RecruitingNCT05113095

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)


Sponsor

Takeda

Enrollment

275 participants

Start Date

Nov 30, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This is a survey study — not a treatment trial — looking at how well a medication called darvadstrocel (also known as Alofisel) works in real-world patients with Crohn's disease who have complex anal fistulas. Anal fistulas in Crohn's disease are abnormal tunnels between the gut and skin near the anus that can be very difficult to treat. Darvadstrocel is a cell-based therapy already approved in some countries for this condition, and this study collects data on outcomes after its use. **You may be eligible if...** - You have Crohn's disease with complex perianal (around the anus) fistulas - You have already received or are receiving darvadstrocel treatment - You are willing to participate and provide consent **You may NOT be eligible if...** - There are no formal exclusion criteria for this observational study This is a data collection study and does not involve any experimental treatments. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDarvadstrocel

Darvadstrocel injection


Locations(1)

Takeda selected site

Tokyo, Tokyo, Japan

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NCT05113095


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