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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04959851
Other study ID # MACS-2021-011101
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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