Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, with inadequate response to methotrexate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 113
Healthy volunteers: no

Brief summary:
The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate

Detailed description:

Arms:
arm 1: None arm 2: (standard of care) arm 3: Open-label extension phase

Interventions: intervention 1: Abatacept intervention 2: Methotrexate intervention 3: Placebo intervention 4: Abatacept intervention 5: Methotrexate
Intervention descriptions: intervention 1: Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months intervention 2: Tablets, Oral, ≥ 15 mg, weekly, 6 months intervention 3: IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months intervention 4: Solution, intravenous, 10 mg/kg, every 28 days intervention 5: Tablets, oral, 15 mg weekly to be adjusted according to patient condition

Protocol document: