Trial Information

Summary: A Study to Assess the Safety and Efficacy of Retreatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on anti-TNFalfa Therapy

Status: No longer recruiting

Protocol Number: WA17531

Sponsor: Roche Products Ltd.; IDEC Pharmaceuticals Corporation

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of MabThera retreatment on treatment response in patients with active rheumatoid arthritis and inadequate response to anti-TNF therapy

Brief Summary: This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals. Target sample size is 341.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: rituximab[MabThera/Rituxan]

Primary Outcome: 1. Efficacy: Proportion of patients with an ACR20 response

Key Secondary Outcomes: 1. Efficacy: Proportion of patients achieving an ACR50 and ACR70 response; proportion of patients with a EULAR response, or a DAS28 response Safety: Adverse events, laboratory parameters

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 80 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2004

Trial Registration Date: 07/26/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:22:55 PM