Trial Information

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

Status: No longer recruiting

Protocol Number: WA17047

Sponsor: F Hoffman-La Roche Ltd; Genentech Inc.

Company Division: Pharmaceutical

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

Brief Summary: This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis, naive to methotrexate. Patients will be randomized to receive MabThera or placebo, and all patients will receive concomitant methotrexate, 7.5-20mg orally, once weekly. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 750.

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. Change in total modified Sharp score at week 52

Key Secondary Outcomes: 1. Efficacy: Modified total Sharp score at wks 24 and 104,and Sharp erosion and JSN score at wk 52. % of patients without radiographic progression, and with ACR20/50/70/90, DAS28 at wk 52. HAQ-D1 and SF-36 at wks 52 and 104. Safety:AEs, lab parameters

Inclusion Criteria:

  • adult patients 18-80 years of age;
  • RA for >=2 months;
  • receiving outpatient treatment;
  • patients naive to, and considered to be candidates for, methotrexate treatment.

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;
  • concurrent treatment with any biologic agent or DMARD other than methotrexate.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 80 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2006

Trial Registration Date: 03/10/2006

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Shenton Park, Australia, 6008
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 1:52:41 PM


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