Survey of Darvadstrocel for treating 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)
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 |
|---|---|
| Enrollment | 275 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Tokyo, Tokyo) |
| Trial ID | NCT05113095 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with Crohn's disease who have complex perianal fistulas and are receiving Darvadstrocel injections.
Not a fit: Patients without complex perianal fistulas or those not receiving Darvadstrocel will not benefit from this study.
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 performed: While this approach is observational, similar studies have shown promise in evaluating treatment outcomes for Crohn's disease.
Eligibility criteria
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 this trial is running
Tokyo, Tokyo
- Takeda selected site — Tokyo, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.