Trial Information

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

Status: No longer recruiting

Protocol Number: WA17043

Sponsor: Roche Products Ltd.; Genentech Inc.

Company Division: Pharmaceutical

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

Brief Summary: This study will assess the efficacy and safety of different treatment regimens of MabThera, corticosteroids and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA). The anticipated time on study treatment is up to 2 years, with repeat treatments provided under protocol WA16855, and the target sample size is 100-500 individuals. Target sample size is 440.

Study Phase: II

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. Efficacy:Proportion of patients with an ACR20 response at Week 24

Key Secondary Outcomes: 1. Efficacy: Proportion of patients with ACR(50,70) responses at Wk 24, Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups Safety: Adverse events, laboratory parameters

Inclusion Criteria:

  • adult patients 18-80 years of age with active RA for >=6 months;
  • inadequate response or intolerance to treatment with 1-5 disease modifying antirheumatic drugs (DMARDs) or biologics, other than MTX;
  • receipt of MTX for >=12 weeks, with the last 4 weeks at a stable dose;
  • active RA including at least 8 active joints and elevated acute phase reactants;
  • patients of reproductive potential must be using reliable contraceptive methods.

Exclusion Criteria:

  • functional RA Class IV;
  • previous treatment with MabThera or other cell-depleting therapies;
  • concurrent treatment with any DMARD (other than MTX) or any anti-tumor necrosis factor or other biologic therapy;
  • history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
  • known contraindications to receiving MabThera;
  • known bacterial, viral, fungal, mycobacterial or other infection;
  • women who are pregnant or breastfeeding.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 80 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 2003

Trial Registration Date: 07/26/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Perth, Australia, 6000
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: August 20, 2008 at 2:11:58 PM


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