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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01565122

ML28207

Details and patient eligibility

About

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Moderate to severe rheumatoid arthritis
• Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

Exclusion criteria

• RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
• Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
• 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

Trial design

51 participants in 1 patient group

Cohort