A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real-World Practice

Study Overview
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Brief Summary
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Vedolizumab is a medicine that helps to reduce symptoms of IBD and the associated inflammation in the digestive system for participants with ulcerative colitis or Crohn's disease. In this study, participants with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

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 in the real world setting. The study will enroll approximately 100 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 Austria at specialized gastroenterology centers. The overall duration of the study will be 24 months. Data will be collected at baseline, at 3 months after induction, and every 6 months after induction, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.

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 (VARIETY-AUT)

Conditions
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Inflammatory Bowel Diseases, Crohns Disease, Colitis, Ulcerative

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 currently ongoing vedolizumab intravenous (IV) treatment in line with current Summary of Product Characteristics (SmPC) or local prescribing information 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 on 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 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