A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease (VARIETY-Belgium)

Study Overview
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Brief Summary
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IBD consists of either ulcerative colitis or Crohn's disease. 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 how vedolizumab is given, which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).

Detailed Description
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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 vedolizumab according to the current SmPC in the real world setting. The study will enroll approximately 200 participants. The data will be collected prospectively 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 Belgium at specialized gastroenterology centers.

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

Conditions
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Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohns Disease

Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With Inflammatory Bowel Disease (IBD)<br>Participants diagnosed with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing vedolizumab intravenous induction treatment or maintenance intravenous treatment in accordance with the current Summary of Product Characteristics (SmPC) along with the option to switch to vedolizumab subcutaneous (SC) treatment, will be observed prospectively for 24 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to Participants With Treatment Change Up to 12 Months |  | Baseline up to 12 months | 
| Time to any Treatment Change |  | Baseline up to 24 months | 
| Number of Participants With Reason for Treatment Change |  | Baseline up to 24 months | 
| Number of Participants With Change in Vedolizumab Dosing Frequency |  | Baseline up to 24 months | 
| Number of Participants Who Discontinued the Vedolizumab Treatment |  | Baseline up to 24 months | 
| Number of Participants Who Changed to Another Treatment |  | Baseline up to 24 months | 

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