Clinical trial Recruiting at 1 site Observational Ages 20 and up

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 typeObservational
Ages20 Years and up
SexAll
Enrollment275 (estimated)
SponsorTakeda
Industry-sponsored
Locations1 site (Tokyo, Tokyo)
StatusRecruiting
StartedNovember 30, 2021
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedNovember 17, 2025
Trial IDNCT05113095 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.