A Survey of Darvadstrocel in People With Crohn's Disease (J-INSPIRE)

Takeda

Status: Enrolling

Conditions: Crohn's Disease

Treatments: Biological: Darvadstrocel

Study type: Observational

Funder types: Industry

Identifiers

NCT05113095

jRCT2033210424 (Registry Identifier)

Alofisel-5008

Details and patient eligibility

About

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.

Enrollment: 275 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.

Exclusion Criteria None

Trial design

275 participants in 1 patient group

Darvadstrocel

Description:

Darvadstrocel, 24 mL suspension of 120 million cells as a perilesional injection, once. Participants received interventions as part of routine medical care.

Treatment:

Biological: Darvadstrocel