A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

• Proportion of patients with ACR50 and ACR70 responses; change from baseline in DAS28; proportion of patients with DAS28<2.6;QOL scores (HAQ-DI and FACIT) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
• Time to onset of ACR20/50/70 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
• Adverse events [ Time Frame: At each visit to week 24 ] [ 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 patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8mg/kg iv every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• adult patients,>=18 years of age;
• rheumatoid arthritis diagnosed >8 weeks and <4 years prior to baseline;
• naive to, or not responding well to, methotrexate;
• swollen joint count >=8 (66 joint count) and tender joint count>=8 (68 joint count) at screening and baseline.

Exclusion Criteria:

• rheumatic autoimmune disease other than rheumatoid arthritis;
• patients with functional class IV rheumatoid arthritis;
• history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.