An open-label, multiple dose, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of filgotinib in children and adolescents from 8 to less than 18 years of age with juvenile idiopathic arthritis
Juvenile idiopathic arthritis causes painful, swollen, and stiff joints in children and teenagers. This clinical trial is testing a medicine called filgotinib (also known by the brand name Jyseleca). Filgotinib is already used for adults with joint conditions, but researchers need to know how it works in younger people. The study involves children and teenagers aged 8 to 17. Doctors want to see how the body absorbs, breaks down, and clears the medicine. They also want to check for any unwanted side effects and find out how easy the tablets or mini-tablets are to take. Taking part helps doctors understand the right dose of filgotinib for young people. This could help improve future treatments for children living with arthritis.
Auf einen Blick
Worum geht es in dieser Studie?
Juvenile idiopathic arthritis, often shortened to JIA, is a condition that causes inflammation in the joints of children and teenagers. It can lead to joint pain, swelling, and stiffness, making daily activities like walking, writing, or playing sport difficult. While there are treatments available today, doctors are always looking for new options to help young people manage their symptoms better.
This study focuses on an anti-inflammatory medicine called filgotinib (brand name Jyseleca). Filgotinib works by calming down parts of the immune system that cause joint swelling. It is already approved for use in adults with certain inflammatory conditions, but children's bodies process medicines differently than adults do. Because of this, doctors cannot simply guess the right amount to give.
In this trial, researchers are studying what happens to filgotinib once it enters a young person's body. They will measure how much of the medicine gets into the blood and how long it stays there. They will also keep a very close eye on safety, checking whether the medicine causes any side effects, and ask participants how easy the tablets are to swallow. The findings will help doctors work out safe and effective doses for children in the future.
Wichtige Erkenntnisse
- The trial looks at the medicine filgotinib in young people aged 8 to 17 with arthritis.
- Researchers are testing how the body handles the medicine and checking for side effects.
- Everyone in this study receives the active medicine; there is no placebo.
- Participants will need regular clinic visits and blood tests to monitor medicine levels.
- Taking part is completely voluntary and you can stop at any time.
Wer könnte berechtigt sein?
This trial is designed for children and young people between the ages of 8 and 17 who have been diagnosed with juvenile idiopathic arthritis. Both boys and girls can take part.
Because this is an early-stage study to check medicine levels, participants will need to be able to swallow tablets or mini-tablets and be willing to have regular blood tests.
Not everyone with arthritis will be able to join. The study team will need to check your general health, medical history, and any other medications you are currently taking to ensure it is safe for you to take part.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Are you between 8 and 17 years old?
- Have you been diagnosed with juvenile idiopathic arthritis (JIA)?
- Are you able to swallow tablets or mini-tablets?
- Are you comfortable having regular clinic checks and blood tests?
- Are you and your parent or guardian happy to attend hospital visits?
Was beinhaltet die Teilnahme?
If you decide to take part, you will be given filgotinib to take by mouth as a tablet or mini-tablet. The study is 'open-label', which means both you and your doctors will know that you are receiving the real medicine rather than a dummy pill (placebo).
You will need to attend a hospital or clinic for regular study visits. During these visits, doctors and nurses will check your general health, measure your blood pressure, and take blood samples. These blood tests are very important because they show how much medicine is in your bloodstream at different times of the day.
You and your parents or carers will also be asked to fill in short surveys about what it is like taking the tablets, such as whether they are easy to swallow. The study team will explain exactly how long you will take the medicine and how many clinic visits will be needed before you agree to join.
Potenzielle Risiken und Vorteile
Standorte (4)
- —UnbestätigtFrankreich
- —UnbestätigtDeutschland
- —UnbestätigtPolen
- —UnbestätigtSpanien
Häufige Fragen
What is filgotinib?
Filgotinib is a daily tablet that helps reduce swelling and pain by calming down an overactive immune system.
Will I receive a dummy pill (placebo)?
No. This is an open-label trial, which means everyone who takes part receives the active study medicine.
Why do you need blood tests?
Blood tests show the researchers how quickly the medicine enters your body and how long it stays in your blood.
What happens if I find the tablets hard to swallow?
The study tests both regular tablets and smaller mini-tablets. You will be asked to give your honest feedback on how easy they are to take.
Kann ich die Studie verlassen, wenn ich meine Meinung ändere?
Yes. You can leave the study at any point, and your usual medical team will continue to care for you as normal.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
Interessiert daran, teilzunehmen?
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