Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

Key Inclusion Criteria

• Presence of active clinical synovitis in at least 2 joints, 1 of which must have been a small joint, for a minimum of 8 weeks prior to screening
• Onset of persistent symptoms ≤ 2 years prior to screening
• Positive test result for anticyclic citrullinated peptides 2
• Methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit
• Biologic naive, including no treatment with an investigational biologic prior to screening
• Disease Activity Score 28 based on C-reactive protein score ≥3.2 at screening
• Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization
• If receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone equivalent) for at least 4 weeks
• Able to undergo magnetic resonance imaging

Key Exclusion Criteria

• Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus)
• Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization
• Scheduled for or anticipating joint replacement surgery
• Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
• History of malignancy in the last 5 years
• Any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection
• At risk for tuberculosis
• Evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment