A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)

Completed

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 severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include the administration choices which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).

Treatment will be determined by the study doctor according to routine clinical practice.

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 enroll approximately 120 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 Croatia and Slovenia having specialized gastroenterology centers. The overall duration of the study will be at least 26 months. Data will be collected at baseline, at 3 months (+/- 1 month) after induction, and every 6 months (+/- 1 month) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Discontinued the Vedolizumab Treatment	Baseline up to 12 months
Number of Participants Who Changed to Another Treatment	Baseline up to 12 months
Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to Participants With Treatment Change at 12 Months	Baseline up to 12 months
Time to any Treatment Change	Baseline up to 12 months
Number of Participants With Reason for Treatment Change	Baseline up to 12 months
Number of Participants With Change in Vedolizumab Dosing Frequency	Baseline up to 12 months

Secondary Outcome Measures

Name	Time	Method

Locations (8): Klinicki bolnicki centar Osijek (University medical centre Osijek)
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Osijek, Croatia
Klinicki bolnicki centar Rijeka (University medical centre Rijeka)
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Rijeka, Croatia
Univerzitetni klinicni center Ljubljana (University medical Centre Ljubljana)
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Ljubljana, Slovenia
Univerzitetni klinicni center Maribor (University medical centre Maribor)
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Maribor, Slovenia
Klinicki bolnicki centar Zagreb (University medical centre Zagreb)
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Zagreb, Croatia
Splosna bolnisnica Celje (General hospital Celje)
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Celje, Slovenia
Klinicki bolnicki centar Split (University medical centre Split)
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Split, Croatia
Klinicki bolnicki centar Sestre milosrdnice (University medical centre Sestre milosrdnice)
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Zagreb, Croatia