NCT05113095

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 275 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Darvadstrocel	Darvadstrocel injection

Timeline

• Start date: 2021-11-30
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2021-11-09
• Last updated: 2025-11-17

Locations

1 site across 1 country: Japan