Status:
COMPLETED
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real-World Practice
Lead Sponsor:
Takeda
Conditions:
Inflammatory Bowel Diseases
Crohns Disease
Eligibility:
All Genders
18+ years
Brief Summary
Vedolizumab is a medicine that helps to reduce symptoms of IBD and the associated inflammation in the digestive system for participants with ulcerative colitis or Crohn's disease. In this study, part...
Detailed Description
This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedoli...
Eligibility Criteria
Inclusion
- 1\. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.
Exclusion
- Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
- Current or planned participation in an interventional clinical trial for CD or UC.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Key Trial Info
Start Date :
August 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04890262
Start Date
August 18 2021
End Date
June 30 2024
Last Update
October 16 2024
Active Locations (7)
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1
Medizinische Universitat Graz
Graz, Austria, 8036
2
Medizinische Universitat Innsbruck
Innsbruck, Austria, 6020
3
JKU Linz
Linz, Austria, 4021
4
Krankenhaus der Barmherzigen Bruder
Saint Veit/Glan, Austria, 9300