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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Clalit Health Services

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Moderate to severe rheumatoid arthritis

• Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent

• Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

• RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit

• Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use

• Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra

• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis