A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease (VARIETY-Belgium)

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04959851
• Other study ID #: MACS-2021-011101
• Status: Active, not recruiting
• Start date: December 2, 2021
• Est. completion date: June 30, 2024

Study information

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

Clinical Trial Summary

IBD consists of either ulcerative colitis or Crohn's disease.

The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include how vedolizumab is given, which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).

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 according to the current SmPC in the real world setting.

The study will enroll approximately 200 participants. The data will be collected prospectively 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 Belgium at specialized gastroenterology centers.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• 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, Ulcerative
• Crohn Disease
• Crohns Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Belgium	GZA St. Vincentius	Antwerpen
Belgium	UZA	Antwerpen
Belgium	Erasme	Bruxelles
Belgium	ZOL	Genk
Belgium	AZ St. Lucas	Gent
Belgium	CHC MontLégia	Liège
Belgium	CHR Citadelle	Liège
Belgium	CHU Liège	Liège
Belgium	AZ Delta	Roeselaere
Belgium	CHWAPI	Tournai

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Persisting to 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 the 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