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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo	Trieste	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Akkcglr Omocuduhqfb Ptnj Gjdrjbnd Xbdtc	Bergamo	Italy
Ulgentglgm Dzkiz Sscud Dy Rgte Lr Simdowav	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	09.03.2022

Trial locations

Investigated drugs:

Infliximab

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.

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 ID:

2024-517759-11-00

Protocol code:

EPIC Study

NCT ID:

NCT05280405

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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