Trial Information

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

Status: No longer recruiting

Protocol Number: WA17045

Sponsor: Roche Products Ltd / Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study to evaluate the effect on treatment response of MabThera in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis

Brief Summary: This study will evaluate the efficacy and safety of MabThera in patients with RA. Patients will be randomized to receive MabThera or placebo, and all patients will receive concomitant methotrexate, 10-25 mg 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 500.

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: 1. Proportion of patients with ACR20 response at Week 24.

Key Secondary Outcomes: 1. Efficacy: Proportion of patients with ACR50 and ACR70 response at Week 24; change in DAS28, ACR core set, SF36, and FACIT-F fatigue assessment from baseline to Week 24. EULAR response rates at Week 24. Safety: AEs,, lab parameters.

Inclusion Criteria:

  • adult patients 18-80 years of age;
  • RA for >=6 months;
  • receiving outpatient treatment;
  • inadequate response to methotrexate, having received and tolerated it for >=12 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 rheumatoid arthritis, or RA before the age of 16;
  • surgery within 12 weeks of study;
  • previous treatment with any approved or investigational biologic agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 80 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2005

Trial Registration Date: 03/10/2006

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Birmingham, AL 35294
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: July 21, 2008 at 2:16:29 PM


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