Casting Light on Urgency and Effectiveness of Advanced Therapies in Ulcerative Colitis in Japan (CLUES-UC-J)

Kitasato University Kitasato Institute Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2025年5月23日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Kitasato University Kitasato Institute Hospital
入组人数: 60
主要终点: Proportion of participants who meet criteria for symptomatic remission

暂无简介。

•Participant who have given their written consent to participate in this study.
•Participant must be 18 years or older.
•Confirmed by investigator to have a diagnosis of moderately to severely active UC.
•Participant who were previously untreated or failed treatment with biologics.*
•Initiating or planning to initiate mirikizumab for UC in the next 60 days of treatment decision
•Biologic failure is in the opinion of the investigator. If a participant failed a biologic and its biosimilar, it is counted as 1 biologic failure.

•Have a current diagnosis of Crohn's disease.
•Current or planned participation in an interventional clinical trial for UC.
•Cognitive incapacity and language barriers precluding adequate understanding or cooperation.
•Employees of the institution to which the investigator and co-investigator belong and their family members. Family members are defined as the spouse, biological parents, relatives, siblings, and children of the investigator or co-investigator's institutional affiliate.
•Any other conditions that the investigator deems inappropriate for the study.

Proportion of participants who meet criteria for symptomatic remission

时间窗: 52 weeks

Proportion of participants who meet criteria for symptomatic remission after 52 weeks of therapy with mirikizumab

未报告次要终点

发起方