NCT04102163

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

September 23, 2019

Last Update Submit

July 20, 2021

Conditions

Crohn DiseaseInflammatory Bowel DiseaseGastrointestinal DiseasesIntestinal Diseases

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 12 After Treatment Initiation for CPF

    QoLAF-Q evaluates quality of life (QoL) among participants with both simple and complex anal fistula (AF). It is composed of a total of 14 items with a Likert scale from 1 to 5 points. Its score range is the following: zero impact=14 points; limited impact=15 to 28 points; moderate impact=29 to 42 points; high impact=43 to 56 points; and very high impact=57 to 70 points.

    Baseline and Month 12

Secondary Outcomes (22)

  • Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 6 After Treatment Initiation for CPF

    Baseline and Month 6

  • Percentage of Participants With Clinically Significant Change From Baseline in QoLAF-Q Score at Months 6 and 12 After Treatment for CPF

    Baseline, Months 6 and 12

  • Change From Baseline in EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) Scores at Months 6 and 12 After Treatment for CPF

    Baseline, Months 6 and 12

  • Change From Baseline in Faecal Incontinence Quality of Life Scale (FIQOL) Scores at Months 6 and 12 After Treatment for CPF

    Baseline, Months 6 and 12

  • Change From Baseline in Perceived Stress Scale (PSS) Scores at Months 6 and 12 After Treatment for CPF

    Baseline, Months 6 and 12

  • +17 more secondary outcomes

Study Arms (1)

All Participants

Participants diagnosed with CD and CPF from approximately 20 Spanish hospitals, who will initiate medical or surgical treatment for their CPF within the eligibility period from Sep 2020 to Sep 2021, will be observed prospectively for approximately 31 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants diagnosed with CD and CPF, who will initiate medical or surgical treatment for their CPF within Sep 2020 to Sep 2021, will be observed prospectively.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hospital Reina Sofia

Córdoba, Andalusia, 14004, Spain

Location

Hospital San Cecilio

Granada, Andalusia, 18016, Spain

Location

Hospital Universiario Juan Ramon Jimenez

Huelva, Andalusia, 21005, Spain

Location

Hospital Regional de Malaga

Málaga, Andalusia, 29010, Spain

Location

Hospital Virgen del Rocio

Seville, Andalusia, 41013, Spain

Location

Hospital Nuestra Senora de la Candelaria

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, Castille and León, 47012, Spain

Location

Hospital Santa creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Parc Tauli

Barcelona, Catalonia, 08208, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Complejo Hospitalario Universitario de Ferrol

A Coruña, Galicia, 15405, Spain

Location

Complejo Hospitalario de Pontevedra

Pontevedra, Galicia, 36071, Spain

Location

Hospital de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Gregorio Maranon

Madrid, Madrid, 28007, Spain

Location

Fundacion Jimenez Diaz

Madrid, Madrid, 28040, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel DiseasesGastrointestinal DiseasesIntestinal Diseases

Condition Hierarchy (Ancestors)

GastroenteritisDigestive System Diseases

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

January 26, 2021

Primary Completion

May 26, 2021

Study Completion

May 26, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

ES(20)