A Non-Interventional Study in Rheumatoid Arthritis Patients Treated With Tocilizumab (RoActemra/Actemra)

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01613378

ML28121

Details and patient eligibility

About

This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria
• Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph
• Informed consent to data being subject to computerized data processing
• Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage

Exclusion criteria

• Received tocilizumab prior to enrolment visit
• Previously received tocilizumab in a clinical trial or for compassionate use
• Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab
• Participation in another clinical trial or industry sponsored observational study
• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome

Trial design

200 participants in 1 patient group

Rheumatoid Arthritis Cohort

Description:

The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.

Treatment:

Other: No intervention