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

Hoffmann-La Roche0 sites1,220 target enrollmentApril 2005

ConditionsRheumatoid Arthritis

Interventionstocilizumab [RoActemra/Actemra]Placebo

DrugsPlacebo tocilizumab [RoActemra/Actemra]

Overview

Phase: Phase 3
Intervention: tocilizumab [RoActemra/Actemra]
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 1220
Primary Endpoint: Percentage of patients with ACR 20 response
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

December 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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.