A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01921478
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
- Adult patients, >=18 years of age
- Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1
- Inadequate responder to at least 2 non-biological DMARDs
- Absence of documented erosions at start of RoActemra/Actemra treatment
- Received RoActemra/Actemra treatment for at least 6 months
- Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit
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Exclusion Criteria
- Contraindications for treatment with RoActemra/Actemra
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Joint erosion assessment in clinical practice 6 months
- Secondary Outcome Measures
Name Time Method Tender joint counts 6 months Disease Activity Score 28 6 months Patient's global assessment of disease activity (Visual Analogue Scale) 6 months C-reactive protein assessment 6 months Swollen joint counts 6 months Erythrocyte Sedimentation Rate 6 months Evolution of the pattern of joint erosion 6 months