A Survey of Darvadstrocel in People With Crohn's Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Darvadstrocel: Darvadstrocel injection

Study 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

Primary outcome measure(s)

• Number of Participants with Adverse Events — 36 Months
  An adverse event is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product (including an investigational product for a new indication in Japan), whether or not related to the pharmaceutical product.
• Percentage of Participants who Achieve Clinical Response — Baseline, Up to Months 36
  Clinical Response is defined as the clinically confirmed closure of at least 50% of the fistulas with this product as compared to baseline that were not drained with gentle finger compression.
• Percentage of Participants who Achieve Clinical Remission — Baseline, Up to Months 36
  Clinical remission is defined as the clinically confirmed closure of all fistulas treated with this product as compared to baseline with no discharge despite gentle finger compression.
• Percentage of Participants who Achieve Combined Remission — Baseline, Up to Months 36
  Combined remission is defined as the clinically confirmed closure of all baseline external openings that were not drained by gentle finger compression with this product treatment, and absence of an abscess greater than or equal to 2 cm in size confirmed by pelvic MRI (if performed) performed within 6 months of this product treatment.

Trial sites (1)

More Takeda trials in Japan

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