CompletedNot Applicable

A Study of Vedolizumab in Adults With Crohn's Disease (CD)

Canada, Israel72 participantsStarted 2023-03-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy

Timeframe: Baseline up to 12 months

Trial details

NCT IDNCT05192863

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Crohn's Disease trials