A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 22
- 主要终点
- Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28
研究概览
简要总结
This prospective, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks after starting treatment with tocilizumab. All visits and assessments will be performed as per routine clinical practice, with no study-specific visits or interventions.
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
- •Diagnosis of moderate to severe RA, defined as DAS28 greater than or equal to 3.7
- •Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment
- •Physician has made decision to commence IV or SC tocilizumab in accordance with label and reimbursement criteria
- •Treated with glucocorticoids for RA when starting tocilizumab treatment
排除标准
- •Treatment with any investigational agent within 4 weeks or 5 half-lives before tocilizumab
- •Continuous or regular treatment with oral corticosteroids for any indication other than RA
研究组 & 干预措施
Glucocorticoids + Tocilizumab
Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.
干预措施: Tocilizumab (Drug)
Glucocorticoids + Tocilizumab
Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.
干预措施: Glucocorticoid Agent (Drug)
结局指标
主要结局
Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28
时间窗: Week 52
Percentage of Participants by Reason for Glucocorticoid Dose Modification
时间窗: Baseline up to Week 52
Percentage of Participants Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28)
时间窗: Week 52
次要结局
- Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%(Weeks 24 and 52)
- Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids(Baseline up to Week 52)
- Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%(Baseline up to Week 52)
- Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids(Baseline up to Week 52)
- Glucocorticoid Dose among Participants in Remission According to DAS28(Baseline up to Week 52)
- Correlation between DAS28 Score and Glucocorticoid Dose(Baseline up to Week 52)
- Glucocorticoid Dose(Baseline; Weeks 24 and 52)
- Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%(Weeks 24 and 52)
- Time to First Glucocorticoid Dose Reduction(Baseline up to Week 52)
- Time to Glucocorticoid Discontinuation(Baseline up to Week 52)
- Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction(Baseline up to Week 52)
- Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%(Baseline up to Week 52)
- Percentage of Participants with Adverse Events(Baseline up to Week 52)
- Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction(Baseline up to Week 52)
- Glucocorticoid Dose among Participants with LDA According to DAS28(Baseline up to Week 52)