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

• Proportion of patients with ACR20/70 responses; change from baseline in ACR core set components; change in disease activity score (DAS28); categorical DAS28 responders; Quality of Life assessments. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
• Adverse events, clinical laboratory tests, physical exam including vital signs. [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]

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

• Drug: tocilizumab [RoActemra/Actemra]
  8mg/kg iv, every 4 weeks
• Drug: methotrexate
  10-25mg oral or parenteral weekly.

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.