A Study of Vedolizumab in Adults With Crohn's Disease (CD)
NCT ID: NCT05192863
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2023-03-20
2025-10-31
Brief Summary
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Participants will be treated with vedolizumab according to their clinic's standard practice.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with CD
Participants diagnosed with moderately to severely active CD who are initiating vedolizumab intravenous (IV) induction treatment with the option to switch to vedolizumab subcutaneous (SC) treatment, as maintenance therapy in accordance with the current SmPC will be observed prospectively for 18 months.
No Intervention
This is a non-interventional study.
Interventions
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No Intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
2. 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
2. Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. 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.
5. Ongoing or planned pregnancy or breastfeeding participants.
6. Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.
7. Characteristics precluding IUS visualization of affected bowel segments or normal BWT of \<=3 mm for all segments.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of Calgary
Calgary, Alberta, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Ospedale ASST Rhodense
Rho, Milano, Italy
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
ASST Fatebenefratelli Sacco
Milan, , Italy
A.O.U. Federico II
Napoli, , Italy
Countries
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Related Links
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Click here for more information about this trial in easy-to-understand language.
Other Identifiers
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Vedolizumab-4038
Identifier Type: -
Identifier Source: org_study_id