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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01669902

ML28247

Details and patient eligibility

About

This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for 6 months.

Enrollment: 107 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 (1987) ACR criteria
• Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included
• Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed

Exclusion criteria

• Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit
• Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
• Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
• Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment
• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Trial design

107 participants in 1 patient group

Cohort