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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• patients >=18 years with moderate to severe active RA for at least 6 months;

• swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;

• inadequate response to stable dose of MTX;

• patients of reproductive potential must be using a reliable means of contraception.

Exclusion Criteria:

• rheumatic autoimmune disease other than RA;

• patients with functional class IV RA;

• diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;

• prior treatment failure with anti-tumor necrosis factor agent;

• pregnant or breastfeeding women.