Status:
TERMINATED
Health-Related Quality of Life in Crohn's Disease Participants With Complex Perianal Fistula Before and After Treatment
Lead Sponsor:
Takeda
Conditions:
Crohn Disease
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess the impact of treatment (medical and/or surgical) on Health-related Quality of Life (HRQoL) in participants with Crohn's Disease (CD) and Complex Perianal Fistul...
Detailed Description
This is a prospective follow-up post-authorization observational study of participants with CD and CPF. The study will provide real-world data on how CPF treatments in CD participants affect their HRQ...
Eligibility Criteria
Inclusion
- Diagnosed with CD and CPF (defined as a fistula meeting any of the following criteria: high location \[high intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric\], multiple external openings, perianal abscess, anal stenosis, or proctitis).
- Has tried and failed at least one prior treatment for CPF.
- Starting a new pharmacological or surgical treatment for CPF.
Exclusion
- Diagnosed with indeterminate/unspecified type of inflammatory bowel disease (IBD).
- Diagnosed with ulcerative colitis.
- Diagnosed with fistula other than CPF (example rectovaginal).
- Treated with darvadstrocel or other stem cells-based therapies within the eligibility period.
- Previous fecal incontinence.
- Lost to site follow-up for reasons other than death.
- Participates or plans to participate in any interventional clinical trial.
- Non fluent in Spanish.
Key Trial Info
Start Date :
January 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04102163
Start Date
January 26 2021
End Date
May 26 2021
Last Update
July 27 2021
Active Locations (20)
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1
Hospital Reina Sofia
Córdoba, Andalusia, Spain, 14004
2
Hospital San Cecilio
Granada, Andalusia, Spain, 18016
3
Hospital Universiario Juan Ramon Jimenez
Huelva, Andalusia, Spain, 21005
4
Hospital Regional de Malaga
Málaga, Andalusia, Spain, 29010