Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate.

Phase 1

Conditions: Rheumatoid Arthritis
MedDRA version: 21.0Level: PTClassification code: 10039073Term: Rheumatoid arthritis Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-506450-20-00

Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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 Creactive 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, Current clinical findings or a history of a demyelinating disorder, 5 or more joints cannot be assessed for tenderness or swelling, 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