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

Takeda

Status: Terminated

Conditions: Gastrointestinal Diseases; Intestinal Diseases; Inflammatory Bowel Disease; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04102163

IBD-5008

U1111-1232-1975 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, or suprasphincteric], multiple external openings, perianal abscess, anal stenosis, or proctitis).
2. Has tried and failed at least one prior treatment for CPF.
3. Starting a new pharmacological or surgical treatment for CPF.

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 eligibility period.
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.

Trial design

19 participants in 1 patient group

All Participants

Description:

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.