Conditions: Rheumatoid Arthritis
Keywords: anti-CD20 stage CD20 RA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1015
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received two intravenous (IV) infusion matching placebo to ocrelizumab on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 milligram (mg) was administered weekly. arm 2: Participants received two IV infusion of ocrelizumab 200 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly. arm 3: Participants received two IV infusion of ocrelizumab 500 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.

Interventions: intervention 1: Methotrexate intervention 2: ocrelizumab intervention 3: Placebo
Intervention descriptions: intervention 1: Methotrexate tablet was administered orally at a dose 7.5-25 mg intervention 2: Ocrelizumab was administered via IV infusion at a dose specified in arm description intervention 3: Matching placebo to ocrelizumab was administered via IV infusion

Protocol document: