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Clinical Trial Summary

The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. Participants will be treated with vedolizumab according to their clinic's standard practice.


Clinical Trial Description

This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating or currently ongoing induction treatment with vedolizumab according to the current summary of product characteristics (SmPC) in the real world setting. The study will enroll approximately 100 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 CD This multi-center study will be conducted in Canada, Italy, and Israel at specialized gastroenterology centers. The overall duration of the study will be 18 months. Data will be collected at baseline, at 10 weeks (± 4 weeks) after induction, and every 6 months (± 4 weeks) after that, and at the time of changes in treatment, study discontinuation and/or at routine follow-up visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05192863
Study type Observational
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email [email protected]
Status Not yet recruiting
Phase
Start date March 31, 2022
Completion date April 30, 2024

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