At a glance
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A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept Administered Intravenously in Korean Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate
In Brief
A Phase 3 clinical trial evaluating Abatacept, Methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 113 participants across 7 sites.
Detailed 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
Study Details
Timeline
Interventions
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
Tablets, Oral, ≥ 15 mg, weekly, 6 months
IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
Solution, intravenous, 10 mg/kg, every 28 days
Tablets, oral, 15 mg weekly to be adjusted according to patient condition