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

Study Overview
=================
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.

Official Title
-----------------
Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes

Conditions
-----------------
Inflammatory Bowel Diseases, Crohns Disease, Colitis, Ulcerative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With IBD<br>Participants diagnosed with moderately to severely active IBD (UC or CD) who initiated or are currently ongoing vedolizumab IV induction treatment in accordance with the current Summary of Product Characteristics (SmPC) or receiving vedolizumab ongoing or maintenance IV treatment with the option to switch to vedolizumab SC treatment, will be observed prospectively for at least 12 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Therapy