Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Methotrexate; Abatacept placebo; Methotrexate placebo
Intervention description: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months; Tablets, oral, 2.5 mg, once weekly, 12 months; Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months; Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months
Intervention MeSH terms: Methotrexate; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of the protocol is to demonstrate the ability of abatacept plus
      methotrexate to induce remission in patients with very early rheumatoid arthritis after 12
      months of treatment and to maintain remission following 6 months of drug withdrawal.
    

Eligibility criteria:

        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