingham and Protagen 
Organisation Protagen AG
Country Germany, Federal Republic of 
Sector Private 
PI Contribution Partnership between UoB and Protagen to look at autoantibody profiles in arthritis associated with anti-PD1 therapy. This arose in part through contacts made at RA-MAP. Transfer of samples governed by MTA.
Collaborator Contribution Partnership between UoB and Protagen to look at autoantibody profiles in arthritis associated with anti-PD1 therapy. This arose in part through contacts made at RA-MAP. Transfer of samples governed by MTA.
Impact None yet (autoantibody profiling in arthritis patients associated with anti-PD1 therapy)
Start Year 2016
 
Description Protagen joins as a new RA-MAP partner 
Organisation Protagen AG
Country Germany, Federal Republic of 
Sector Private 
PI Contribution Serum samples from early RA cohort (TACERA study, n=275) together with healthy controls (from Vaccine Study, n=50) will be provided to Protagen for autoantibody profiling by Protagen's SeroTag® platform.
Collaborator Contribution Protagen has examined autoantibodies to over 7,000 human proteins in the serum samples provided by the RA-MAP consortium. Protagen AG provided the technological platform, ran the analytical lab work, the statistical analysis and covered its own operational costs.
Impact None yet.
Start Year 2015
 
Description RA-MAP Consortium 
Organisation Abbott UK
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation Amgen Inc
Country United States of America 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation AstraZeneca
Department MedImmune
Country United States of America 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation AstraZeneca
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation Bristol-Myers Squibb
Country United States of America 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation European Translational Information and Knowledge Management Services (eTRIKS)
Country European Union (EU) 
Sector Charity/Non Profit 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation GlaxoSmithKline (GSK)
Country Global 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation Johnson & Johnson
Department Janssen Pharmaceuticals
Country United States of America 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation King's College London (KCL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation Medical Research Council (MRC)
Department MRC Biostatistics Unit
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation Pfizer Ltd
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation Queen Mary University of London (QMUL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation Roche
Country Global 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation UCB Pharma
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation University College London (UCL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation University of Birmingham
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation University of Glasgow
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation University of Leeds
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation University of Manchester
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description RA-MAP Consortium 
Organisation University of Oxford
Department Kennedy Institute, OCDEM, NDORMS
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The collaboration is led and coordinated by Newcastle University. There are 2 Work Packages. Newcastle University lead and contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples. Newcastle University contribute to WP1, by recruiting early RA patients to the TACERA study. To eTRIKs the provision of clinically curated "omics" datasets to drive the development of a common KM platform to store data and allow the comparative analysis of clinical data
Collaborator Contribution 7 Academic partners contribute to WP2, "the development of an immunological toolkit" which is based on the development of assays and the identification of biomarkers from early RA clinical samples and will also contribute to WP1, by recruiting early RA patients to the TACERA study. * MRC Biostatistics Unit have provided SAPs for each of the studies *KCL lead the TACERA study *Glasgow lead the Vaccine Substudy on healthy vaccinees *Manchester lead PREVEnTRA to establish a cohort of First Degree Relatives of RA patients *Manchester University lead and coordinate the collation of RCT patient level data to identify Predictors of Remission. *Industry partners provide "in kind" support for 1. Study Operations and Coordination 2. Bioinformatics, statistics and data analysis expertise 3. Data analysis platforms and knowledge management In particular a Consortium of industrial partners (eTRIKs) have provided secure data storage via access to a KM platform (Transmart). Expertise in Knowledge Management. Namely provision of specialist expertise i) to develop the database to accept data types from various technology platforms and ii) to link data storage to specific analysis software Expertise as In kind contributions from company partners has been valued at £111,082 with personnel rates based on full loaded costings. This amounts to ~12.7% of the value of the MRC grant awarded to cover project work in the first year.
Impact N/A Too early in project to report outputs
Start Year 2012
 
Description SOMAlogic (CRO) 
Organisation SomaLogic
Country United States of America 
Sector Private 
PI Contribution Plasma samples from RA-MAP TACERA study and Vaccine study were provided for SOMAscan proteomics analysis, The resulting data have been extensively analysed by the industry members of the RA-MAP consortium. The cost of the analysis has been covered by crowd sourcing amongst the RA-MAP industry partners (£90K).
Collaborator Contribution Provision of SOMAscan proteomics analysis of TACERA baseline and 6 month plasma samples, and healthy control samples from the vaccine study.
Impact RA disease stratification of TACERA patients.
Start Year 2016
 
Description SimOmics Ltd 
Organisation Simomics Ltd
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution Provision of RA-MAP omics dataset for systems immunology collaborative project
Collaborator Contribution SimOmics has been working closely with the team of systems immunologists in the RA-MAP consortium since Q1 2016. They contribute with systems analysis of RA-MAP RA omics database and metabolic flux analysis.
Impact None yet
Start Year 2016
 
Description Tepnel Pharma Services 
Organisation Tepnel Pharma Services
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution Providing biological materials arising from TACERA clinical study cohort for RNA processing
Collaborator Contribution RNA processing and miicroarray services for samples deried from TACERA clinical study
Impact Tepnel has taken up the role of RNA processing and RNA microarray which feeds directly into Transcriptomics package of RA-MAP.
Start Year 2015
 
Description WTCHG for NGS 
Organisation Wellcome Trust Centre for Human Genetics
Department Oxford Genomics Centre
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution RA-MAP has provided RNA samples from TACERA clinical study cohort.
Collaborator Contribution Oxford Genomics has provided next generation sequencing of TACERA study RNA materials.
Impact Oxford Genomics has provided expertise in generating NGS data for RA-MAP consortium.
Start Year 2015
 
Description 'Behind the scenes' - open evening event at the Manchester Royal Infirmary rheumatology department 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact "Behind the scenes" - open evening event was held at the Manchester Royal Infirmary rheumatology department, May 2015. Patients and carers were invited to meet staff and discuss research options - talks, examples of how research is conducted, opportunity to speak to research staff
Year(s) Of Engagement Activity 2015
 
Description 'Platform for Investigation' Event at Manchester Muserum of Science and Industry 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Manchester researchers were involved in awareness-raising activities at the Manchester Museum of Science and Industry held in April 2015. One day event with 800+ visitors, mainly families with children.
Year(s) Of Engagement Activity 2015
URL http://www.cmft.nhs.uk/media-centre/latest-news/explore-joints-and-genes-at-the-museum-of-science-an...
 
Description 9th International Symposium on Uveitis Dublin 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Lecture on Biologics in Rheumatology
Year(s) Of Engagement Activity 2016
 
Description ACR 2016 Washington 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Keynote address on 'Biologic Agents'
Year(s) Of Engagement Activity 2016
 
Description ARUK Arthritis Matters 2014 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact There was useful discussion after my presentation about the reach of charitable funding

Patients volunteered to join TRAFIC steering group
Year(s) Of Engagement Activity 2014
URL http://www.musculoskeletalresearch.com/2014/07/arthritis-matters-2014.html
 
Description ARUK Strategy Meeting Newcastle 2016 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Supporters
Results and Impact Strategy discussion with Liam O'Toole and Steve Simpson
Year(s) Of Engagement Activity 2016
 
Description BT-CURE Workshop - Stockholm 2016 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact AuToDeCRA Lecture and RT-CURE IMI proposal
Year(s) Of Engagement Activity 2016
 
Description BT-CURE workshop May 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact This was a workshop of an existing EU-FP& consortium, which is now developing an IMI application for tolerogenic therapies in RA. I was invited to participate as a member of the proposed IMI academic/industry consortium
Year(s) Of Engagement Activity 2016
 
Description Biomedical Research Unit Open Day (Manchester) - Disease Prevention 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact The Biomedical Research Unit (Musculoskeletal) in Manchester held its annual open day in May 2014, with this year's theme being on disease prevention. The open day provided staff from the regional institutions, hospitals and members of public to learn more about the research being carried out into disease prevention. This included a presentation given by Professor Ian Bruce on the PREVeNT RA study, introducing the study focussed on prevention of rheumatoid arthritis.

Increased public awareness of currently on-going studies aimed at disease prevention, in particular rheumatoid arthritis.
Year(s) Of Engagement Activity 2014
 
Description Cafe Scientifique (PREVeNT RA), Cockermouth, Cumbria 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Postgraduate students
Results and Impact Professor Ian Bruce (PI for the PREVeNT RA study) gave a presentation of arthritis, based on his research. It provoked significant discussion about how lifestyle may influence arthritis development.
Year(s) Of Engagement Activity 2015
 
Description Cafe Scientifique (PREVeNT RA), Pendle, Lancashire 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Professor Ian Bruce (PI for the PREVeNT RA study) gave a presentation of arthritis, based on his research. It provoked significant discussion about how lifestyle may influence arthritis development.

Professor Bruce has been invited to give a further talk and the group sent a recording of his talk to other similar groups in England to raise awareness.
Year(s) Of Engagement Activity 2014
 
Description Central & Eastern European Immunology Forum Bucharest 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact New Treatments for Immune Mediated Inflammatory Diseases
Year(s) Of Engagement Activity 2016
 
Description Clinical Decision Making - Statistics and Health Economics 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Latent variable methods for clinical decision tools.
Year(s) Of Engagement Activity 2017
 
Description Conservative Muslim Forum (London) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Professor Ian Bruce presented a talk to explore the question "Precision Medicine : An Achievable Goal?"
He discussed how precisely can diseases be treated in a way that is specific to the individual patient. He gave an in depth analysis of research in Rheumatology and the fact that there are 8 million people affected by the disease. Despite the complexity of the subject, Professor Bruce managed to make it accessible to the layman.
Professor Bruce alos talked about how research in the UK is fundedm and gave a breakdown of the various research being done by Medical Research Council and the National Institute of Health Research. Whilst the NHS's total budget is over £100 billion, the share devoted to research is under 3%.
For most people, the most fascinating part of the evening was listening to Professor Bruce on the general theme of medication. He he talked about medicine being "partly art, partly science." Most drugs prescribing is on a trial and error / best guess basis, using the likely benefit to the average person. He talked about "personalised medicine" which would target the medicine to the individual patient, and "stratified medicine" which groups patients into categories to assess which medicine to use, being intermediate between using data for the average person and data for the specific individual.
Year(s) Of Engagement Activity 2015
URL http://www.conservativemuslimforum.com/news~events/news-&-past-events/health-event-precision-medicin...
 
Description DRFZ Scientific Advisory Board Meeting Berlin 2016 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact DRFZ is Germany's premier Rheumatology Institute - Radbruch
Year(s) Of Engagement Activity 2016
 
Description EMEUNET Meeting Lisbon 2016 Immune Tolerance - Where Next? 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Immune Tolerance: RA - Where Next?
Year(s) Of Engagement Activity 2016
 
Description EULAR 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Prospective collaboration with Pfizer
Year(s) Of Engagement Activity 2015
 
Description EULAR 2016 London 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Chaired the satellite symposium on Biosimilars - Kweim, Dorner - presentation on Refractory RA
Year(s) Of Engagement Activity 2016
 
Description Efficient Medical Technology Development 2017 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Facilitated workshop mapping roadblocks to the development pathway for new technologies.
Year(s) Of Engagement Activity 2017
 
Description GSK Industry Engagement Visit Newcastle 2016 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Explored shared interests - potential for interaction - biopsy procedures
Year(s) Of Engagement Activity 2016
 
Description Genesis Conference (London) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dr Mike Barnes presented a talk entitled: Technologies empowering Omics in the sessioin "Empowering Technologies"
Year(s) Of Engagement Activity 2015
URL http://www.cambridgeahead.co.uk/2015/12/genesis-2015-london-10th-december/
 
Description Immune mediated Inflammatory Diseases Workshop: Wellcome Trust 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This 2 day workshop brought together a wide spectrum of experts across immune mediated diseases to discuss challenges and future opportunities to learn more about immune mediated conditions. Several potential collaborations were discussed
Year(s) Of Engagement Activity 2017
 
Description Immunogenicity Research Forum 2015 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Prospective collaborations
Year(s) Of Engagement Activity 2015
 
Description International Psoriasis Council Symposium, Munich September 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I spoke on P4 medicine in rheumatology and how such an approach can better address patient stratification
Year(s) Of Engagement Activity 2016
 
Description Inventory of Trials Study Workshop on Predictors of Remission Study 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Workshop for the Predictors of Remission study was organised in Manchester by Prof Jane Worthington, Prof Deborah Symmons, Prof Ian Bruce and Ms Fiona Stirling. The workshop provided an opportunity to feed back information and analyses of the pooled clinical datasets from the 7 consortium member organisations. The meeting was successful, supported by approximately 20 participants contributing from these organisations (mixture of academic and industry partners).

The findings of the study are planned to be incorporated into a manuscript under preparation by Prof Deborah Symmons. This workshop also promoted further data to be produced in order to strengthen the powering of the results. In addition, Brian Tom (study statistician for the RA-MAP consortium) was invited to speak at PSI (Statisticians in the Pharmaceutical Industry) conference in May 2015.
Year(s) Of Engagement Activity 2014
 
Description JDRF Workshop - Common Mechanisms of Autoimmune Conditions 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Prospective collaborations
Year(s) Of Engagement Activity 2015
 
Description Janssen Disease Area Stronghold Scientific Symposium Newark 2016 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Featuring imaging presentations.
Year(s) Of Engagement Activity 2016
 
Description Lecture on "Stratified approaches to the treatment of rheumatoid arthritis" (Newcastle University MSc in Genomic Medicine) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Newcastle PI John Isaacs gave a lecture on stratified medicine in RA to the Genomics Medicine MSc at Newcastle University. This was provided to medical students who all work full time in the NHS.
Year(s) Of Engagement Activity 2016
 
Description MATURA Workshop 2017 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentations by ES and CMB
Year(s) Of Engagement Activity 2017
 
Description MRC DPFS Panel Meeting - London 2016 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Reviewed seven outline applications and two full applications for MRC Development Pathway Funding Scheme.
Year(s) Of Engagement Activity 2016
 
Description MRC Platforms Workshop 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dr Michael Barnes presented a talk entitled "Platforms for Data integration"
Year(s) Of Engagement Activity 2015
 
Description MRC RA-MAP CMB and PSG Meetings London 2016 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Strategic planning around future research directed at predictors of remission in RA.
Year(s) Of Engagement Activity 2016
 
Description MRC Research Strategy Visit 2016 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Supporters
Results and Impact Reviewed medical research at Newcastle highlighting achievements in experimental medicine and translational research and identifying improvement opportunities.
Year(s) Of Engagement Activity 2016
 
Description MRC Stratified Medicine Consortia in Immune-Inflammatory Diseases Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This workshop explored common characteristics across a number of key consortia and has helped to better understand common challenges in the mechanisms of these conditions as well as common methodological challenges
Year(s) Of Engagement Activity 2016
 
Description MRC Stratified Medicine Initiative - Strategy Workshop 2013 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact MRC Stratified Medicine Strategy Workshop
4th July 2013
London
Science of Strat Med Consortia -

Assisted the broader community in better understanding the opportunities and challenges posed by taking a stratified medicine approach
Year(s) Of Engagement Activity 2013
 
Description MRC Technology Strategy Board Stratified Medicine Showcase 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact MRC Technology Strategy Board Stratified Medicine Showcase
30th Oct 2013
London
Delivering the Impact

To be reported
Year(s) Of Engagement Activity 2013
 
Description MRC Translational Research Group 2016 Strategy Meeting 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Supporters
Results and Impact Developing translational research strategy for the UK
Year(s) Of Engagement Activity 2016
 
Description MRCstratified medicine workshop April 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Audience of approximately 20 PIs plus MRC staff - a view from the expert panel

Enhanced recognition for Newcastle as a centre for translational medicine
Year(s) Of Engagement Activity 2014
 
Description MSc Genomics Newcastle 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Postgraduate students
Results and Impact Stratified Medicine in RA
Year(s) Of Engagement Activity 2016
 
Description Methodology for Stratified Medicine 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Prospective collaborations
Year(s) Of Engagement Activity 2015
 
Description Open Innovation in the NHS workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact On the 2nd April 2014 the Academy of Medical Sciences hosted a workshop in partnership with the Centre for the Advancement of Sustainable Medical Innovation (CASMI) to bring together members of academia, industry, the NHS, funding bodies and IP experts. The discussion focused on the key issues and opportunities surrounding collaboration with the NHS, focusing particularly on 'open innovation' models of partnership. Professor Andrew Cope (PI of RA-MAP study) contributed by presenting the MRC/ABPI-funded RA-MAP consortium as an exemplar of open innovation in the NHS and model of academia-NHS-industry collaboration.

