A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)

A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.

Inclusion criteria:

• Adult patients, ≥18 years of age
• Rheumatoid arthritis for ≥ 3 months
• Inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for ≥ 12 weeks

Exclusion criteria:

• Rheumatic autoimmune disease or inflammatory joint disease, other than RA
• Prior receipt of any biologic therapy for RA
• Concurrent treatment with any DMARD (other than methotrexate)