Status:
COMPLETED
A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)
Lead Sponsor:
Takeda
Conditions:
Inflammatory Bowel Diseases
Crohns Disease
Eligibility:
All Genders
18+ years
Brief Summary
Inflammatory bowel disease consists of either ulcerative colitis (UC) or Crohn's disease (CD). The main aim of this study is to describe real-world treatment patterns in adults with moderate to sever...
Detailed Description
This is a non-interventional, prospective study of participants with IBD who initiated or who are currently ongoing induction or maintenance with vedolizumab in the real world setting. The study will...
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 :
February 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 12 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04885920
Start Date
February 22 2022
End Date
March 12 2024
Last Update
April 16 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinicki bolnicki centar Osijek (University medical centre Osijek)
Osijek, Croatia, 31000
2
Klinicki bolnicki centar Rijeka (University medical centre Rijeka)
Rijeka, Croatia, 51000
3
Klinicki bolnicki centar Split (University medical centre Split)
Split, Croatia, 21000
4
Klinicki bolnicki centar Sestre milosrdnice (University medical centre Sestre milosrdnice)
Zagreb, Croatia, 10000