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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Reina Sofia
Córdoba, Andalusia, Spain
Hospital San Cecilio
Granada, Andalusia, Spain
Hospital Universiario Juan Ramon Jimenez
Huelva, Andalusia, Spain
Hospital Regional de Malaga
Málaga, Andalusia, Spain
Hospital Virgen del Rocio
Seville, Andalusia, Spain
Hospital Nuestra Senora de la Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital Universitario Rio Hortega
Valladolid, Castille and León, Spain
Hospital Santa creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain
Start Date
January 26, 2021
Primary Completion Date
May 26, 2021
Completion Date
May 26, 2021
Last Updated
July 27, 2021
19
ACTUAL participants
Lead Sponsor
Takeda
NCT06290258
NCT06226883
Data Source & Attribution
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