Trial Information

Summary: A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Status: No longer recruiting

Protocol Number: WA17824

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe active rheumatoid arthritis

Brief Summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. Target sample size is 673.

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: tocilizumab

Primary Outcome: 1. Percentage of patients with ACR 20 response Time frame: Week 24

Key Secondary Outcomes: 1. Percentage of patients with ACR 20 response Time frame: Week 8 2. Percentage of patients with ACR 50 and ACR 70 responses Time frame: Week 24 3. Mean change in parameters of ACR core set Time frame: Week 24 4. AEs, laboratory parameters, vital signs. Time frame: Throughout study

Inclusion Criteria:

  • adult patients at least 18 years of age with active RA for at least 3 months;
  • patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

  • major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
  • treatment with methotrexate (MTX) within 6 months of entering study;
  • patients who have stopped previous MTX treatment due to toxicity or lack of response;
  • women who are pregnant or breast-feeding.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2005

Trial Registration Date: 07/26/2005

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

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

  

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Trial listings updated: May 13, 2008 at 1:49:44 PM


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