An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01564901
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- Adults patients, over 18 years of age
- Patients with moderate to severe rheumatoid arthritis (RA)
- Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion
Exclusion Criteria
- Patients previously treated with RoActemra/Actemra
- Any contraindication to RoActemra/Actemra
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day Week 36
- Secondary Outcome Measures
Name Time Method Change from baseline in glucocorticoid dose Week 36 Change from baseline in corticosteroid dose Week 36 Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose Week 36 Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids Week 36 Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use Week 36 Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day Week 36 Percentage change in Disease Activity Score 28 (DAS28) Week 36 Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day Week 36 Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction Week 36 Percentage change in Simplified Disease Activity Index (SDAI) score Week 36 Safety: Incidence of adverse events 36 weeks