Clinical trial • Not applicable • Gastroenterology
Vedolizumab for Inflammatory bowel disease | Ulcerative colitis | Crohn's disease
Not applicable trial of Vedolizumab for Inflammatory bowel disease | Ulcerative colitis | Crohn's disease.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Inflammatory bowel disease | Ulcerative colitis | Crohn's disease
- Trial Stage
- Not applicable
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 18-11-2024
- First CTIS Authorization Date
- 20-03-2025
Trial design
Randomised, open-label, control arm: vedolizumab (entyvio) 108 mg subcutaneous injections continued every 2 weeks (standard regimen). intervention arm: same product with injection interval extended to every 3 weeks at baseline and to every 4 weeks at week 24 (if clinical and biochemical remission sustained). Not applicable trial across 7 sites in Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control arm: Vedolizumab (Entyvio) 108 mg subcutaneous injections continued every 2 weeks (standard regimen). Intervention arm: same product with injection interval extended to every 3 weeks at baseline and to every 4 weeks at week 24 (if clinical and biochemical remission sustained).
- Target Sample Size
- 278
Eligibility
Recruits 278 No vulnerable populations selected; trial population is adults only. Informed consent is required from participants (see L1 SIS and ICF documents)..
- Vulnerable Population
- No vulnerable populations selected; trial population is adults only. Informed consent is required from participants (see L1 SIS and ICF documents).
Inclusion criteria
- {"criterion_text":"- Adults diagnosed with Crohn's Disease or Ulcerative Colitis in steroïd-free clinical and biochemical remission treated with bi-weekly subcutaneous vedolizumab for six or more months"}
Exclusion criteria
- {"criterion_text":"- Use of corticosteroïds, active fistula or need for IBD-related surgery"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Difference in relapse rate","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Factors associated with successful interval extension","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of patients having needed corticosteroïd treatment during follow-up","definition_or_measurement_approach":""}
- {"endpoint_text":"- Differences in emergency visits, hospitalizations and surgery","definition_or_measurement_approach":""}
- {"endpoint_text":"- Difference in quality of life","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cost-effectiveness of interval extension","definition_or_measurement_approach":""}
- {"endpoint_text":"- Differences in adverse events","definition_or_measurement_approach":""}
- {"endpoint_text":"- Vedolizumab pharmacodynamics and pharmacokinetics","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 278
- Recruitment Window Months
- 18
- Consent Approach
- Informed consent is required from adult participants; subject information and informed consent form documents (L1 SIS and ICF) are provided. No specific assent or proxy-consent procedures are indicated.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 278
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-02-2025
- Latest Decision Or Authorization Date
- 28-05-2025
- Processing Time Days
- 100
- Number Of Sites
- 7
- Number Of Participants
- 278
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Gastroenterology
- Contact Person Name
- Andrea Van der Meulen
- Contact Person Email
- b.a.hoogland@lumc.nl
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Gastroenterology
- Contact Person Name
- Marjolein Duijvestein
- Contact Person Email
- marjolein.duijvestein@radboudumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Gastroenterology
- Contact Person Name
- Fiona Van Schaik
- Contact Person Email
- f.vanschaik@umcu.nl
- Site Name
- Maastricht University Medical Center
- Department Name
- Gastroenterology
- Contact Person Name
- Zlatan Mujagic
- Contact Person Email
- loes.jansen@mumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Gastroenterology
- Contact Person Name
- Annemarie De Vries
- Contact Person Email
- a.c.devries@erasmusmc.nl
- Site Name
- Amsterdam UMC
- Department Name
- Gastroenterology
- Contact Person Name
- Mark Lowenberg
- Contact Person Email
- m.lowenberg@amsterdamumc.nl
- Site Name
- UMC Groningen
- Department Name
- Gastroenterology
- Contact Person Name
- Marijn Visschedijk
- Contact Person Email
- m.jalving@umcg.nl
Sponsor
Primary sponsor
- Full Name
- Stichting Amsterdam UMC
- 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 (solution for injection)
- Route
- Subcutaneous
- Authorisation Status
- Authorised (marketing authorisation EU/1/14/923/002)
- Starting Dose
- 108 mg
- Frequency
- Control: every 2 weeks (bi-weekly); Intervention: extended to every 3 weeks at baseline and to every 4 weeks at week 24 if remission sustained
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