A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01770834
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 3 years
- Secondary Outcome Measures
Name Time Method Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6) approximately 3 years Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment approximately 3 years Treatment regimens: Concomitant medications approximately 3 years