Survey of Darvadstrocel for treating Crohn's disease
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)
Run by Takeda · NCT05113095 · Data updated 2026-11-12
This study looks at how well Darvadstrocel injections work for people with Crohn's disease and complicated anal fistulas in Japan, while also keeping track of any side effects over three years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 275 (estimated) |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Tokyo, Tokyo) |
| Status | Recruiting |
| Started | November 30, 2021 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT05113095 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with Crohn's disease who have complex perianal fistulas and are receiving Darvadstrocel injections.
✕Probably not a fit
Patients without complex perianal fistulas or those not receiving Darvadstrocel will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study surveys the use of Darvadstrocel injections in patients with Crohn's disease who have complicated anal fistulas. Conducted in Japan, the study aims to monitor side effects and assess symptom improvement over a period of 36 months. Participants will receive Darvadstrocel according to their clinic's standard practices, while the study sponsor will provide guidelines for data collection. The focus is on real-world outcomes rather than controlled treatment conditions.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and effectiveness of Darvadstrocel for managing Crohn's disease symptoms.
How similar studies have gone: While this approach is observational, similar studies have shown promise in evaluating treatment outcomes for Crohn's disease.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included. Exclusion Criteria None
Where it's running
-
Takeda selected site
Tokyo, Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.