Abatacept-Methotrexate combo vs Methotrexate in adults with early RA
Research type
Research Study
Full title
A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive
IRAS ID
182572
Contact name
GCT-SU Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2015-001275-50
Duration of Study in the UK
4 years, 5 months, 14 days
Research summary
Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis, and women are 2 to 3 times more likely to develop the disease compared to men, with a peak incidence between the fourth and sixth decades of life. RA is characterised by joint destruction, impaired physical function, and poor health-related quality of life. Joint erosions can be seen within 6 months of disease onset in the majority of patients, and occurs more rapidly in the first year compared with later disease. There is little evidence that current therapies can reverse the structural damage once it occurs. Remission achieved early in the disease course may prevent debilitating and irreversible joint damage.
The aim of this study is to determine if treatment with abatacept in combination with methotrexate will achieve a higher rate of remission versus methotrexate alone in adults, that have not yet been treated with methotrexate.
Approximately 1000 patients in total are expected to participate in this double-blinded study globally, with about 15 patients taking part in the UK. Patients will be randomly assigned to either a combination therapy of abatacept (subcutaneous injection) plus methotrexate (oral) or abatacept placebo plus methotrexate for a period of 52 weeks. Upon completion of this part of the study, patients will be enrolled into a second part of the study, the “de-escalation period” if they achieve remission (an improvement in their disease). Patients enrolled into this period will receive one of a number of different treatment combinations of abatacept and methotrexate. Patients who do not achieve remission will be put onto open label treatment of abatacept and methotrexate.
Patients will be required to administer the treatment themselves. They will have up to 4 x-rays, undergo physical examinations, have blood and urine samples taken, and be asked to fill in some questionnaires.REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0470
Date of REC Opinion
28 Sep 2015
REC opinion
Further Information Favourable Opinion