A Survey of Darvadstrocel in People With Crohn's Disease (J-INSPIRE)
About this clinical trial
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.
At a glance
What medical conditions are being studied?
What is the clinical trial testing?
Darvadstrocel
How many participants are being enrolled?
275
Are placebos part of the clinical trial?
No
When is the clinical trial being conducted?
Nov 2021 - Dec 2029
Key requirements
Sexes
All
Age
20+ Years
Healthy volunteers?
No
Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who
received Darvadstrocel will be included.
Exclusion Criteria None