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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ayymqtxmi Uio	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.06.2022

Trial locations

Investigated drugs:

Vedolizumab

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.

Investigated diseases:

Inflammatory bowel disease

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 ID:

2024-517502-28-01

Protocol code:

NL80854.018.22

NCT ID:

NCT20220008

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?