A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

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

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

Key Inclusion Criteria:

• Rheumatoid arthritis (RA) for longer than 1 year from the time of the initial diagnosis of RA
• Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
• Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses

Key Exclusion Criteria:

• Evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment