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A Survey of Darvadstrocel in People With Crohn's Disease
Sponsor: Takeda
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.
Official title: 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)
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
OBSERVATIONAL
Enrollment
275
Start Date
2021-11-30
Completion Date
2029-12-31
Last Updated
2025-11-17
Healthy Volunteers
No
Conditions
Interventions
Darvadstrocel
Darvadstrocel injection
Locations (1)
Takeda selected site
Tokyo, Tokyo, Japan