Trial Information

Summary: A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

Status: No longer recruiting

Protocol Number: WA17044

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study to evaluate the effect of various re-treatment regimens of MabThera in combination with methotrexate on treatment response in rheumatoid arthritis patients with an inadequate response to methotrexate.

Brief Summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 375.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: rituximab [MabThera/Rituxan]

Primary Outcome: Percentage of patients with an ACR 20 response. Timeframe: Week 48.

Key Secondary Outcomes: Proportion of patients with ACR 50 & ACR 70. Timeframe: Week 48. Change in DAS28, SF-36, FACIT-Fatigue assessment from baseline. Timeframe: Week 48. EULAR response rates. Timeframe: Week 48. AEs, laboratory parameters, & acute phase reactants. Timeframe: Throughout study.

Inclusion Criteria:

  • adult patients >=18 years of age;
  • RA for >=6 months;
  • receiving outpatient treatment;
  • inadequate response to methotrexate, having received and tolerated it for >=12 weeks, with a stable dose for >=4 weeks.

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
  • inflammatory joint disease other than RA, or other systemic autoimmune disorder;
  • diagnosis of juvenile arthritis, or RA before the age of 16;
  • previous treatment with >1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2006

Trial Registration Date: 03/10/2006

Date Last Updated: 02/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Coffs Harbour, Australia, 2450
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 1:48:57 PM


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