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A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:
A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis

Clinical Trial Summary

This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is <500 individuals.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00754572
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 3
Start date February 2009
Completion date October 2012
View Details
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