A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
NCT ID: NCT04989907
Last Updated: 2025-12-29
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
92 participants
OBSERVATIONAL
2021-09-08
2024-05-17
Brief Summary
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In this study, adults with UC or CD will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab.
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
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 IBD
This multi-center study will be conducted in Switzerland at specialized gastroenterology centers. The overall duration of the study will be 24 months (104 weeks). Data will be collected at baseline, at 3 months (12 weeks) after induction, and every 6 months (24 weeks) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months (48 weeks).
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 Inflammatory Bowel Disease (IBD)
Participants diagnosed with moderately to severely active IBD (UC or CD) who are currently ongoing vedolizumab intravenous (IV) induction treatment in line with local prescribing information with the option to switch to vedolizumab subcutaneous (SC) treatment, will be observed prospectively for 12 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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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Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Clarunis AG
Basel, , Switzerland
Bauchzentrum INSELSPITAL, Universitatsspital Bern
Bern, , Switzerland
Gastroenterologische Praxis Balsiger, Seibold & Partner Crohn-Colitis-Zentrum
Bern, , Switzerland
Zentrum fur Gastroenterologie und Hepatologie AG
Zurich, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
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-4034
Identifier Type: -
Identifier Source: org_study_id