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

Inflammatory Bowel Diseases Clinical Trial

— VARIETY-AUT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04890262
• Other study ID #: Vedolizumab-4035
• Status: Completed
• Start date: August 18, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohns Disease
• Inflammatory Bowel Diseases
• Ulcer

Locations

Country	Name	City	State
Austria	Medizinische Universitat Graz	Graz
Austria	Medizinische Universitat Innsbruck	Innsbruck
Austria	JKU Linz	Linz
Austria	Darmpraxis Salzburg	Salzburg
Austria	Krankenhaus der Barmherzigen Bruder	St. Veit/Glan
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Austria	Medizinische Universitat Wien	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 12 Months		Baseline up to 12 months
Primary	Time to any Treatment Change		Baseline up to 24 months
Primary	Number of Participants With Reason for Treatment Change		Baseline up to 24 months
Primary	Number of Participants With Change in Vedolizumab Dosing Frequency		Baseline up to 24 months
Primary	Number of Participants Who Discontinued Vedolizumab Treatment		Baseline up to 24 months
Primary	Number of Participants Who Changed to Another Treatment		Baseline up to 24 months

External Links

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