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)
1 other identifier
observational
99
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedStudy Start
First participant enrolled
August 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedOctober 16, 2024
October 1, 2024
2.9 years
May 13, 2021
October 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (1)
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.
Eligibility Criteria
Adult participants with moderately to severely active UC or CD receiving vedolizumab treatment in accordance with the approved SmPC.
You may qualify if:
- \. 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (7)
Medizinische Universitat Graz
Graz, 8036, Austria
Medizinische Universitat Innsbruck
Innsbruck, 6020, Austria
JKU Linz
Linz, 4021, Austria
Krankenhaus der Barmherzigen Bruder
Saint Veit/Glan, 9300, Austria
Darmpraxis Salzburg
Salzburg, 5020, Austria
Medizinische Universitat Wien
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2021
First Posted
May 18, 2021
Study Start
August 18, 2021
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
October 16, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.