Clinical trial NCT04102163: Health-Related Quality of Life in Crohn's Disease Participants With Complex Perianal Fistula Before and After Treatment
Official title: A Multicentre Prospective Observational Study to Assess Health Related Quality of Life in Crohn's Disease Patients With Complex Perianal Fistula Before and After Treatment: the CALYPSO Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn Disease
Inflammatory Bowel Disease
Gastrointestinal Diseases
Intestinal Diseases
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 12 After Treatment Initiation for CPF
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 6 After Treatment Initiation for CPF
timeFrame: Baseline and Month 6
measure: Percentage of Participants With Clinically Significant Change From Baseline in QoLAF-Q Score at Months 6 and 12 After Treatment for CPF
timeFrame: Baseline, Months 6 and 12
measure: Change From Baseline in EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) Scores at Months 6 and 12 After Treatment for CPF
timeFrame: Baseline, Months 6 and 12
measure: Change From Baseline in Faecal Incontinence Quality of Life Scale (FIQOL) Scores at Months 6 and 12 After Treatment for CPF
timeFrame: Baseline, Months 6 and 12
measure: Change From Baseline in Perceived Stress Scale (PSS) Scores at Months 6 and 12 After Treatment for CPF
timeFrame: Baseline, Months 6 and 12
measure: Change From Baseline in International Index of Erectile Function (IIEF) Scores at Months 6 and 12 After Treatment for CPF
timeFrame: Baseline, Months 6 and 12
measure: Change From Baseline in Female Sexual Function Index (FSFI) Scores at Months 6 and 12 After Treatment for CPF
timeFrame: Baseline, Months 6 and 12
measure: Number of Participants Based on Type of Treatment, Dose, Dose Frequency and Date of Initiation
timeFrame: Baseline
measure: Number of Participants Based on Biological Data
timeFrame: Baseline, Months 6 and 12
measure: Number of Participants With Comorbidities Based on Charlson Comorbidity Index
timeFrame: Baseline
measure: Number of Participants With Comedications for Treatment of CD and Fistula
timeFrame: Baseline
measure: Number of Participants With Target CPF
timeFrame: Baseline
measure: Number of Participants With the Presence of new CPF at Months 6 and 12
timeFrame: Months 6 and 12
measure: Montreal Classification Assessed at Baseline
timeFrame: Baseline
measure: Number of Participants With Clinical characteristics Based on Harvey Bradshaw Index (HBI)
timeFrame: Baseline, Months 6 and 12
measure: Number of Participants With Clinical Characteristics Based on Perianal Crohn´s Disease Activity Index (PDAI) or Fistula Drainage Assessment (FDA)
timeFrame: Baseline, Months 6 and 12
measure: Number of Occurrences of Treatment Switching or Dose Change
timeFrame: Months 6 and 12
measure: Relation Between Participants QoLAF-Q Score and Clinical Variables
timeFrame: Baseline
measure: Number of Participants Based on Methods Used to Evaluate the Response to Different Treatments for CPF in Routine Clinical Practice
timeFrame: Months 6 and 12
measure: Number of Participants Based on Effectiveness of Different Treatment Options for CPF Grouped According to Therapeutic Class
timeFrame: Months 6 and 12
measure: Health Care Resources Utilization (HCRU)
timeFrame: Baseline, Months 6 and 12
measure: Correlation Between the Change in CD Participant's Scores in the QoLAF-Q, the EQ-5D-5L and Rapid Assessment Faecal Incontinence Score (RAFIS)
timeFrame: Baseline, Months 6 and 12
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
state: Andalucia
city: Granada
country: Spain
facility: Hospital San Cecilio
state: Andalucia
city: Huelva
country: Spain
facility: Hospital Universiario Juan Ramon Jimenez
state: Andalucia
city: Malaga
country: Spain
facility: Hospital Regional de Malaga
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
state: Andalucia
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Nuestra Senora de la Candelaria
state: Canarias
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castilla Y Leon
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Hospital Santa creu i Sant Pau
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital Parc Tauli
state: Cataluna
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Cataluna
city: Madrid
country: Spain
facility: Hospital La Princesa
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital La Paz
state: Comunidad De Madrid
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
state: Galicia
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
state: Galicia
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
state: Madrid
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: