3TR Precis-The-RA Study
Research type
Research Study
Full title
The 3TR Molecular Pathobiology-Driven Precision Therapy in RA (3TR Precis-The-RA) study
IRAS ID
289895
Contact name
Costantino Pitzalis
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2020-004566-18
ISRCTN Number
ISRCTN44988547
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Rheumatoid arthritis (RA) is a chronic inflammatory disease, characterised by persistent synovitis, systemic inflammation and autoantibodies (particularly to rheumatoid factor and citrullinated peptide). In industrialised countries, RA affects 0.5-1% of adults, with 5-50 per 100,000 new cases annually.
Despite the clinical and radiological benefits of biologic therapies, the vast majority of patients fail to achieve low disease activity or remission. Almost 40% of all patients treated with biologic disease-modifying anti-rheumatic drugs (b-DMARDs) do not experience minimally acceptable improvement. Thus, the treatment of RA patients according to their biomarker would provide better care (avert delay starting a more effective drug) and prevent unnecessary exposure to potentially toxic drugs and additionally be cost saving.
We aim to test whether RNA signatures (biomarkers), in the tissue which surrounds the joints (synovial tissue) from patients with Rheumatoid Arthritis are predictive of response to drug treatments such as biologic disease-modifying anti-rheumatic drugs (b-DMARDs).
Rheumatology patients will undergo a biopsy of their joint, and then will receive either sarilumab or tocilizumab. Half of patients will receive the drug randomly, and the other half will be treated according to their biomarkers. Patients will attend 4-weekly visits up to 12 weeks, followed by a 30-day safety follow up visit.
REC name
South West - Frenchay Research Ethics Committee
REC reference
21/SW/0164
Date of REC Opinion
19 Nov 2021
REC opinion
Favourable Opinion