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

Bristol-Myers Squibb International Corporation0 个研究点目标入组 400 人开始时间: 2021年7月7日最近更新: 2024年2月26日

研究概览

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•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 340
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- 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

发起方