Early therapeUtic RespOnse and Predictivity of Long-term Effectiveness of Upadacitinib in Ulcerative Colitis (EUROPE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 150
- 主要终点
- Percentage of participants achieving symptomatic remission per partial adapted Mayo score among those who achieved clinical response and/or intestinal ultrasound (IUS) response at week 8 of upadacitinib (UPA) induction
研究概览
简要总结
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will assess how effective upadacitinib is in treating UC.
Upadacitinib (RINVOQ) is an approved drug for treating UC. Approximately 400 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Germany, Austria and Switzerland.
Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 2 years.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.
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
- •Participants with an endoscopically confirmed diagnosis of active moderate to severe Ulcerative colitis (UC).
- •Participants initiating Upadacitinib (UPA) at the investigator's discretion as part of their routine clinical care; the decision to administer UPA must be made prior to and independent of documentation for the study and according to the approved local label.
- •Participants able to understand and communicate with the investigator and comply with the requirements of the study.
- •Participants willing to continue with study documentation after cessation of UPA.
排除标准
- •Participants with any contraindication to Upadacitinib (UPA).
- •Participants previously exposed to a Janus kinase (JAK) inhibitor.
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 achieving symptomatic remission per partial adapted Mayo score among those who achieved clinical response and/or intestinal ultrasound (IUS) response at week 8 of upadacitinib (UPA) induction
时间窗: Week 52
Symptomatic remission per partial adapted Mayo score is defined as stool frequency (SF)=0/1 and rectal bleeding score (RBS) =0.
次要结局
未报告次要终点