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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01615419

ML28259

Details and patient eligibility

About

This multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

Enrollment: 60 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 the revised ACR criteria
• Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision

Exclusion criteria

• RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit
• 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 investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
• History of autoimmune disease or of any joint inflammatory disease other than RA

Trial design

60 participants in 1 patient group

Cohort