A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01770834

ML25533

Details and patient eligibility

About

This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 21 years of age
• Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
• Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
• Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion criteria

• Pregnant or lactating women
• Contra-indication to RoActemra/Actemra treatment according to the local labelling
• Previous treatment with tocilizumab
• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
• Women of childbearing potential not using effective methods of contraception as defined by protocol

Trial design

100 participants in 1 patient group

Cohort