RecruitingNCT05113095

A Survey of Darvadstrocel in People With Crohn's Disease

Postmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocel for the Treatment of Complex Perianal Fistulas in Crohn's Disease Patients (J-INSPIRE) (All-case Surveillance)


Sponsor

Takeda

Enrollment

275 participants

Start Date

Nov 30, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Darvadstrocel injection and to check if Darvadstrocel injection improves symptoms of Crohn's disease. During the study, participants with Crohn's disease will take Darvadstrocel injection according to their clinic's standard practice. The study doctors will check for side effects from Darvadstrocel for 36 months.


Eligibility

Min Age: 20 Years

Interventions

BIOLOGICALDarvadstrocel

Darvadstrocel injection


Locations(1)

Takeda selected site

Tokyo, Tokyo, Japan

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NCT05113095


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