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Title: Study of vedolizumab dose adjustment guided by drug level monitoring in patients with inflammatory bowel disease in remission

Verified siteRegistered drug
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Inflammatory Bowel Disease, a condition that causes inflammation in the digestive tract. The study will examine whether adjusting the dose of vedolizumab, a medication that helps control inflammation, can be done more efficiently by monitoring drug levels in the blood while maintaining the same treatment benefits.

The research involves patients who have either Crohn's Disease or Ulcerative Colitis (two types of inflammatory bowel disease) whose condition is currently stable. The medication used in this study, Entyvio, is given as an injection under the skin (subcutaneous injection). The study will compare two different approaches to giving the medication: the standard way of giving fixed doses versus adjusting the dose based on measuring drug levels in the blood.

The study will last for 48 weeks, during which participants will receive injections of the medication. The main goal is to determine if adjusting the medication dose based on blood levels can be more cost-effective than the standard dosing approach while maintaining the same treatment benefits for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    You will receive vedolizumab through subcutaneous injection (under the skin) using a pre-filled syringe containing 108 mg of medication

    The medication is called Entyvio and is used to treat inflammatory bowel disease

    This phase establishes your regular dosing schedule

  2. Step 2

    Treatment monitoring

    Your response to the medication will be monitored through therapeutic drug monitoring (TDM) - a method to measure medication levels in your body

    Regular assessments will track your condition to ensure you remain in remission (period when disease symptoms are under control)

  3. Step 3

    Medication adjustment

    Based on the monitoring results, your medication dosage may be adjusted

    The study compares standard dosing with an adjusted dosing schedule

    The adjustment aims to find the optimal medication level for your condition

  4. Step 4

    Ongoing treatment

    Treatment continues with regular subcutaneous injections according to your assigned schedule

    Regular monitoring continues throughout the study period

    The study duration extends from June 2022 to January 2026

  5. Step 5

    Final assessment

    The effectiveness of your treatment approach will be evaluated

    The study focuses on finding the most cost-effective treatment while maintaining disease control

Who can join the trial?

7 criteria

  • Patients must have inflammatory bowel disease (a chronic condition affecting the digestive tract) specifically either Crohn's disease or ulcerative colitis
  • Disease must be in remission (a period when symptoms are under control and the condition is stable)
  • Both men and women can participate
  • Participants must be adults (age 18-64 years)
  • Participants must be able to receive subcutaneous vedolizumab (medication injected under the skin)
  • Participants must not be part of any vulnerable populations (such as people unable to give informed consent)
  • Participants must be willing to follow a drug monitoring schedule to measure medication levels in their body

Who cannot join the trial?

15 criteria

  • Age under 18 years or over 65 years
  • Patients who are not in disease remission (a period when disease symptoms are under control)
  • Current active infection
  • Pregnancy or breastfeeding
  • Previous allergic reactions to vedolizumab (the study medication)
  • Severe liver disease
  • Severe kidney disease
  • Active or recent cancer in the past 5 years
  • Major surgery within the last 3 months
  • Participation in other clinical trials within the last 30 days
  • Unable to provide informed consent
  • History of non-compliance with medical treatments
  • Conditions that might interfere with study participation
  • Any contraindication to subcutaneous injections (injections under the skin)
  • Current substance abuse or severe psychiatric disorders
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Verified sites

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  • Verified

    Amsterdam UMC

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

Vedolizumab is a medication that helps treat inflammatory bowel disease (IBD). It works by blocking certain proteins in the body that cause inflammation in the digestive tract. This medication is given as an injection under the skin (subcutaneous injection). It helps maintain remission in patients who have their IBD under control by reducing inflammation in the intestines. The medication works by preventing inflammatory cells from entering the gut tissue, which helps keep the disease inactive.

What is already known about the treatment

Vedolizumab - A biologic medication administered subcutaneously (under the skin) that is used to treat inflammatory bowel disease, including conditions like Crohn's disease and ulcerative colitis. This monoclonal antibody works by blocking specific proteins that cause inflammation in the digestive tract, specifically by preventing certain white blood cells from entering the intestinal tissue. Vedolizumab belongs to the class of integrin receptor antagonists and is typically prescribed for patients who haven't responded well to other conventional treatments. The medication has shown effectiveness in maintaining remission in inflammatory bowel disease patients and is considered a targeted therapy with a favorable safety profile.

Investigated diseases

Inflammatory Bowel Disease - A chronic condition causing inflammation in the digestive tract that can affect any part from mouth to anus. The inflammation causes damage to the digestive tract lining, leading to symptoms like abdominal pain, diarrhea, fatigue, and weight loss. The disease typically follows a pattern of active periods (flares) alternating with periods of remission. It includes two main types: Crohn's disease and ulcerative colitis, which affect different parts of the digestive system. The condition often develops gradually, with symptoms becoming more noticeable over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517502-28-01Protocol codeNL80854.018.22Estimated enrolment40 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).