Crohn's DiseaseJ-INSPIRENCT05113095
A Survey of Darvadstrocel in People With Crohn's Disease
An observational study of Crohn's Disease, run by Takeda at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Darvadstrocel
- Type of treatment
- Injection or infusion
- How many people
- 275 participants
- Where
- 1 siteJapan
- Study dates
- 30 Nov 2021to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.
Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.
Exclusion Criteria None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Crohn's Disease
- Being tested
- Darvadstrocel
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarvadstrocelBiological
Also called Cx601
Darvadstrocel injection
| Study group | Role | What they receive |
|---|---|---|
| Darvadstrocel | Darvadstrocel, 24 mL suspension of 120 million cells as a perilesional injection, once. Participants received interventions as part of routine medical care. Receives: Biological: Darvadstrocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline, Up to Months 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start30 Nov 2021
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113095
- Sponsor's protocol ID
- Alofisel-5008
- Other IDs
- jRCT2033210424
- Acronym
- J-INSPIRE
- Status last verified
- Nov 2025
- First submitted
- 5 Nov 2021
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05113095
- Acronym / sponsor ID
- J-INSPIRE / Alofisel-5008
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darvadstrocel | – | Biological: DarvadstrocelDarvadstrocel, 24 mL suspension of 120 million cells as a perilesional injection, once. Participants received interventions as part of routine medical care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarvadstrocelAlso: Cx601Darvadstrocel injection | Biological | Darvadstrocel |
Primary outcome
Number of Participants with Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Percentage of Participants who Occurred Recurrence of Previously Treated Anal Fistulas in Participants who Achieved Clinical Remission at the Previous Visit
Time frame: Baseline, Up to Months 36
Percentage of Participants with New Perianal Abscess in a Previously Treated Anal Fistula
Time frame: Baseline, Up to Months 36
Change from Baseline in Perianal Disease Activity Index (PDAI)
Time frame: Baseline, Up to Months 36
Change from Baseline in Harvey Bradshaw Index (HBI: Simple CDAI Score)
Time frame: Baseline, Up to Months 36
Health-Related Quality of Life (HRQOL) Measured by EuroQoL Five Dimensions Five Levels (EQ-5D-5L) Scale
Time frame: Baseline, Up to Months 36
HRQOL Measured by Crohn's Anal Fistula Quality of Life (CAF-QoL) Scale
Time frame: Baseline, Up to Months 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Takeda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 36 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.