Phase
Condition
Ulcerative Colitis
Inflammatory Bowel Disease
Bowel Dysfunction
Treatment
No Intervention
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has moderately to severely active CD with a BWT of >3 mm, based on IUS performedwithin the previous 4 weeks from baseline.
Newly initiating IV vedolizumab induction treatment in accordance with the currentSmPC either at enrolment or within 2 weeks after enrolment (switch to SC isacceptable at maintenance treatment stage).
Exclusion
Exclusion Criteria:
Prior history of intolerability, hypersensitivity to the active substance or to anyof the excipients of vedolizumab.
Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus,listeriosis, and opportunistic infections such as Progressive MultifocalLeukoencephalopathy (PML).
Cognitive incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.
Current or previous participation in an interventional clinical trial for CD withinthe past 30 days, or planned to be enrolled in an interventional clinical trial forCD.
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 normalBWT of <=3 mm for all segments.
Study Design
Study Description
Connect with a study center
University of Calgary
Calgary, Alberta T2N 4N1
CanadaSite Not Available
University of Saskatchewan
Saskatoon, Saskatchewan S7N 0W8
CanadaSite Not Available
University of McMaster
Hamilton,
CanadaSite Not Available
Hadassah Medical Center
Jerusalem, 9112001
IsraelSite Not Available
Rabin Medical Center
Petah Tikva, 4941492
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 5262000
IsraelSite Not Available
Ospedale ASST Rhodense
Rho, Milano 20017
ItalySite Not Available
Rho Hospital
Milan,
ItalySite Not Available
ASST Fatebenefratelli Sacco
Milano, 20157
ItalySite Not Available
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
A.O.U. Federico II
Napoli, 80131
ItalySite Not Available
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