Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 431
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

Detailed description:

Arms:
arm 1: Days 1-365 arm 2: Days 1-365 arm 3: Days 1-197 arm 4: Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365 arm 5: Days 365 to 729 All participants receive Active Drug

Interventions: intervention 1: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB) intervention 2: Infliximab (INF) + MTX, DB intervention 3: Placebo (PLA) + MTX, DB intervention 4: PLA + MTX switched to ABA+ MTX, DB intervention 5: ABA, open-label (OL)
Intervention descriptions: intervention 1: Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months. intervention 2: Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months. intervention 3: Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. intervention 4: Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months intervention 5: Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months

Protocol document: