An Observational Study of Glucocorticoid Use in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab)
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01392001
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with \>5 mg prednisone or equivalent for at least 3 months .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 322
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Patients with rheumatoid arthritis for whom the rheumatologist decided to introduce RoActemra
- Patients taking more than 5 mg/day of oral prednisone (or equivalent) for at least 3 months
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Exclusion Criteria
- Participation in a clinical trial in rheumatoid arthritis
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra approximately 29 months
- Secondary Outcome Measures
Name Time Method Patient reported outcome: European League against Rheumatism - Rheumatoid Arthritis Impact of Disease score (EULAR-RAID)/Health Assessment Questionnaire - Disease Index (HAQ-DI) approximately 29 months Efficacy: Disease activity score (DAS 28) approximately 29 months Co-medications: dosage and treatment schedules approximately 29 months Safety: Incidence of adverse events approximately 29 months