Trial Information

Summary: A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis.

Status: Recruiting

Protocol Number: ML21136

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double blind, parallel group study to evaluate the effect of tocilizumab versus placebo in reducing the signs and symptoms of rheumatoid arthritis in combination with DMARDs in patients with moderate to severe active rheumatoid arthritis

Brief Summary: This 2 arm study will assess the safety and efficacy, with regard to reduction in signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with moderate to severe active rheumatoid arthritis, with an inadequate response to DMARDs. Patients will be randomized in a ratio of 2:1 to receive either tocilizumab 8mg/kg iv or placebo iv every 4 weeks; all patients will also receive stable antirheumatic therapy including permitted DMARDs. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 570.

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. Number and percentage of patients with ACR 50 response Time frame: Week 24

Key Secondary Outcomes: 1. Number and percentage of patients with ACR 20/50/70, and mean change from baseline in DAS 28, RAPID, SF-12, FACIT-F, MOS sleep scale. Time frame: Week 24 2. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 09/17/2007

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 3:20:18 PM