Status:
COMPLETED
A Study of Vedolizumab in Adults With Crohn's Disease (CD)
Lead Sponsor:
Takeda
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Brief 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 vedoliz...
Detailed Description
This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating treatment with vedolizumab according to the current summary of product characte...
Eligibility Criteria
Inclusion
- Has moderately to severely active CD with a BWT of \>3 mm, based on IUS performed within the previous 4 weeks from baseline.
- Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).
Exclusion
- Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.
- Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.
- Ongoing or planned pregnancy or breastfeeding participants.
- Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.
- Characteristics precluding IUS visualization of affected bowel segments or normal BWT of \<=3 mm for all segments.
Key Trial Info
Start Date :
March 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05192863
Start Date
March 20 2023
End Date
October 31 2025
Last Update
November 13 2025
Active Locations (10)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
2
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
3
Hadassah Medical Center
Jerusalem, Israel, 9112001
4
Rabin Medical Center
Petah Tikva, Israel, 4941492