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

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)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • Linz, Austria, 4021
    • JKU Linz
  • Salzburg, Austria, 5020
    • Darmpraxis Salzburg
  • St. Veit/Glan, Austria, 9300
    • Krankenhaus der Barmherzigen Brüder
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen GmbH
  • Wien, Austria, 1090
    • Medizinische Universitat Wien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderately to severely active UC or CD receiving vedolizumab treatment in accordance with the approved SmPC.

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Participants With Inflammatory Bowel Disease (IBD); 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?

Primary Outcome Measures

Outcome Measure	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 Changed to Another Treatment	Baseline up to 24 months
Number of Participants Who Discontinued Vedolizumab Treatment	Baseline up to 24 months

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Vedolizumab-4035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No