A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colitis Ulcerative
- Crohn's Disease
- Inflammatory Bowel 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 non-interventional, prospective study of participants with IBD who initiated or who are currently ongoing induction or maintenance with vedolizumab in the real world setting. The study will enroll approximately 120 participants. The data will be collected prospectively at the study sites a...
This is a non-interventional, prospective study of participants with IBD who initiated or who are currently ongoing induction or maintenance with vedolizumab in the real world setting. The study will enroll approximately 120 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort: Participants with IBD This multi-center study will be conducted in Croatia and Slovenia having specialized gastroenterology centers. The overall duration of the study will be at least 26 months. Data will be collected at baseline, at 3 months (+/- 1 month) after induction, and every 6 months (+/- 1 month) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.
Tracking Information
- NCT #
- NCT04885920
- Collaborators
- Not Provided
- Investigators
- Study Director: Study Director Takeda
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