Health-Related Quality of Life in Crohn's Disease Participants With Complex Perianal Fistula Before and After Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn Disease
- Gastrointestinal Diseases
- Inflammatory Bowel Disease
- Intestinal Diseases
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 o...
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.
Tracking Information
- NCT #
- NCT04102163
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Takeda
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