Clinical trial NCT04959851: A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease (VARIETY-Belgium)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohns Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-07-13
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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).

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to Participants With Treatment Change Up to 12 Months
timeFrame: Baseline up to 12 months
measure: Time to any Treatment Change
timeFrame: Baseline up to 24 months
measure: Number of Participants With Reason for Treatment Change
timeFrame: Baseline up to 24 months
measure: Number of Participants With Change in Vedolizumab Dosing Frequency
timeFrame: Baseline up to 24 months
measure: Number of Participants Who Discontinued the Vedolizumab Treatment
timeFrame: Baseline up to 24 months
measure: Number of Participants Who Changed to Another Treatment
timeFrame: Baseline up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: GZA St. Vincentius
city: Antwerpen
country: Belgium
facility: UZA
city: Bruxelles
country: Belgium
facility: Erasme
city: Genk
country: Belgium
facility: ZOL
city: Gent
country: Belgium
facility: AZ St. Lucas
city: Liège
country: Belgium
facility: CHR Citadelle
city: Liège
country: Belgium
facility: CHU Liège
city: Liège
country: Belgium
facility: CHC MontLégia
city: Roeselaere
country: Belgium
facility: AZ Delta
city: Tournai
country: Belgium
facility: CHWAPI
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: