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

  • End date
    Jul 17, 2025
  • participants needed
  • sponsor
    Bristol-Myers Squibb
Updated on 18 October 2022
rheumatoid factor
cyclic citrullinated peptide antibody


The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.

Condition Rheumatoid Arthritis
Treatment methotrexate, Adalimumab, Abatacept
Clinical Study IdentifierNCT04909801
SponsorBristol-Myers Squibb
Last Modified on18 October 2022


Yes No Not Sure

Inclusion Criteria

Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period
Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization
Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening
At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening
At least 3 tender and at least 3 swollen joints at screening and at randomization

Exclusion Criteria

Women who are breastfeeding
Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia
History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)
At risk for tuberculosis
Recent acute infection
History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
History of infection of a joint prosthesis or artificial joint
History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis)
History of primary immunodeficiency
Current clinical findings or a history of a demyelinating disorder
or more joints cannot be assessed for tenderness or swelling
Other protocol-defined inclusion/exclusion criteria apply
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