NCT01564901已完成不适用
A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients previously treated with RoActemra/Actemra
- •Any contraindication to RoActemra/Actemra
结局指标
主要结局
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day
时间窗: Week 36
次要结局
- 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)
- Change from baseline in glucocorticoid dose(Week 36)
- Change from baseline in corticosteroid dose(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)
研究者
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