Trial Information

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

Status: Recruiting

Protocol Number: WA20497

Sponsor: Hoffmann-La Roche; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: 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.

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 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.In the US this study is sponsored/managed by Genentech, under protocol no. ACT3984g. Target sample size is 420.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: ocrelizumab

Primary Outcome: 1. Change from baseline in modified total Sharp score at week 52

Key Secondary Outcomes: 1. 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

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 2007

Trial Registration Date: 06/15/2007

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: July 14, 2008 at 1:05:05 PM