Trial Information

Summary: A Study to Assess the Efficacy and Safety of Retreatment With MabThera (Rituximab) in Patients With Active Rheumatoid Arthritis (RA)

Status: No longer recruiting

Protocol Number: WA16855

Sponsor: Roche Products Ltd.; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of MabThera retreatment on treatment response in patients with rheumatoid arthritis

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 studies WA16291 or WA17043. 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 470.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: rituximab[MabThera/Rituxan]

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

Key Secondary Outcomes: 1. Efficacy: Time to reach an ACR50 or 70 response; proportion of patients with a EULAR response, or a DAS28 response Safety: Adverse events, laboratory parameters

Inclusion Criteria:

  • adult patients, >=21 years of age, with active RA;
  • completed 24 weeks of treatment in WA16291 or WA17043;
  • eligible for re-treatment, based on clinical symptoms;
  • females of childbearing potential using reliable contraception.

Exclusion Criteria:

  • patients who participated in MabThera studies WA16291 or WA17043 but withdrew into the safety follow-up phases of these trials;
  • current treatment with any other disease-modifying drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
  • development of any new contraindications to receiving MabThera;
  • female patients who are pregnant or breastfeeding.

Gender: Males or Females

Age Limits: Min: 21 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2002

Trial Registration Date: 07/26/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Peoria, AZ 85381
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 1:50:39 PM


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