An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01543503

MA27950

Details and patient eligibility

About

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

Enrollment: 1,225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/=18 years of age
• Diagnosis of rheumatoid arthritis
• Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
• Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed

Exclusion criteria

• Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
• Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
• Patients whose first biologic is rituximab, abatacept or anakinra.
• Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit

Trial design

1,225 participants in 1 patient group

Cohort