An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01394276

ML25728

Details and patient eligibility

About

This observational study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected from patients for the 12 months following the first infusion of RoActemra/Actemra.

Enrollment: 322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria
• Initiated on RoActemra/Actemra treatment according to the Summary of Product Characteristics not more than 6 months before opening of study center

Exclusion criteria

• Current serious infection
• Hypersensitivity to the active component or any of the excipients
• Pregnant women

Trial design

322 participants in 1 patient group

Tocilizumab

Description:

Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra \[Tocilizumab (TCZ)\] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).