Trial Information

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

Status: No longer recruiting

Protocol Number: WA17042

Sponsor: Roche Products Ltd.; IDEC Pharmaceuticals Corporation

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 and inadequate response to methotrexate and anti-TNFa therapy

Brief Summary: This study will compare the safety and efficacy of MabThera and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who have had an inadequate response to anti-tumor necrosis factor-alpha (anti-TNF@) therapy. The anticipated time on study treatment is up to 2 years, with repeat treatments provided under protocol WA17531, 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: Placebo
  • 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 Week 24, Change in DAS from screening to Week 24, Categorical DAS responders at Week 24, Changes from screening in ACR core set and SF-36 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 anti-TNF therapies;
  • 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 disease-modifying antirheumatic drug (except for MTX) or any anti-TNFalfa factor or other biologic therapy;
  • history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
  • known contraindications to receiving MabThera;
  • known active bacterial, viral, fungal, mycobacterial or other infection;
  • women who are pregnant or breast-feeding.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 80 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2003

Trial Registration Date: 07/26/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Phoenix, AZ 85032
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 1:48:18 PM


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