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Study on the Effectiveness and Safety of Golimumab for Children with Moderate to Severe Ulcerative Colitis

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 the effects of a medication called golimumab in children with a condition known as ulcerative colitis. Ulcerative colitis is a disease that causes inflammation and sores in the lining of the large intestine, which can lead to symptoms like abdominal pain and diarrhea. The medication being tested, golimumab, is a type of treatment known as a monoclonal antibody, which is designed to help reduce inflammation by targeting a specific protein in the body. In this study, golimumab is administered as an injection under the skin using either a pre-filled syringe or a pre-filled pen.

The purpose of the study is to evaluate how effective and safe golimumab is for treating children with moderate to severe ulcerative colitis. Participants in the study will receive the medication over a period of time, and their health will be monitored to see if their symptoms improve. The study will also look at how the body processes the medication, which is known as pharmacokinetics. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of golimumab.

Throughout the study, doctors will use a scoring system called the Mayo score to assess the severity of the disease and determine if the treatment is helping. The study will also check for any side effects to ensure the safety of the participants. The goal is to see if golimumab can help children achieve remission, which means their symptoms are reduced or disappear, and to understand its safety profile in this group.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current treatments for ulcerative colitis.
Eligibility criteria include a history of treatment with certain medications or a medical contraindication to them, and a specific level of disease activity as measured by the Mayo score.
Step 2
Treatment initiation
The treatment involves the administration of golimumab, a medication given by injection under the skin.
The medication is available in different forms: a 50 mg solution in a pre-filled syringe, a 45 mg/0.45 mL solution in a pre-filled pen, and a 100 mg solution in a pre-filled syringe.
Step 3
Treatment administration
The medication is administered subcutaneously, which means it is injected under the skin.
The frequency and dosage of the medication are determined based on the specific needs and response of the participant.
Step 4
Monitoring and evaluation
Throughout the study, regular monitoring is conducted to assess the effectiveness and safety of the treatment.
The primary goal is to achieve clinical remission, which is evaluated using the Mayo score, a tool used to measure disease activity in ulcerative colitis.
Step 5
Study completion
The study is expected to continue until December 31, 2025.
Upon completion, the results will be analyzed to determine the overall efficacy and safety of golimumab in treating pediatric participants with moderately to severely active ulcerative colitis.

Who can join the trial?

5 criteria

The patient must be currently receiving treatment with, or have a history of not responding to, or have a medical reason not to use at least one of the following treatments: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate, or azathioprine. Alternatively, the patient must have a history of being dependent on corticosteroids, meaning they cannot reduce the use of corticosteroids without the symptoms of **ulcerative colitis** returning, or have needed more than three courses of corticosteroids in the past year.
The patient must have **moderately to severely active ulcerative colitis**, which is determined by a specific score called the Mayo score, ranging from 6 to 12. This score includes a part that is assessed through a procedure called endoscopy, which involves looking inside the colon.
If the patient is receiving nutrition through a method other than eating, such as through a tube or directly into the bloodstream, they must have been on a stable nutrition plan for at least two weeks before starting the study. Patients receiving nutrition directly into the bloodstream cannot join the trial.
The patient must have no history of **latent** (hidden) or active **tuberculosis** before the screening for the study.
The patient must have acceptable proof of immunity to **measles**, **mumps**, **rubella**, and **varicella** (chickenpox).

Who cannot join the trial?

9 criteria

Patients who have a different condition than Ulcerative Colitis cannot participate. Ulcerative Colitis is a condition that causes inflammation and sores in the colon and rectum.
Patients who are not within the specified age range for the study cannot participate. The study is for pediatric participants, which means children and teenagers.
Patients who are not experiencing moderate to severe symptoms of Ulcerative Colitis cannot participate. This means the condition must be significantly affecting their health.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other health conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
Patients who are currently participating in another clinical trial cannot participate in this study.
Patients who have had certain treatments or medications recently that might affect the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have a history of certain infections or diseases that could affect their safety during the study cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Casa Sollievo Della Sofferenza
Verified
San Giovanni Rotondo, Italy
Copernicus Podmiot Leczniczy Sp. z o.o.
Verified
Gdansk, Poland
Hopital Necker Enfants Malades
Verified
Paris, France

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Investigated drugs

Golimumab is a medication used in this clinical trial. It is a human monoclonal antibody that targets and blocks a protein called TNF-alpha. This protein is involved in causing inflammation in the body. By blocking TNF-alpha, golimumab helps reduce inflammation and is used to treat conditions like ulcerative colitis, which is a type of inflammatory bowel disease. In this trial, golimumab is given to pediatric participants with moderately to severely active ulcerative colitis to see if it can help them achieve clinical remission, meaning their symptoms improve significantly or disappear. The trial also aims to assess the safety of golimumab in these young patients.

Golimumab

What is already known about the treatment

Golimumab – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating pediatric patients with moderately to severely active ulcerative colitis. Golimumab is primarily used to help achieve clinical remission in these patients. It works by targeting and neutralizing tumor necrosis factor-alpha (TNFα), a substance in the body that causes inflammation, thereby reducing symptoms of the disease. Golimumab is classified as a human monoclonal antibody and is part of the anti-TNFα drug class.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of flare-ups and remissions. During flare-ups, symptoms can become more severe, while remissions may bring relief. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response. The condition can significantly impact daily life and requires ongoing management.