Trial Information

Summary: A Study of Ocrelizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to anti-TNF-alpha Therapy.

Status: Recruiting

Protocol Number: WA20495

Sponsor: Hoffmann-La Roche; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of ocrelizumab, compared to placebo, on signs and symptoms in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.

Brief Summary: This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15.A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.In the U.S. this trial is sponsored/managed by Genentech. Target sample size is 1000.

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. Percentage of patients with ACR20 response at week 24, and week 48.

Key Secondary Outcomes: 1. Efficacy: ACR50, ACR70, DAS28, EULAR response rate, modified Sharp score, HAQ-DI score, SF-36 and FACIT scores.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2007

Trial Registration Date: 04/17/2007

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 1:53:17 PM