A Survey of Darvadstrocel in People With Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Darvadstrocel.
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Biological Darvadstrocel
Darvadstrocel injection
Primary outcome measures
- Number of Participants with Adverse Events [Time frame: 36 Months]
- Percentage of Participants who Achieve Clinical Response [Time frame: Baseline, Up to Months 36]
- Percentage of Participants who Achieve Clinical Remission [Time frame: Baseline, Up to Months 36]
- Percentage of Participants who Achieve Combined Remission [Time frame: Baseline, Up to Months 36]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.
Exclusion Criteria None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Takeda selected site — Tokyo
Identifiers
NCT: NCT05113095 · Alofisel-5008 · jRCT2033210424