Abatacept vs Adalimumab in Adults with Early Rheumatoid Arthritis - IM101-863
Research type
Research Study
Full title
A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate
IRAS ID
1003806
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2020-000350-96
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 trial in adults with early rheumatoid arthritis (RA). To be eligible, they must have antibodies directed against themselves (called auto-antibodies) and have or have not a specific form of genetic marker associated to RA.
The purpose of this study is to compare the effectiveness of two approved drugs for RA, abatacept or adalimumab, both given with methotrexate (MTX).
There are three parts to this study (screening, treatment and follow-up).
The screening part of the study helps determine eligibility and can last up to 28 days (or longer if needed).
Once confirmed eligible, patients will enter the treatment period. The treatment period is divided into 2 parts. The 24-week single blind treatment period (SBTP) followed by the 80-week open label treatment period (OLTP).
During the single blind treatment period, patients will be randomised (in a 1:1 fashion) to either 125 mg abatacept weekly or 40 mg adalimumab once every 2 weeks. Both drugs are given sub-cutaneously (injection under the skin).
At Week 24, all patients will switch to 125 mg abatacept once weekly. The OLTP lasts 80 weeks.
Patients will continue to take their methotrexate at the same dose throughout both treatment periods. In addition, they will take folic acid, folinic acid, or leucovorin whilst taking methotrexate (as standard).
After the 80 week open label treatment period (or if the patient comes off treatment earlier), patients will enter the last part of the study, the follow-up period. Patients will be followed for 24 weeks after their last dose of study treatment. They will visit the hospital twice during this period.
Patients will attend about 22 visits to the hospital under the care of a rheumatologist. They will undergo blood tests; physical exams including vital signs (such as blood pressure and heart rate), an x-ray to the chest and finally asked to complete some health related questionnaires.
The study is funded by Bristol Myers Squibb.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0267
Date of REC Opinion
27 Oct 2021
REC opinion
Further Information Favourable Opinion