A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 104
- 主要终点
- Percentage of Participants with Drug Related Serious Infections
研究概览
简要总结
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.
Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 participants will be enrolled in Japan.
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 64 weeks.
There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with moderately to severely active Crohn's disease (CD).
- •Has been prescribed upadacitinib for CD as per most current local approved label after its approval for CD in Japan.
- •Within 14 days from the commencement of upadacitinib induction treatment for CD at the participating institution.
排除标准
- •Currently participating in another interventional clinical research.
- •Participants for whom upadacitinib is contraindicated.
- •Has been treated with upadacitinib for CD before and continue treatment with upadacitinib for CD at the participation to this study.
研究组 & 干预措施
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.
结局指标
主要结局
Percentage of Participants with Drug Related Serious Infections
时间窗: Up to 64 Weeks
Pecentage of participants with serious infections.
次要结局
未报告次要终点