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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 December 2024 |
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Main ID: |
NCT05113095 |
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Date of registration:
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05/11/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Survey of Darvadstrocel in People with Crohn's Disease
J-INSPIRE |
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Scientific title:
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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) |
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Date of first enrolment:
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November 30, 2021 |
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Target sample size:
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275 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05113095 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Name:
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Takeda Contact |
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Address:
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Telephone:
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+1-877-825-3327 |
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Email:
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medinfoUS@takeda.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who
received Darvadstrocel will be included.
Exclusion Criteria None
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Biological: Darvadstrocel
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Primary Outcome(s)
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Number of Participants with Adverse Events
[Time Frame: 36 Months]
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Percentage of Participants who Achieve Clinical Response
[Time Frame: Baseline, Up to Months 36]
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Percentage of Participants who Achieve Combined Remission
[Time Frame: Baseline, Up to Months 36]
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Percentage of Participants who Achieve Clinical Remission
[Time Frame: Baseline, Up to Months 36]
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Secondary Outcome(s)
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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]
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HRQOL Measured by Crohn's Anal Fistula Quality of Life (CAF-QoL) Scale
[Time Frame: Baseline, Up to Months 36]
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Change from Baseline in Harvey Bradshaw Index (HBI: Simple CDAI Score)
[Time Frame: Baseline, Up to Months 36]
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Change from Baseline in Perianal Disease Activity Index (PDAI)
[Time Frame: Baseline, Up to Months 36]
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Health-Related Quality of Life (HRQOL) Measured by EuroQoL Five Dimensions Five Levels (EQ-5D-5L) Scale
[Time Frame: Baseline, Up to Months 36]
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Percentage of Participants with New Perianal Abscess in a Previously Treated Anal Fistula
[Time Frame: Baseline, Up to Months 36]
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Secondary ID(s)
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Alofisel-5008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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