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A study to evaluate the safety and effectiveness of filgotinib in children and adolescents with juvenile idiopathic arthritis.

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What is this trial about?

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

This study focuses on Juvenile Idiopathic Arthritis, which is a type of chronic arthritis—a condition involving inflammation and swelling of the joints—that affects children and adolescents. The investigation aims to determine the long-term safety and how well the body handles the medication filgotinib, which is also known by the brand name Jyseleca. The treatment is administered as an oral medication, meaning it is taken by mouth in the form of film-coated tablets.

The study is an open-label extension, which means that all participants know which medication they are receiving during this phase. Participants will continue to take the medication over an extended period to monitor for any adverse events, which are unexpected or unpleasant side effects. The research also looks at the occurrence of uveitis, an inflammation that can happen inside the eye, to ensure the treatment is safe for long-term use in young people.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of the <b>open-label extension</b>
The study begins after the completion of previous parent studies for juvenile idiopathic arthritis, which is a type of chronic joint inflammation in children and adolescents.
The open-label extension means that the treatment being used is known to both the patient and the medical staff.
Step 2
Medication administration
The medication filgotinib is taken by mouth using film-coated tablets.
The specific dose of filgotinib provided may be 100 mg or 200 mg per administration.
Step 3
Monitoring and evaluation
During the study, the safety and how well the body tolerates the medication are monitored.
Health assessments are conducted at each visit to track adverse events, which are any side effects or unexpected medical issues that occur during treatment.
The effectiveness of the medication is evaluated based on clinical remission, which is a state where the symptoms of juvenile idiopathic arthritis are minimal or absent, and inactive disease, where the inflammation is controlled.
The condition of the eyes is monitored to check for uveitis, which is inflammation inside the eye.

Who can join the trial?

4 criteria

The person must have finished taking the medicine filgotinib in a previous related study and must have seen an improvement in their condition by the end of that study.
The person must be between 8 and 17 years old (not yet 18) at the time they sign the paperwork.
The person and their parent or legal guardian must be willing to follow all the rules of the study and must sign informed consent, which is a document explaining the study details, and assent, which is a child's agreement to participate.
Female participants who are capable of becoming pregnant and are sexually active must agree to use contraception, which means using methods like birth control to prevent pregnancy, as explained in the study rules.

Who cannot join the trial?

5 criteria

You developed a new medical condition during the previous study that would make it unsafe for you to continue taking the medication.
You are pregnant.
You have an active infection, which is an illness caused by germs like bacteria or viruses, that is serious enough to be noticed by the doctor.
You have a known hypersensitivity, which means an allergy or an unusually strong reaction, to any of the ingredients used in the study medicine.
You have any other health issues or abnormalities in laboratory parameters, which means your blood tests or other medical tests show results that are not in the normal range, that might make it difficult for you to finish the study or follow the study rules.

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Verified sites

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Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
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Katholieke Universiteit te Leuven
Leuven, Belgium
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Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

Filgotinib is an oral medication being studied to see how safe and effective it is for children and teenagers with juvenile idiopathic arthritis. It works by helping to manage the symptoms of this type of arthritis in young patients.

Filgotinib

What is already known about the treatment

Filgotinib - This medication is taken by mouth in the form of small, coated tablets. It is currently being studied for its long-term safety and effectiveness in children and adolescents with juvenile idiopathic arthritis. As a type of targeted medicine called a JAK inhibitor, it works by blocking specific proteins inside immune cells that trigger swelling and pain. By stopping these signals, the drug helps to calm an overactive immune system and reduce joint inflammation.

Investigated diseases

Juvenile idiopathic arthritis - This condition involves chronic inflammation of the joints in children and adolescents. The immune system mistakenly attacks healthy joint tissues, leading to swelling and pain. Over time, the inflammation can cause stiffness and affect the movement of the affected areas. Some forms of this disease may also involve inflammation in other parts of the body, such as the eyes. The symptoms can vary in intensity and may change as the person grows.