A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01649817
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline
- RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
- Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis
Exclusion Criteria
- Rheumatic autoimmune disease other than RA
- Participation in interventional clinical trials during the observational period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment 12 months
- Secondary Outcome Measures
Name Time Method Frequency of withdrawal (according to reasons) 12 months Frequency of dose modifications 12 months Change in disease activity (DAS28) from baseline to Month 6 or withdrawal, whichever comes first