Comparison of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 678
- 试验地点
- 116
- 主要终点
- Retention Rate of UPA vs TNFi
研究概览
简要总结
This study will compare the retention rates for UPA vs. TNFi treatment in adult participants with moderate to severe active RA per local label and according to local standard of care
This is a mono-country, prospective, multi-center observational study in patients with moderate to severe active RA receiving UPA or TNFi therapy. Around 678 participants will be enrolled in approximately 80 sites in Germany.
Study recruitment will last approximately 24 months, and the study participation time will be up to 24 months, for a total study duration of approximately 48 months.
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
- •Current or Past participants with a confirmed diagnosis of moderate to severe active RA upon judgement of the treating physician.
- •Physician decision on participant treatment with Upadacitinib (UPA) or tumor necrosis factor inhibitor (TNFi) must have been reached prior to and independently of recruitment in the study
- •UPA or TNFi prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies
排除标准
- •Participation in a clinical trial with an investigational drug (within a minimum of 30 days or 5 half-lives of the investigational drug [whichever is longer] prior to baseline)
- •Prior treatment with Upadacitinib
- •Prior treatment with the same tumor necrosis factor inhibitor as the one prescribed for this study
研究组 & 干预措施
Tumor Necrosis Factor Inhibitor-Treatment
Participants will receive a tumor necrosis factor inhibitor treatment as prescribed by their physician according to local label.
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.
结局指标
主要结局
Retention Rate of UPA vs TNFi
时间窗: Up to approximately 24 months
Time to the discontinuation of Upadacitinib. Time to the discontinuation of Tumor Necrosis Factor Inhibitor treatment
次要结局
未报告次要终点