3TR-PARTNER-RA
Research type
Research Study
Full title
The 3TR Molecular PAthobiology and PRecision Therapy iN EaRly Rheumatoid Arthritis Study (3TR-PARTNER-RA)
IRAS ID
1008435
Contact name
Costantino Pitzalis
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2024-511470-79
ISRCTN Number
ISRCTN94259329
Research summary
Rheumatoid arthritis (RA) is a chronic inflammatory joint disease which, in industrialised countries, affects 0.5-1% of adults, with 5-50 per 100,000 new cases annually. Uncontrolled active RA causes joint damage, disability, decreased quality of life, and cardiovascular and other comorbidities. There are currently many different treatments approved for use in rheumatoid arthritis which have improved prognosis in the last few decades. The first line treatment includes use of conventional synthetic DMARDs (csDMARDs) such as methotrexate, leflunomide, sulfasalazine and hydroxychloroquine. However, despite the treatments available, 40% of patients fail to respond to first line therapy. There are other drugs, called biological therapies, which are also used to treat rheumatoid arthritis, however, patients are not usually given a biological therapy until they have tried at least 2 csDMARDs already. In this trial, we aim to understand whether starting patients on a biological therapy as part of first line therapy (in this trial, we will investigate a drug called abatacept) can be used to treat rheumatoid arthritis better and reduce the “trial and error” approach that is currently used. We propose to perform a double-blinded, randomised controlled study of patients newly diagnosed with RA (symptoms <12 months) and fulfilling the 2010 ACR/EULAR classification criteria for RA who will undergo a synovial biopsy at baseline and randomised (1:1) to drug (abatacept) and methotrexate or placebo and methotrexate arm. As part of this research, we will analyse participants’ biopsy tissue in the laboratory and try to understand if this can be used to predict how participants’ disease responds to the treatment given. Overall, the trial aims to better understand the immune-pathogenesis of early rheumatoid arthritis and to collect the information that could help define biomarkers for response to treatment.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0277
Date of REC Opinion
13 Dec 2024
REC opinion
Further Information Favourable Opinion