Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents
This study is investigating a new oral medicine called filgotinib for children and teenagers between 8 and 18 years old who have polyarticular-course juvenile idiopathic arthritis (JIA). This type of JIA affects many joints and hasn't improved enough with usual treatments. The main goal is to understand how safe the medicine is and if people can take it without too many side effects (this is called tolerability). Researchers will also check how the medicine works in the body and if it helps to improve arthritis symptoms. Participants will take the medicine for up to 18 weeks, and the study is open-label, meaning everyone involved will know what treatment is being given.
Överblick
Vad handlar denna studie om?
This study is focused on a health condition called juvenile idiopathic arthritis (JIA), which is a type of arthritis affecting children and teenagers. Specifically, it's for those with 'polyarticular-course' JIA, meaning it affects five or more joints. While there are treatments available for JIA, some young people don't get enough relief from their symptoms, or they can't tolerate the existing medicines. This study is exploring a new oral medication called filgotinib, hoping it could be another option.
The main purpose of this research is to see if filgotinib is safe and well-tolerated when given to young people with this specific type of JIA. This means carefully watching for any side effects and how easily participants can take the medicine. Researchers will also be looking at how the medicine moves through the body and, importantly, if it can help reduce the pain, swelling, and stiffness in their joints. The study aims to gather important information that could potentially lead to a new treatment for JIA.
Taking part in a study like this helps doctors learn more about diseases and find better ways to treat them. By understanding how filgotinib works in children and teenagers, doctors can make more informed decisions about future treatment options for JIA. It's an important step in trying to improve the quality of life for young people living with this condition.
Viktiga punkter
- This study is for children and teenagers (8-18 years old) with a type of arthritis called polyarticular-course JIA.
- It's testing a new oral medicine called filgotinib to see if it's safe and helps improve symptoms.
- Participants will know they are receiving filgotinib and will take it for up to 18 weeks.
- Regular health checks and follow-up visits will be part of the study.
- Participation is voluntary, and you can leave the study at any time.
Vem kan vara berättigad?
To join this study, you need to be a boy or girl aged between 8 and 18 years old. You must have a type of arthritis called polyarticular-course juvenile idiopathic arthritis (JIA) that affects many joints and hasn't responded well enough to other treatments. This means your current medicines, such as methotrexate or other similar arthritis drugs, haven't fully controlled your symptoms, or you've experienced difficulties with them. You also need to be willing to follow all the study instructions and attend appointments.
There are also some reasons why you might not be able to join. For example, if you weigh less than 15 kilograms, or if you have a different type of JIA (like systemic JIA or persistent oligoarthritis that only affects a few joints). If you have certain other serious health problems, active eye inflammation (uveitis), or if you're already involved in another clinical trial, you wouldn't be able to participate. The study team will check all these details carefully to make sure it's safe for you to take part.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Am I aged between 8 and 18 years old?
- Do I have polyarticular-course juvenile idiopathic arthritis (affecting many joints)?
- Have my current JIA medicines not worked well enough, or have I had trouble taking them?
- Do I weigh at least 15 kilograms?
- Do I not have other specific types of JIA or certain serious health problems?
- Am I able to attend regular clinic visits and follow study instructions?
Vad innebär deltagande?
If you join this study, you will be taking the study medicine, filgotinib, by mouth for up to 18 weeks. This is called an "open-label" study, which means everyone involved – you, your family, and the study team – will know you are receiving filgotinib. During this period, you will have regular visits to the clinic so the doctors can check your health, see how you are responding to the medicine, and monitor for any side effects. These visits will involve various checks, possibly including blood tests, physical examinations, and questions about your symptoms and how you are feeling. After the 18 weeks of treatment, there will also be follow-up appointments to continue monitoring your health. The total duration of your involvement will therefore include the treatment period and follow-up, which the study team will explain in detail.
Potentiella risker och fördelar
Platser (14)
- UZ LeuvenVerifierat postnummerLeuven, Belgien· Rekrytering
- Vseobecna fakultni nemocnice v PrazeVerifierat postnummerPrag, Tjeckien· Rekrytering
- Hôpital BicêtreVerifierat postnummerLe Kremlin-Bicêtre, Frankrike· Rekrytering
- Charité - Campus Virchow-KlinikumVerifierat postnummerBerlin, Tyskland· Rekrytering
- Hamburger Zentrum fuer Kinder und JugendrheumatologieVerifierat postnummerHamburg, Tyskland· Rekrytering
- Pecsi Tudomanyegyetem Klinikai KozpontVerifierat postnummerPécs, Hungary· Rekrytering
- Istituto Giannina Gaslini-Ospedale Pediatrico IRCCSVerifierat postnummerGenova, Italy· Rekrytering
- Centrum Medyczne Hipokrates S C Elzbieta I Grzegorz GrzeskVerifierat postnummerBydgoszcz, Poland· Rekrytering
- MICS Centrum Medyczne TorunVerifierat postnummerTorun, Poland· Rekrytering
- ETG JustMedVerifierat postnummerWarszawa, Polen· Rekrytering
- Sjukhus Sant Joan de DeuVerifierat postnummerBarcelona, Spanien· Rekrytering
- Bristol Kungliga BarnsjukhusVerifierat postnummerBristol, Storbritannien· Rekrytering
Vanliga frågor
What is filgotinib?
Filgotinib is a new oral medicine being studied to see if it can help treat polyarticular-course juvenile idiopathic arthritis (JIA).
What does 'polyarticular-course' JIA mean?
This means your juvenile idiopathic arthritis affects many joints – typically five or more – throughout the course of the illness.
Will I know if I'm getting the real medicine or a dummy pill?
In this specific study, everyone who participates will receive the study medicine, filgotinib. It's an 'open-label' study, so you will know what you are taking.
Hur länge kommer studien att pågå för mig?
You will take the study medicine for up to 18 weeks, followed by a period of follow-up visits to check your health. The total duration will be explained by the study team.
Kan jag lämna studien om jag ändrar mig?
Yes, absolutely. Your participation is voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your medical care.
Hur du får reda på mer
Medical Information
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
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Diskussion
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