Health-Related Quality of Life in Crohn's Disease Participants With Complex Perianal Fistula Before and After Treatment

Last updated: July 20, 2021
Sponsor: Takeda
Overall Status: Terminated

Phase

N/A

Condition

Ulcers

Crohn's Disease (Pediatric)

Colic

Treatment

N/A

Clinical Study ID

NCT04102163
IBD-5008
U1111-1232-1975
  • Ages > 18
  • All Genders

Study 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 Fistula (CPF), by the Quality of Life in patients with Anal Fistula Questionnaire (QoLAF-Q), at 12 months after treatment initiation in routine clinical practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with CD and CPF (defined as a fistula meeting any of the following criteria:high location [high intersphincteric, high transsphincteric, extrasphincteric, orsuprasphincteric], multiple external openings, perianal abscess, anal stenosis, orproctitis).
  2. Has tried and failed at least one prior treatment for CPF.
  3. Starting a new pharmacological or surgical treatment for CPF.

Exclusion

Exclusion Criteria:

  1. Diagnosed with indeterminate/unspecified type of inflammatory bowel disease (IBD).
  2. Diagnosed with ulcerative colitis.
  3. Diagnosed with fistula other than CPF (example rectovaginal).
  4. Treated with darvadstrocel or other stem cells-based therapies within the eligibilityperiod.
  5. Previous fecal incontinence.
  6. Lost to site follow-up for reasons other than death.
  7. Participates or plans to participate in any interventional clinical trial.
  8. Non fluent in Spanish.

Study Design

Total Participants: 19
Study Start date:
January 26, 2021
Estimated Completion Date:
May 26, 2021

Study 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 HRQoL.

The study will enroll approximately 300 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Spain. The study will collect data from a routine medical practice visits for CD participants with CPF and an application that will be designed ad hoc and will passively record participant's data. The overall duration of this study will be approximately 31 months. Participants will be followed up at Months 6 and 12 post-treatment.

Connect with a study center

  • Hospital Reina Sofia

    Cordoba, Andalucia 14004
    Spain

    Site Not Available

  • Hospital San Cecilio

    Granada, Andalucia 18016
    Spain

    Site Not Available

  • Hospital Universiario Juan Ramon Jimenez

    Huelva, Andalucia 21005
    Spain

    Site Not Available

  • Hospital Regional de Malaga

    Malaga, Andalucia 29010
    Spain

    Site Not Available

  • Hospital Virgen del Rocio

    Sevilla, Andalucia 41013
    Spain

    Site Not Available

  • Hospital Nuestra Senora de la Candelaria

    Santa Cruz de Tenerife, Canarias 38010
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, Castilla Y Leon 37007
    Spain

    Site Not Available

  • Hospital Universitario Rio Hortega

    Valladolid, Castilla Y Leon 47012
    Spain

    Site Not Available

  • Hospital Parc Tauli

    Barcelona, Cataluna 08208
    Spain

    Site Not Available

  • Hospital Santa creu i Sant Pau

    Barcelona, Cataluna 08025
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, Cataluna 08035
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    Hospitalet de Llobregat, Cataluna 08907
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz

    Madrid, Comunidad De Madrid 28040
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, Comunidad De Madrid 28040
    Spain

    Site Not Available

  • Hospital Gregorio Maranon

    Madrid, Comunidad De Madrid 28007
    Spain

    Site Not Available

  • Hospital La Paz

    Madrid, Comunidad De Madrid 28046
    Spain

    Site Not Available

  • Hospital La Princesa

    Madrid, Comunidad De Madrid 28006
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Ferrol

    A Coruna, Galicia 15405
    Spain

    Site Not Available

  • Complejo Hospitalario de Pontevedra

    Pontevedra, Galicia 36071
    Spain

    Site Not Available

  • Hospital de Fuenlabrada

    Fuenlabrada, Madrid 28942
    Spain

    Site Not Available

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