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 (STRAP & STRAP-EU)
[ISRCTN: 10618686] [EudraCT: 2014-003529-16] / [EudraCT: 2017-004079-30] [NIHR CRN Portfolio Study ID: 18178]
Status: Closed to recruitment
Maximising Therapeutic Utility in Rheumatoid Arthritis (MATURA) is an ambitious research project jointly funded by MRC and Versus Arthritis to identify and test biomarkers predictive of response to therapy in rheumatoid arthritis (RA), thereby allowing the stratification of patients into groups according to the therapies that are most likely to be effective. The project comprised of two work-streams: Workstream 1 is managed by Prof Costantino Pitzalis the Centre for Experimental Medicine and Rheumatology, and Workstream 2 is managed at The University of Manchester.
An important component of Workstream 1 was the STRAP Trial. This is a randomised control trial that aims to test the utility of synovial histomorphology and B cell numbers together with specific molecular signatures as potential biomarkers to guide therapeutic decisions in patients failing DMARD therapy. The ultimate aim is to improve on current response rates and identify patients more likely to respond. Patients were randomised to receive rituximab, tocilizumab or etanercept following a baseline synovial biopsy.
This trial closed to recruitment in May 2019, there are 21 UK sites and 6 European centres, and a total of 226 patients were recruited. The follow-up period has now been completed. The results will be available in 2021.
STRAP/STRAP-EU Bio & Data-Resource Metrics
Following a synovial biopsy, DMARD-inadequate (ir) patients were randomised to etanercept, rituximab or tocilizumab. In addition to the US-guided synovial biopsy at baseline, STRAP collected a second biopsy at primary end-point in 1/3 of patients as well as matched serum/plasma, DNA, RNA, cryopreserved peripheral blood mononuclear cells (PBMCs) 3 monthly, linked to stringent clinical outcome measures including US and x-ray data.