A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Running, not enrolling · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT04909801

Run by

Bristol-Myers Squibb

People needed

338

Starts

2021-09-15

Expected to finish

2027-09-01

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 5 or more joints cannot be assessed for tenderness or swelling
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0086 — Los Alamitos, California, United States
• Local Institution - 0041 — Aurora, Colorado, United States
• Local Institution - 0058 — Cumberland, Maryland, United States
• Local Institution - 0038 — Hagerstown, Maryland, United States
• Local Institution - 0084 — Eagan, Minnesota, United States
• Local Institution - 0040 — Freehold, New Jersey, United States
• NYU Langone Ambulatory Care Brooklyn Heights — Brooklyn, New York, United States
• Local Institution - 0082 — Wilmington, North Carolina, United States
• Local Institution - 0127 — Portland, Oregon, United States
• Local Institution - 0031 — Duncansville, Pennsylvania, United States
• Local Institution - 0034 — Jackson, Tennessee, United States
• Local Institution - 0044 — Dallas, Texas, United States
• Local Institution - 0119 — Milwaukee, Wisconsin, United States
• Local Institution - 0012 — CABA, Buenos Aires, Argentina
• Local Institution - 0016 — Quilmes, Buenos Aires, Argentina
• Local Institution - 0014 — San Isidro, Buenos Aires, Argentina
• Local Institution - 0057 — San Miguel de Tucumán, Tucumán Province, Argentina
• Local Institution - 0022 — Buenos Aires, Argentina
• Local Institution - 0023 — Buenos Aires, Argentina
• Local Institution - 0015 — Buenos Aires, Argentina
• Local Institution - 0099 — Córdoba, Argentina
• Local Institution - 0072 — Botany, New South Wales, Australia
• Local Institution - 0062 — Parramatta, New South Wales, Australia
• Local Institution - 0063 — Maroochydore, Queensland, Australia
• Local Institution - 0036 — Fullerton, California, United States

Full record on ClinicalTrials.gov

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