An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01338545

ML25264

Details and patient eligibility

About

This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Moderate to severe rheumatoid arthritis (RA) of at least 6 months duration
• Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment
• Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications

Exclusion criteria

• History of autoimmune disease or of any joint inflammatory disease other than RA
• Pregnant or lactating women
• Patients who have started RoActemra treatment in a clinical trial or for compassionate use
• Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)

Trial design

400 participants in 1 patient group

Cohort