Clinical trial • Phase IV • Gastroenterology

VEDOLIZUMAB for Inflammatory bowel disease | Crohn's disease | Ulcerative colitis

Phase IV trial of VEDOLIZUMAB for Inflammatory bowel disease | Crohn's disease | Ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Inflammatory bowel disease | Crohn's disease | Ulcerative colitis
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
05-12-2024
First CTIS Authorization Date
14-01-2025

Trial design

Randomised, normal dosing regimen (standard dosing) of vedolizumab (comparator described as 'normal dosing regimen' in protocol/objective).-controlled Phase IV trial across 1 site in Netherlands.

Randomised
Yes
Comparator
Normal dosing regimen (standard dosing) of vedolizumab (comparator described as 'normal dosing regimen' in protocol/objective).
Biomarker Stratified
True, therapeutic drug monitoring (vedolizumab drug levels)
Target Sample Size
40

Eligibility

Recruits 40 Vulnerable population not selected; informed consent handled via adult subject information sheet and informed consent form (L1 SIS and ICF adults). No assent process or paediatric consent described..

Vulnerable Population
Vulnerable population not selected; informed consent handled via adult subject information sheet and informed consent form (L1 SIS and ICF adults). No assent process or paediatric consent described.

Inclusion criteria

  • {"criterion_text":"- crohn's disease or ulcerative colitis in remission"}

Exclusion criteria

  • {"criterion_text":"- presence of anti-drug antibodies against vedolizumab"}
  • {"criterion_text":"- Patients with short bowel syndrome, an ostomy or a symptomatic stricture"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- cost-effectiveness of therapeutic drug monitoring based drug de-escalation","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
40
Recruitment Window Months
43
Consent Approach
Informed consent obtained from adult participants; subject information sheet and informed consent form for adults available (document: L1 SIS and ICF adults). No paediatric assent or translations specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Netherlands

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
14-01-2025
Processing Time Days
1
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Geert D'Haens
Principal Investigator Email
ctis@amsterdamumc.nl
Contact Person Name
Geert D'Haens
Contact Person Email
ctis@amsterdamumc.nl
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Amsterdam UMC Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Entyvio 108 mg solution for injection in pre-filled syringe
Active Substance
VEDOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Marketing authorisation listed (EU/1/14/923/003)
Maximum Dose
maxDailyDoseAmount 7.7 mg; maxTotalDoseAmount 2592 mg

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