Trial Information

Summary: A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate

A randomized, double-blind study of the effect of ocrelizumab in combination with methotrexate, compared to methotrexate alone, on the treatment response in methotrexate-naive patients with active rheumatoid arthritis.

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200 mg i.v. or ocrelizumab 500 mg i.v. on days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20 mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. In the US this study is sponsored/managed by Genentech, under protocol no. ACT3984g.

Patient Inclusion Criteria:

• Adult patients, = 18 years of age;
• Rheumatoid arthritis for 3 months-5 years;
• Naive to methotrexate;
• If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to baseline.

Patient 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.

Primary Outcomes: Change from baseline in modified total Sharp score at week 52

Key Secondary Outcomes: Efficacy:HAQ-DI, ACR20/50/70/90,DAS28,EULAR response rate, erosion score, JSN score,radiographic progression, SF-36, FACIT-F. Safety: AEs.lab parameters

Intervention Type: Drug
Intervention Name: ocrelizumab
Sponsor: Hoffmann-La Roche; Genentech Inc

For more information,

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