Delegates enjoyed four case presentations that highlighted the advantages of open collaboration models and also some of the barriers and frustration involved with these partnerships. Following a candid and constructive period of discussion, delegates highlighted four areas that they considered to be the most significant barriers to open innovation. These were: lack of metrics, poor incentivisation and reward for innovation, cultural conflicts between sectors and poor use of existing structures. Delegates then worked in groups to consider novel solutions to overcoming these barriers and facilitate open innovation partnerships with the NHS.
Year(s) Of Engagement Activity 2014
URL http://www.acmedsci.ac.uk/policy/policy-projects/open-innovation-in-the-nhs/
 
Description Personalized Medicine - Brazil 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Lecture tour presenting four talks on Personalized Medicine at three research centres in Brazil.
Year(s) Of Engagement Activity 2016
 
Description Precision Medicine UK 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact NOCRI joined UK leaders in the research, development and commercialisation of precision medicine for a one-day event this week designed to encourage new partnerships and highlight new opportunities in the field.

The Precision Medicine UK: Collaboration Nation event at De Vere Holborn Bars, London, on 9 December was organised on behalf of the Stratified Medicine Innovation Platform by Innovate UK,, National Institute for Health Research, Cancer Research UK,Medical Research Council, Invest Northern Ireland, Health and Care Research Wales and the Knowledge Transfer Network, with the NIHR Office for Clinical Research Infrastructure (NOCRI) coordinating the NIHR's involvement.

The day formed part of a programme to make the UK a world leader in precision medicine and provided real-world examples of the discovery and development of precision medicine solutions, through talks, panel discussions, workshops and exhibitions with the opportunity to arrange one-to-one partnering meetings.

Precision medicine is an emerging approach to the treatment and diagnosis of disease that takes into account variations in a patient's genes, environment and lifestyle. It aims to better target treatments to an individual's circumstances to improve outcomes for patients.

Representatives from across the NIHR were involved in the day and presented on a range of projects and funding programmes. Professor Bryan Williams of NIHR UCLH Biomedical Research Centre joined the first panel of the day which highlighted UK investments in the invention and evaluation phase of research. Professor Williams' highlighted key NIHR's investments in this space and provided examples of exciting precision medicine projects from UCLH BRC. In addition, a number of NIHR precision medicine projects were presented during the disease area specific showcase sessions. This included Professor Costantino Pitzalis who presented the THERAPIST study on behalf of the NIHR Translational Research Partnership, Professor Simon Mead's who presented a project at NIHR Queen's Square Biomedical Research Unit on the "dementia chip" and Professor Tariq Sadiq's who presented on Capacity Building and Delivery of Precision Medicine in Sexual Health, through NIHR Funding. Mark Samuels, Managing Director of NOCRI, also chaired a discussion panel themed 'Enabling Collaboration', which highlighted the value of collaborative working between companies, academics, charities and patients.

The event saw the launch by the chief executive of Innovate UK, Dr Ruth McKernan, of a new map of the precision medicine landscape.

A whole range of organisations, including charities, health bodies and devolved administrations are coordinating their work under the umbrella of Innovate UK's Stratified Medicine Innovation Platform, with NOCRI representing the NIHR.
Year(s) Of Engagement Activity 2015
URL http://www.uk-pgx-stratmed.co.uk/index.php/event-calendar/icalrepeat.detail/2015/12/09/213/73/-
 
Description R&D conference. Health Research - partnerships for success 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact This was a conference at BMA House organised by ABPI, BIA and NOCRI - to explain largely to an industrial audience, how the collaborative landscape (Industry/academia) was evolving. Other speakers included Lord Howe and Sir John Savill. There were approximately 250 attendees.

