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Study on Infliximab for Children with Crohn's Disease

Verified siteRegistered drugNo placebo
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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 studying Inflammatory Bowel Disease (IBD) in children, specifically looking at a condition called Crohn's Disease. The treatment being tested is a medication called Infliximab, which is given as an infusion, meaning it is administered directly into the bloodstream through a vein. The purpose of the study is to understand how well this medication works in maintaining certain levels in the blood without needing to increase the treatment.

Participants in the study will receive Infliximab and will be monitored over a period of time to see how their bodies respond to the treatment. The study will check the levels of the medication in the blood at different times, specifically at weeks 4, 12, and 24. The goal is to see if the medication can help keep the disease under control without needing to change the treatment plan.

Throughout the study, researchers will also look at how many participants are in remission, which means their symptoms are reduced or gone, at various points in time. This will help determine if Infliximab is effective in managing Crohn's Disease in children. The study aims to provide valuable information on the use of this medication in young patients with this condition.

The research process

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

  1. Step 1

    Joining the study

    Participation begins after a diagnosis of Crohn's Disease is confirmed based on specific criteria. Eligibility includes children aged 1-15 years who have not previously received anti-TNF-α treatment and have an indication to start infliximab treatment.

  2. Step 2

    Initial treatment

    The treatment involves the administration of infliximab, a medication given through an intravenous infusion. The product used is called Remsima 100 mg powder for concentrate for solution for infusion.

  3. Step 3

    Monitoring and assessment at week 4

    At week 4, the proportion of patients in clinical and/or biochemical remission is assessed. This involves checking the levels of infliximab in the blood and evaluating the patient's response to the treatment.

  4. Step 4

    Monitoring and assessment at week 12

    At week 12, the primary goal is to determine the proportion of patients with infliximab levels of at least 5 micrograms per milliliter without the need for increasing the treatment dose. This is a key point in the study to evaluate the effectiveness of the treatment.

  5. Step 5

    Monitoring and assessment at week 24

    At week 24, the study assesses the proportion of patients who maintain infliximab levels of at least 5 micrograms per milliliter without increasing the treatment dose. Additionally, the study evaluates the proportion of patients in clinical and/or biochemical remission.

  6. Step 6

    Completion of the study

    The study is expected to conclude by August 2, 2025. Throughout the study, the effectiveness and safety of infliximab treatment in children with Crohn's Disease are closely monitored.

Who can join the trial?

6 criteria

  • The study is for children who have never been treated with **Anti-TNF-α** medications. These are drugs used to reduce inflammation in the body.
  • Participants should be between the ages of 1 and 15 years old.
  • Children must have a diagnosis of **Crohn's Disease (CD)** or **Inflammatory Bowel Disease Unclassified (IBD-U)**. These are conditions that cause inflammation in the digestive tract.
  • There must be a medical reason to start treatment with **IFX** (Infliximab), a medication used to treat inflammation. This decision is made by the child's doctor.
  • Reasons to start IFX treatment include not responding to initial treatments like special diets or steroids, not responding to other medications that modify the immune system, severe growth problems, or having a widespread or complicated form of the disease.
  • Both boys and girls can participate in the study.
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Investigated drugs

Infliximab is a medication used in this clinical trial. It is a type of drug known as a biologic, which is used to treat inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. Infliximab works by blocking a protein in the body called tumor necrosis factor (TNF), which plays a role in causing inflammation. By reducing inflammation, Infliximab helps to relieve symptoms and improve the quality of life for patients with these conditions. In this trial, the focus is on understanding how the drug behaves in the body of pediatric patients and ensuring that the levels of the drug remain effective over time without needing to increase the dose.

What is already known about the treatment

Infliximab – Infliximab is administered intravenously, typically in a hospital or clinical setting. It is currently well-established in medical literature as a treatment for inflammatory conditions, particularly Crohn's Disease. The main therapeutic indication for infliximab is to reduce inflammation and manage symptoms in patients with Crohn's Disease. At the molecular level, infliximab works by binding to and inhibiting tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. It is classified as a monoclonal antibody and is part of the biologic drug category.

Investigated diseases

Crohn's Disease – Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract. It can affect any part of the digestive system, from the mouth to the anus, but most commonly impacts the end of the small intestine and the beginning of the colon. The inflammation caused by Crohn's Disease can lead to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The disease can progress in a series of flare-ups and remissions, where symptoms may worsen and then improve. Over time, the inflammation can cause complications like strictures, fistulas, and abscesses. The exact cause of Crohn's Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-507352-72-00Protocol codeNL81536.078.22Estimated enrolment50 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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