A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
This research study is looking into a new medicine, ixekizumab, for children and young people aged 2 to 17. It's for those with two specific types of juvenile arthritis: enthesitis-related arthritis (which includes a type of arthritis that can affect the spine called juvenile onset ankylosing spondylitis) and juvenile psoriatic arthritis. The main goal is to find out if ixekizumab is safe for these children and if it works well to help manage their arthritis symptoms. To understand its effects, we will be comparing it to another medicine, adalimumab, which is often used for these conditions. This is a Phase 3 study, meaning it's one of the final steps before a medicine might become more widely available.
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Resultados
Resultados de este estudio
Publicado Junio 2025Se han publicado los resultados de este estudio.
¿De qué trata este estudio?
Imagine you have persistent joint pain, swelling, or stiffness, especially in places where tendons or ligaments attach to bones, or along with skin problems. This is a reality for children and young people with certain types of juvenile arthritis. This study focuses on two specific kinds: enthesitis-related arthritis and juvenile psoriatic arthritis. These conditions can be very challenging, affecting daily life, school, and play, and they can sometimes lead to long-term problems if not managed well. Current treatments help manage the symptoms, but researchers are always looking for even better options that are safe and effective for children.
That's where this study comes in. We want to explore a new medicine called ixekizumab. This medicine works by targeting specific parts of the immune system that cause inflammation in these arthritis conditions. By doing so, it aims to reduce pain, swelling, and other symptoms, helping children feel better and improve their overall health and well-being.
We will be comparing ixekizumab with another medicine called adalimumab, which is already used for these conditions. This comparison helps doctors understand if ixekizumab is as good as, or perhaps even better than, existing treatments. The information gathered from studies like this is crucial for doctors to make informed decisions about the best ways to treat children with these challenging forms of arthritis in the future.
Puntos clave
- Study for children aged 2-17 with specific types of juvenile arthritis.
- Testing a new medicine, ixekizumab, against an existing one, adalimumab.
- Aims to check if ixekizumab is safe and effective in reducing arthritis symptoms.
- Involves regular clinic visits and close health monitoring.
- La participación es voluntaria, y puedes retirarte en cualquier momento.
¿Quién puede ser elegible?
This study is looking for children and young people between the ages of 2 and 17 years old. To join, they must have either active enthesitis-related arthritis (which sometimes includes juvenile onset ankylosing spondylitis) or active juvenile psoriatic arthritis. They also need to weigh at least 10 kilograms. If they have juvenile psoriatic arthritis, they must be at least 2 years old, and if they have enthesitis-related arthritis, they must be at least 6 years old. It's also important that all their routine childhood vaccinations are up-to-date, as advised by your doctor.
There are also some reasons why someone might not be able to join the study. For example, if they have certain other health problems like inflammatory bowel disease, an active eye condition called uveitis, or an active infection. They also cannot have ever had or currently have tuberculosis. If your child is already taking certain types of biological medicines for their arthritis, they wouldn't be able to join this study either.
The research team will carefully check all these requirements to make sure the study is a good fit for your child and that it would be safe for them to take part.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Is your child aged between 2 and 17 years old?
- Does your child have active enthesitis-related arthritis or juvenile psoriatic arthritis?
- ¿Su hijo pesa al menos 10 kilogramos?
- Are your child's routine vaccinations up-to-date?
- Does your child currently NOT have any active infections or other specific serious health conditions mentioned by the study team?
¿En qué consiste la participación?
Taking part in this study would involve regular visits to the clinic over a period of time. During these visits, the study team would perform various assessments to check your child's health and how their arthritis is responding to the treatment. This might include physical examinations, blood tests, and potentially other tests related to their arthritis. Your child would receive either the new study medicine, ixekizumab, or the comparison medicine, adalimumab. The treatments are usually given as an injection. The study team would explain exactly how and when to give the medicine. Throughout the study, the team would closely monitor your child for any side effects and to see how their arthritis symptoms are changing. After the main treatment period, there will be follow-up visits to continue to monitor their health. The total time your child would be involved in the study would depend on the specific study plan, which the research team would discuss with you in detail.
Riesgos y beneficios potenciales
Locations (43)
- Instituto CAICI SRL Loc. 15Código postal verificadoRosario, Argentina
- Centro Medico Privado de Reumatologia Loc. 20Código postal verificadoSan Miguel de Tucumán, Argentina
- Cliniques universitaires Saint-LucCódigo postal verificadoBruselas, Bélgica
- UZ GentCódigo postal verificadoGante, Bélgica
- UZ LeuvenCódigo postal verificadoLovaina, Bélgica
- Oddeleni revmatologie deti a dospelych Loc. 1Código postal verificadoPraga, Chequia
- Dětská klinika Loc. 11Código postal verificadoOlomouc, Czechia
- Klinika detskeho a dorostoveho lekarstvi Loc. 1Código postal verificadoPraga, Chequia
- Aarhus Universitetshospital, SkejbyCódigo postal verificadoAarhus, Denmark
- Service rhumatologie Loc.Código postal verificadoBron, Francia
- Service de consultation pédiatrique Loc. 1Código postal verificadoMontpellier, Francia
- Rhumatologie pediatrique et CEREMAIA Loc. 1Código postal verificadoLe Kremlin-Bicêtre, France
Preguntas comunes
What is juvenile idiopathic arthritis?
Juvenile idiopathic arthritis (JIA) is a type of long-term arthritis that affects children and young people under the age of 16. It causes joint pain, swelling, and stiffness.
What are enthesitis-related arthritis and juvenile psoriatic arthritis?
These are two specific types of juvenile idiopathic arthritis. Enthesitis-related arthritis mainly affects places where tendons and ligaments attach to bones, while juvenile psoriatic arthritis occurs in children who also have a skin condition called psoriasis.
What is ixekizumab?
Ixekizumab is a new medicine being tested. It works by calming down parts of the immune system that cause inflammation in arthritis, aiming to reduce pain and swelling.
What is adalimumab?
Adalimumab is an existing medicine commonly used to treat certain types of arthritis, including some forms of juvenile idiopathic arthritis. It also works by affecting the immune system.
Will my child definitely get the new medicine?
This is a comparison study, so your child might receive either ixekizumab (the new medicine) or adalimumab (an existing medicine). The study team will explain how this is decided.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.