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Study on the Effectiveness of Infliximab for Children with Inflammatory Bowel Disease

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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 the effects of a medication called Infliximab on children and adolescents with Inflammatory Bowel Disease (IBD). Inflammatory Bowel Disease is a condition that causes inflammation in the digestive tract, leading to symptoms like stomach pain, diarrhea, and weight loss. The study aims to understand how well Infliximab works and how long its effects last when used early in treatment.

Participants in the study will receive Infliximab, which is given as a solution through an infusion, meaning it is administered directly into the bloodstream. The study will compare two different approaches to using Infliximab: one group will receive the medication according to a standard schedule, while the other group will have their treatment adjusted based on regular monitoring of the drug levels in their blood. This approach is known as proactive therapeutic drug monitoring.

The study will last for about a year, during which time researchers will observe how the treatment affects the participants' health. They will look at factors such as whether the medication needs to be stopped due to side effects or if the treatment needs to be intensified because it is not working as expected. The goal is to find out if adjusting the treatment based on drug levels can improve the effectiveness and durability of Infliximab in treating IBD in young patients.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the criteria for participation.

  3. Step 3

    First infusion

    You will receive your first dose of infliximab through an infusion. This is a process where the medication is slowly administered into your bloodstream through a vein. The dosage and frequency will be determined by the study protocol.

  4. Step 4

    Regular monitoring

    Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes blood tests and other assessments to check for any side effects or changes in your condition.

  5. Step 5

    Subsequent infusions

    You will receive additional infusions of infliximab at scheduled intervals. The frequency and duration of these infusions will be based on the study's requirements.

  6. Step 6

    Mid-trial evaluation

    A mid-trial evaluation will be conducted to assess the effectiveness of the treatment. This may involve additional tests and assessments to determine if any adjustments to your treatment plan are necessary.

  7. Step 7

    Final assessment

    At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on your condition. This will include a comprehensive review of your health status and any changes observed during the trial.

  8. Step 8

    Follow-up

    After the trial concludes, follow-up appointments may be scheduled to monitor your health and ensure any long-term effects of the treatment are addressed.

Who can join the trial?

5 criteria

  • Children and teenagers aged 6 to 17 years old.
  • Have a confirmed diagnosis of Inflammatory Bowel Disease (IBD) through a previous test called an endoscopic biopsy.
  • Have not been treated with anti-TNF medications before. Anti-TNF medications are drugs used to reduce inflammation in the body.
  • Need to start anti-TNF therapy as recommended by current guidelines for treating IBD in children.
  • Have active inflammation, shown by a blood test result of CRP greater than 5 mg/L or a stool test result of FC greater than 150 µg/g before the first dose of the medication IFX. CRP and FC are markers that indicate inflammation in the body.

Who cannot join the trial?

14 criteria

  • Patients with any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of allergic reactions to the study medication or similar medications.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of liver or kidney disease.
  • Patients who have a history of blood disorders.
  • Patients who have a history of mental health disorders that are not well controlled.
  • Patients who are unable to comply with the study procedures or follow-up visits.
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Investigated drugs

Infliximab is a medication used to treat inflammatory bowel disease, which includes conditions like Crohn's disease and ulcerative colitis. It works by blocking a protein in the body called tumor necrosis factor-alpha (TNF-alpha), which is involved in causing inflammation. By reducing inflammation, infliximab helps to relieve symptoms such as pain and diarrhea, and it can help the intestines heal. In this trial, the focus is on how well infliximab works over time and whether monitoring its levels in the blood can improve its effectiveness and durability in children with these conditions.

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 well-established in medical practice and literature, particularly for treating inflammatory bowel disease (IBD). The main therapeutic use of infliximab is to reduce inflammation in conditions like Crohn's disease and ulcerative colitis, which are types of IBD. 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 biologic medication, specifically a monoclonal antibody, which targets specific components of the immune system to reduce inflammation.

Investigated diseases

Inflammatory Bowel Disease – Inflammatory Bowel Disease (IBD) is a term primarily used to describe two conditions: Crohn's Disease and Ulcerative Colitis. These conditions involve chronic inflammation of the gastrointestinal tract. In Crohn's Disease, inflammation can occur anywhere along the digestive tract, often affecting deeper layers of the bowel wall. Ulcerative Colitis, on the other hand, is limited to the colon and rectum, with inflammation typically affecting only the innermost lining of the colon. Symptoms of IBD can include persistent diarrhea, abdominal pain, rectal bleeding, weight loss, and fatigue. The progression of IBD can vary, with periods of active symptoms (flare-ups) and periods of remission.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-517759-11-00Protocol codeEPIC StudyEstimated enrolment86 patientsSponsorIstituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo

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