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)

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Darvadstrocel

• Study Type: Observational
• Enrollment (Estimated): 275

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Japan
  • Tokyo
    • Tokyo, Tokyo, Japan
      • Recruiting
      • Takeda Selected Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Exclusion Criteria None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Darvadstrocel; Darvadstrocel, 24 mL suspension of 120 million cells as a perilesional injection, once. Participants received interventions as part of routine medical care.	Biological: Darvadstrocel; Darvadstrocel injection; Other Names: Cx601

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Occurred Recurrence of Previously Treated Anal Fistulas in Participants who Achieved Clinical Remission at the Previous Visit	Recurrence of previously treated anal fistulas in patients who achieved clinical remission at the previous visit is defined as clinically confirmed recurrence with expulsion in any of the external openings treated with this product or the presence of a 2-axis or larger abscess > 2 cm in a previously treated fistula confirmed by MRI scan (if performed).	Baseline, Up to Months 36
Percentage of Participants with New Perianal Abscess in a Previously Treated Anal Fistula	New perianal abscess in a previously treated anal fistula is defined as fluid collection with a margin enhancing effect such that a high signal on T2-weighted image and a high signal edge on Gadolinium-enhanced T1-weighted image of the pelvis at the site of administration of this product, if performed. A new perianal abscess will be reported as an adverse event and the investigator will determine the causality with this product treatment.	Baseline, Up to Months 36
Change from Baseline in Perianal Disease Activity Index (PDAI)	The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) Discharge; (b) Pain; (c) Restriction of sexual activity; (d) Type of perianal disease; and (e) Degree of induration. The discharge item is graded on a 5-point scale where 0 indicates no symptoms and 4 indicates severe symptoms and total range of score is from 0 to 4. Higher score means more severe disease. Negative change from Baseline indicates improvement.	Baseline, Up to Months 36
Change from Baseline in Harvey Bradshaw Index (HBI: Simple CDAI Score)	The HBI is a physician-reported index consisting of five clinical manifestations of CD. HBI items include performance status, abdominal pain, number of watery stools per day, abdominal mass, and complications. The HBI is a cumulative scoring system with the following threshold for lesion activity: Remission (< 5), mild (5 ~ 7), moderate (8 ~ 16), severe (> 16). Higher score means more severe disease. Negative change from Baseline indicates improvement.	Baseline, Up to Months 36
Health-Related Quality of Life (HRQOL) Measured by EuroQoL Five Dimensions Five Levels (EQ-5D-5L) Scale	EQ-5D-5L is a self-administered preference-based measure of health status suitable for calculating quality-adjusted life-years (QALYs) to inform economic evaluations. EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (no problems, slight problems, moderate problems, severe problems, and extreme problems). Scores ranges from best (100) to worst (0).	Baseline, Up to Months 36
HRQOL Measured by Crohn's Anal Fistula Quality of Life (CAF-QoL) Scale	CAF-QoL scale is a measure to check QOL related to Crohn's anal fistula. CAF-QoL scale includes 28-item questionnaires in 3 categories (symptoms of anal fistula, influence of treatment for anal fistula, and quality of life), and 5 response levels for each domain and each score (Not at all: 0, Rarely applicable: 1, Neither: 2, Almost Applicable: 3, Very Much Applicable: 4) for 27-item questionnaires and text format for remaining 1 questionnaire. Scores ranges from best (0) to worst (104).	Baseline, Up to Months 36

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: Alofisel-5008; jRCT2033210424 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No