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5月28日最近更新: 2024年7月15日

适应症

试验速览

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•- Females, ages = 18 years or local age of majority.
•- Males, ages = 18 years or local age of majority.
•- Participants have early RA, defined as symptoms of RA that started = 12 months prior to screening and satisfied the ACR/EULAR 2010 criteria for the classification of RA at some point during the 12-month period.
•- Participants will have the HLA-DRB1 alleles genotyped during screening and will be identified as carrying at least 1 copy of the SE alleles or not. No greater than 25% of randomized participants may be SE negative.
•- Participants must be naive to any targeted (biologic or nonbiologic) DMARDs, conventional synthetic DMARDs other than MTX, investigational therapies for RA.
•- Participants must have been 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.
•- Participants have an anti-CCP-2 test that is > 3× ULN and are positive for RF according to central lab testing during screening.
•- Participants must have at least a DAS28-CRP = 3.2 at screening.
•- Participants must have currently at least 3 tender and at least 3 swollen joints (excluding distal interphalangeals) 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.
•- Participants with autoimmune disease other than RA or currently active fibromyalgia.
•- Prior history of or current inflammatory joint disease other than RA.
•- Participants at risk for TB infection.
•- Participants with recent acute infection. In the case of prior SARS-CoV-2 infection within 30 days prior to enrollment, symptoms must have completely resolved with no clinically significant sequelae that would indicate a higher risk of participation in the study.
•- Participants with history of primary immunodeficiency.
•- Participants who have received any live vaccines within 3 months of the study drug administration.
•- Participants who have received live attenuated or replication-competent vector SARS-CoV-2 vaccines within 3 months of study enrollment.
•- Participants for whom 5 or more joints cannot be assessed for tenderness or swelling (ie, due to surgery, fusion, amputation, etc).
•- Participants who have had previous exposure to abatacept or adalimumab.
•- Participants who have received an IM, IV, or intra-articular administration of a corticosteroid within 4 weeks prior to randomization.
•- Hepatitis B surface antigen (HBsAg)-positive, or hepatitis B core antibody (HBcAb) positive participants with detectable hepatitis B viral deoxyribonucleic acid (DNA).
•- Hepatitis C antibody (HcAb)-positive participants with detectable hepatitis C viral RNA.
•- History of certain types of infections

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