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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01705730

ML28269

Details and patient eligibility

About

This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants, >/= 18 years of age
• Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
• Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
• Concomitant treatment with NSAIDs and/or corticosteroids is allowed

Exclusion criteria

• Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
• Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
• Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
• Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
• Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Trial design

71 participants in 1 patient group

Tocilizumab

Description:

Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.

Treatment:

Drug: tocilizumab