Crohn'sRecruiting
A Survey of Darvadstrocel in People With Crohn's Disease
Observational · No treatment assigned · 1 site · Takeda
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 20 and older
- Any sex
Some of the main requirements, copied from the record:
- See the official record.
Only the trial team can confirm whether you qualify.
What's involved
- About 275 participants are expected to take part.
- Start date: 2021-11-30.
- Main results expected around 2029-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Japan.
Main thing being measured
- Number of Participants with Adverse Events (36 Months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn's Disease |
| Lead sponsor | Takeda |
| Enrollment | 275 (estimated) |
| Start date | 2021-11-30 |
| Primary completion (est.) | 2029-12-31 |
| First posted | 2021-11-09 |
| Last updated | 2025-11-17 |
| 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) |
| ClinicalTrials.gov ID | NCT05113095 |
Interventions
- Darvadstrocel (Biological)
Darvadstrocel injection
Full eligibility criteria (from the record)
Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included. Exclusion Criteria None
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Takeda selected site | Tokyo, Tokyo | Japan | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.