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

Completed

• Conditions: Crohns Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

• Registration Number: NCT04890262
• Lead Sponsor: Takeda

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-18
• Study Start: 2021-08-18
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Read More

Exclusion Criteria

1. 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.
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Change in Vedolizumab Dosing Frequency	Baseline up to 24 months
Number of Participants With Reason for Treatment Change	Baseline up to 24 months
Number of Participants Who Discontinued Vedolizumab Treatment	Baseline up to 24 months
Time to any Treatment Change	Baseline up to 24 months
Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 12 Months	Baseline up to 12 months
Number of Participants Who Changed to Another Treatment	Baseline up to 24 months

Trial Locations

Locations (7)

Medizinische Universitat Graz; 🇦🇹 Graz, Austria

Medizinische Universitat Innsbruck; 🇦🇹 Innsbruck, Austria

Krankenhaus der Barmherzigen Bruder; 🇦🇹 St. Veit/Glan, Austria

JKU Linz; 🇦🇹 Linz, Austria

Darmpraxis Salzburg; 🇦🇹 Salzburg, Austria

Medizinische Universitat Wien; 🇦🇹 Wien, Austria

Klinikum Wels-Grieskirchen GmbH; 🇦🇹 Wels, Austria