Trial Information

Summary: A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis

Status: No longer recruiting

Protocol Number: WA17823

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of safety and prevention of structural joint damage during treatment with tocilizumab versus placebo, in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis

Brief Summary: This 3 arm study will compare the safety and efficacy, with respect to prevention of joint damage, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4mg iv, tocilizumab 8mg iv or placebo iv, every 4 weeks. All patients will also receive methotrexate, 10-25mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. Target sample size is 1170.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: tocilizumab

Primary Outcome: 1. Percentage of patients with ACR 20 response Time frame: Week 24 2. Change in modified Sharp total radiographic score and physical function Time frame: Week 52 and 104

Key Secondary Outcomes: 1. Percentage of patients with ACR 20/50/70 responses. Time frame: Week 24 2. Percentage of patients with ACR 70 maintained for 6 months Time frame: Week 24 3. Mean changes in parameters of ACR core set Time frame: Week 24 4. AEs, laboratory parameters, vital signs. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2005

Trial Registration Date: 07/26/2005

Date Last Updated: 07/15/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: August 11, 2008 at 2:00:33 PM