New contacts from potential industrial collaborative partners
Year(s) Of Engagement Activity 2012
 
Description RA-MAP Biostatistics overview (presentation at MATURA meeting) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact RA-MAP Biostatistics Overview was presented by Brian Tom (RA-MAP statistician PI) at MATURA Scientific Meeting, where the statistical approaches used in RA-MAP were outlined, which may be relevant to the MRC Stratified Medicine Initiative MATURA consortium
Year(s) Of Engagement Activity 2017
 
Description RA-MAP Presentation at PSI Immunology Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Brian Tom, the leading PI statistician of RA-MAP, provided RA-MAP project overview and statistical approaches taken in a presentation given at PSI (Promoting Statistical Insight) Immunology meeting to industry statisticians.
Year(s) Of Engagement Activity 2016
 
Description RA-MAP data infrastructure and analysis strategy presented at Wellcome Trust Immune Modulated Inflammatory Disease Workshop (Feb 2017) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact RA-Map data infrastructure and analysis strategy was presented
Year(s) Of Engagement Activity 2017
 
Description RA-MAP data infrastructure was presented as an exemlar at the MRC Stratified Medicine Applicats Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact RA-Map data infrastructure was presented as an exemplar at the MRC Stratified Medicine applicants workshop
Year(s) Of Engagement Activity 2017
 
Description RA-MAP project presentation as a Startified Medicine exemplar at the MRC-eMedLab Stratified Medicine Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact The RA-Map project was presented as a Stratified Medicine exemplar at the MRC-eMedLab Stratified Medicine workshop
Year(s) Of Engagement Activity 2016
 
Description RACE Scientific Advisory Board Meeting 2016 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentations on TRAFIC and BIO-FLARE as worked examples of our experimental medicine approach.
Year(s) Of Engagement Activity 2016
 
Description RACE launch 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Interesting discussions, including with an Olympian

None yet
Year(s) Of Engagement Activity 2014
 
Description Remission Accomplished - Houses of Parliament 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/parliamentarians
Results and Impact There was an active discussion around the therapy of inflammatory arthritis and its future direction.

None yet
Year(s) Of Engagement Activity 2014
 
Description Research Engagement Poster Campaign 2015 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Poster campaign describing research in lay terms for public and patients audience. To promote engagement in research in the NE.

Public and patients expressed interest in participating in research.
Year(s) Of Engagement Activity 2015
 
Description Rheumatoid Arthritis Strategic Review, Newcastle, 2015 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Strategic realignment of research activities
Year(s) Of Engagement Activity 2015
 
Description Rheumatoid Arthritis: What's New? Karolinska, Sweden 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Novel and targeted RA treatments.
Year(s) Of Engagement Activity 2016
 
Description Rheumatology Research Patient Partnership (R2P2) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Education and empowernig Patient Partners to participate in research design and oversight.

Education and empowering Patient Partners to participate in research design and oversight. The Rheumatology Research Group in Birmingham recognise the importance of involvement of patients and members of the general public in all aspects of the research process, including initial project development and grant applications, the design and implementation of the studies as well as their dissemination.
Year(s) Of Engagement Activity 2014
URL http://www.birmingham.ac.uk/research/activity/mds/projects/ii/R2P2/index.aspx
 
Description Roche Systems Pharmacology Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact A systems approach to investigating drug response variability in RA
Year(s) Of Engagement Activity 2015
 
Description Seminar at Altnagelvin Hospital 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Patients, carers and/or patient groups
Results and Impact Prof Ian Bruce provided a seminar about pevention of RA based on PREVENT RA study.
Year(s) Of Engagement Activity 2015
 
Description Stockholm - RA: What's Next - 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited Lecture
Year(s) Of Engagement Activity 2016
 
Description Stratified Medicine Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Prospective collaborations
Year(s) Of Engagement Activity 2015
 
Description TACERA Premier 2 London 2016 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Hosted the day. Introductory Presentation.
Year(s) Of Engagement Activity 2016
 
Description UK Autoimmunity Workshop - Defining the Grand Challenges - Clinical Trials, New Therapeutics, Repurposing 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact JDRF
MRC
ARUK
WT
Year(s) Of Engagement Activity 2016