A Survey of Darvadstrocel in People With Crohn's Disease
J-INSPIRE
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)
2 other identifiers
observational
275
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedStudy Start
First participant enrolled
November 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
November 17, 2025
November 1, 2025
8.1 years
November 5, 2021
November 13, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants with Adverse Events
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.
36 Months
Percentage of Participants who Achieve Clinical Response
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.
Baseline, Up to Months 36
Percentage of Participants who Achieve Clinical Remission
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.
Baseline, Up to Months 36
Percentage of Participants who Achieve Combined Remission
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.
Baseline, Up to Months 36
Secondary Outcomes (6)
Percentage of Participants who Occurred Recurrence of Previously Treated Anal Fistulas in Participants who Achieved Clinical Remission at the Previous Visit
Baseline, Up to Months 36
Percentage of Participants with New Perianal Abscess in a Previously Treated Anal Fistula
Baseline, Up to Months 36
Change from Baseline in Perianal Disease Activity Index (PDAI)
Baseline, Up to Months 36
Change from Baseline in Harvey Bradshaw Index (HBI: Simple CDAI Score)
Baseline, Up to Months 36
Health-Related Quality of Life (HRQOL) Measured by EuroQoL Five Dimensions Five Levels (EQ-5D-5L) Scale
Baseline, Up to Months 36
- +1 more secondary outcomes
Study Arms (1)
Darvadstrocel
Darvadstrocel, 24 mL suspension of 120 million cells as a perilesional injection, once. Participants received interventions as part of routine medical care.
Interventions
Eligibility Criteria
All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda selected site
Tokyo, Tokyo, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2021
First Posted
November 9, 2021
Study Start
November 30, 2021
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.