Trial Information

Summary: A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Status: No longer recruiting

Protocol Number: WA18063

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of tocilizumab on reduction in signs and symptoms in patients with moderate to severe active rheumatoid arthritis and inadequate response to DMARD therapy

Brief Summary: This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 1205.

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: tocilizumab

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

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

Inclusion Criteria:

  • patients at least 18 years of age with moderate to severe active RA for at least 6 months;
  • inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
  • stable DMARD therapy for at least 8 weeks before entering study;
  • 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 surgery within 6 months after entering study;
  • patients who have previously failed treatment with an anti-tumor necrosis factor agent;
  • women who are pregnant or breast-feeding.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: April, 2005

Trial Registration Date: 07/26/2005

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Sydney, Australia, 2077
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 1:42:11 PM


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