RecruitingRare disease

Exploring Precision Dosing of Infliximab for Patients with Steroid-Resistant Severe Ulcerative Colitis

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What is this trial about?

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

This clinical trial is focused on exploring a treatment for acute severe ulcerative colitis, a condition where the colon becomes inflamed, leading to severe symptoms like frequent diarrhea and abdominal pain. The study will use a medication called Infliximab, which is given through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. Infliximab is a type of protein that helps reduce inflammation in the body.

The purpose of this study is to investigate how well a method called model-informed precision dosing works when using Infliximab as a rescue therapy for patients who have not responded to steroid treatments. This method aims to tailor the dosage of Infliximab to each patient's needs, potentially improving treatment outcomes. Participants in the study will receive Infliximab and will be monitored over a period of time to assess how their bodies respond to the treatment.

The study will track various outcomes, such as the ability to avoid surgery to remove the colon, known as colectomy, and the achievement of clinical remission, which means the symptoms of ulcerative colitis are reduced or disappear. The study will also look at the overall health and recovery of participants, including their response to the treatment without the need for additional steroids. The trial aims to provide valuable insights into the effectiveness and practicality of using precision dosing with Infliximab for treating acute severe ulcerative colitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial consent and screening
Sign a written informed consent form and any required privacy authorization within 48 hours after the initiation of any study procedures.
Receive a first dose of infliximab or have already received a first dose of 10 mg/kg infliximab within 48 hours before screening as rescue therapy for acute severe ulcerative colitis (ASUC).
Step 2
Hospital admission and initial treatment
Be admitted to the hospital with a diagnosis of ASUC, confirmed by pathology and defined according to the Truelove and Witts’ criteria.
Receive infliximab as rescue therapy for this episode of ASUC, administered through an intravenous infusion.
Step 3
Monitoring and dosage adjustment
Undergo regular monitoring to assess the response to infliximab therapy.
Adjust the dosage of infliximab based on model-informed precision dosing (MIPD) to achieve the desired concentration targets.
Step 4
Short-term evaluation
Evaluate colectomy-free survival, clinical response, and remission at 12 weeks after the start of infliximab therapy.
Assess biological and endoscopic responses, as well as histological disease activity, during the first 12 weeks.
Step 5
Long-term follow-up
Continue monitoring for colectomy-free survival at 24 weeks, which marks the end of the safety follow-up period.
Evaluate the need for additional rescue therapy and monitor for any postoperative complications.
Step 6
Final assessment
Assess the total infliximab dose, number of infusions, and direct cost of therapy during the first 12 weeks.
Determine the ratio of direct cost to the proportion of patients achieving colectomy-free survival at week 12.

Who can join the trial?

10 criteria

The patient or their legal representative must sign a written consent form and any necessary privacy authorization before or within 48 hours after starting any study procedures.
The patient will receive a first dose of a medication called **infliximab**, or has already received a first dose of 10 mg/kg infliximab within 48 hours before screening and signing the consent form, as a rescue treatment for this episode of **acute severe ulcerative colitis (ASUC)**.
The patient has been diagnosed with **ulcerative colitis**, and this diagnosis has been confirmed through a test called **pathology**.
The patient is between 18 and 75 years old at the time of the first infliximab infusion.
The patient understands Dutch and/or English well.
The patient has been admitted to the hospital with a diagnosis of ASUC, defined by specific criteria known as the **Truelove and Witts’ criteria**.
The patient is currently hospitalized.
The patient did not respond to a treatment called **intravenous steroid treatment**, as defined by the **Oxford criteria** (more than 8 stools per day or 3-8 stools per day and a **CRP** level of 45 or higher) and a **Lichtiger score** of 10 or more on day 3 (plus or minus 2 days) after starting the intravenous steroid treatment.
The patient has not received a type of treatment called **anti-tumor necrosis factor therapy** before.
The patient will receive infliximab as a rescue treatment for this episode of acute severe ulcerative colitis.

Who cannot join the trial?

4 criteria

Patients who do not have acute severe ulcerative colitis. This is a serious condition where the colon becomes inflamed and causes severe symptoms.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population. This means people who might need special protection or care.
Patients who do not meet other specific health criteria set by the study. These criteria ensure the safety and effectiveness of the treatment being tested.

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Verified sites

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Katholieke Universiteit te Leuven
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Leuven, Belgium

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Investigated drugs

Infliximab is a medication used in this study to treat patients with acute severe ulcerative colitis who do not respond to steroid treatments. It works by blocking a specific protein in the body that causes inflammation, helping to reduce symptoms and improve the condition. The study aims to explore how well infliximab can be dosed precisely for each patient to achieve the best results.

Infliximab

What is already known about the treatment

Infliximab – Infliximab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently used in medicine to treat various inflammatory conditions, and it is well-documented in medical literature. The main therapeutic indication for infliximab in this context is acute severe ulcerative colitis, particularly when patients do not respond to steroids. At the molecular level, infliximab works by blocking a protein called tumor necrosis factor-alpha (TNF-alpha), which plays a key role in causing inflammation. It is classified as a monoclonal antibody, which is a type of biological therapy designed to target specific molecules in the body.

Investigated diseases

Acute Severe Ulcerative Colitis – This is a sudden and intense inflammation of the colon, which is part of the digestive system. It is characterized by frequent, urgent bowel movements that may contain blood, along with abdominal pain and cramping. The disease can lead to significant discomfort and may cause dehydration due to diarrhea. It often requires immediate medical attention to manage symptoms and prevent complications. The inflammation can affect the entire colon or just parts of it, leading to varying degrees of severity. The condition can fluctuate, with periods of intense symptoms followed by times of remission.