Trial Information

Summary: A Study of Ocrelizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate.

Status: Recruiting

Protocol Number: WA20494

Sponsor: Hoffmann-La Roche Ltd; 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 continuing methotrexate treatment.

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, ocrelizumab 200mg iv. or ocrelizumab 500mg iv. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive concomitant methotrexate 7.5mg - 25mg/week at a stable dose. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. In the U.S. this study 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 ACR 20 response at week 24, and week 48.

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

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2007

Trial Registration Date: 04/17/2007

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:12:55 PM