Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 511
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period arm 2: Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period arm 3: Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period

Interventions: intervention 1: Abatacept intervention 2: Methotrexate intervention 3: Abatacept placebo intervention 4: Methotrexate placebo
Intervention descriptions: intervention 1: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months intervention 2: Tablets, oral, 2.5 mg, once weekly, 12 months intervention 3: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months intervention 4: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months

Protocol document: