STRAP version 1
Research type
Research Study
Full title
Stratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab.
IRAS ID
138283
Contact name
Costantino Pitzalis
Contact email
Sponsor organisation
Joint Research & Development Office (QMUL)
Eudract number
2014-003529-16
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Rheumatoid arthritis (RA) is one of the most important chronic inflammatory disorders in the UK and leads to considerable morbidity and an increased mortality. According to the National Audit Office there are 26,000 new cases of RA each year with 582,000 prevalent cases in England. 45% of these people are of working age and within 1 year of diagnosis 30% are unemployed. RA costs the NHS around £560 million annually. Estimates of the total cost of RA to the UK economy, including NHS costs as well as carer costs, the costs of nursing homes, private expenditure, sick leave and work-related disability are £3.8 to £4.8 billion a year.
Biologics have transformed the treatment of Rheumatoid Arthritis. However, the annual cost to the NHS is ~ £160 million and ~40% of patients do not respond (<20% improvement, ACR20). This leaves a major unmet clinical need and a considerable health and economic burden to the NHS: 4,500 new patients /year are started on biologics at the cost of approximately £10K/patient/year. Thus, the identification of the 40% non-responders prior to “blind” therapy would provide: a) better care (avert delay starting a more effective biologic), b) prevent unnecessary exposure to potentially toxic drugs, and c) conceivably save £13-18 million per annum.
The main aim of this study is to integrate disease tissue (synovium) pathology into clinical & imaging algorithms while, at the same time, searching for blood surrogate markers. An even more important question is whether a synovial biopsy can provide valuable information to enrich for response to first biologic therapy and identify the ~40% of patients who are unlikely to respond. Thus, in this study, we propose to use synovial pathobiology to stratify DMARD-inadequate responder patients to first line biologics in a RCT.
REC name
Wales REC 3
REC reference
14/WA/1209
Date of REC Opinion
16 Dec 2014
REC opinion
Further Information Favourable Opinion