A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Takeda Development Center Americas, Inc0 个研究点目标入组 150 人开始时间: 2019年9月3日最近更新: 2024年4月22日

研究概览

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•Subject eligibility is determined according to the following criteria before entry into the study:
•1. In the opinion of the investigator, the subject is capable of understanding and complying withprotocol requirements.
•2. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written ICF and any required privacy authorization before the initiation of any study procedures.
•3. The subject has participated in and completed the ADMIRE-CD II study (ie, did not discontinue).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 124
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 26

•Subjects will not be eligible for inclusion in the study if:
•1. It has been more than 3 months since the subject completed the ADMIRE-CD II study.
•2. Subjects are currently receiving, have received any investigational drug in the last 3 months before the inclusion in the study, or are planning to receive any investigational drug during the duration of this LTE study, except for prior participation in the ADMIRE-CD II study.

发起方