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

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: methotrexate

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00754572

ML21530

Details and patient eligibility

About

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.

Enrollment

418 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.