Official Title: “A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab in Combination With Methotrexate (MTX) Compared to MTX Alone 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 200mg i.v. or ocrelizumab 500mg 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 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: ocrelizumab
  • Intravenous repeating dose
• Drug: placebo
  • Intravenous repeating dose
• Drug: methotrexate
  • Oral repeating dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Change from baseline in the modified total Sharp score
  • Time Frame: Week 52
    Safety Issue?: No

Secondary Measures

• Health Assessments Questionnaire - Disability Index (HAQ-DI) score
  • Time Frame: Week 104
    Safety Issue?: No
• Proportion of patients with a major clinical response
  • Time Frame: Weeks 52 and 104
    Safety Issue?: No
• Proportion of patients achieving Disease Activity Score (DAS28) remission
  • Time Frame: Weeks 24, 52, and 104
    Safety Issue?: No
• Change in DAS28 from baseline
  • Time Frame: Weeks 24, 52, and 104
    Safety Issue?: No
• EULAR response rates
  • Time Frame: Weeks 24, 52, and 104
    Safety Issue?: No
• Proportion of patients achieving an ACR20/ACR50/ACR70/ACR90 response
  • Time Frame: Weeks 24, 52, and 104
    Safety Issue?: No
• Proportion of patients with a reduction of at least 0.25 units in the HAQ-DI score from baseline
  • Time Frame: Weeks 24 and 52
    Safety Issue?: No

Inclusion criteria:

• Age ≥ 18
• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Genentech

Overall Clinical Trial Officials and Contacts

Wolfgang Dummer, M.D. Study Director Genentech  

Overall Contact: Genentech Trial Information Support Line 888-662-6728 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00485589

Study ID Number: ACT3984g

ClinicalTrials.gov Identifier: NCT00485589

Health Authority: United States: Food and Drug Administration

Ex-U.S. Study Information (Ex-US this trial is sponsored/managed by Hoffmann-La Roche)