Status:
COMPLETED
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland
Lead Sponsor:
Takeda
Conditions:
Inflammatory Bowel Disease (IBD)
Crohn's Disease
Eligibility:
All Genders
18+ years
Brief Summary
The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved...
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
- Participants with moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC and National Drug Program (NDP) 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 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 13 2025
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT05384080
Start Date
August 8 2022
End Date
June 13 2025
Last Update
September 2 2025
Active Locations (11)
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1
Uniwersytecki Szpital Kliniczny
Wroclaw, Dolnoslskie, Poland, 50-556
2
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie
Międzychód, Greater Poland Voivodeship, Poland, 64-400
3
Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
Poznan, Greater Poland Voivodeship, Poland, 60-335
4
Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168