A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
This study is about a medicine called baricitinib for children and young people aged 1 to 17 who have Juvenile Idiopathic Arthritis (JIA). JIA is a condition where a child's immune system mistakenly attacks their joints, causing pain and swelling. The study aims to see if baricitinib is safe and effective in treating JIA in this age group. All participants in this study would have already taken part in a previous study testing baricitinib for JIA. This means researchers already have some information about how the medicine might work for them. The goal is to gather more details about the long-term safety and benefits of baricitinib for children and teenagers with JIA.
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¿De qué trata este estudio?
This study is designed to understand more about a medicine called baricitinib for children and young people with Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that affects children, causing their joints to become swollen, painful, and stiff. It's a long-term condition that can make everyday activities difficult for children.
The researchers want to make sure that baricitinib is both safe to use and effective in helping to treat JIA in young patients between 1 and 17 years old. This is a very important step in finding the best ways to manage JIA and improve the lives of children affected by it.
What makes this study a bit different is that all the children taking part have already been involved in an earlier study looking at baricitinib for JIA. This follow-up study allows the doctors and scientists to continue observing how baricitinib works over a longer time. They can gather more information on its effects and how well children tolerate the medicine. This is known as a "Phase 3" study, which means it's one of the final steps before a new medicine might become widely available.
Puntos clave
- This study is for children aged 1-17 with JIA.
- It's testing a medicine called baricitinib for safety and effectiveness.
- Participants must have already been in a previous baricitinib study for JIA.
- The study helps gather more information on long-term treatment.
- Your child will have regular check-ups during the study.
¿Quién puede ser elegible?
To be able to join this study, a child must have already taken part in a previous study investigating baricitinib for their JIA. This is an important requirement, as the researchers are looking to continue gathering information on participants who have already started treatment.
There are also some reasons why a child couldn't join. For instance, if they had to stop taking baricitinib permanently during the earlier study, they wouldn't be able to participate. Also, if a child developed an allergic reaction to baricitinib in the previous study, they would not be able to join this one.
¿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 1 and 17 years old?
- Has your child previously taken part in a study for baricitinib for JIA?
- Did your child continue taking baricitinib throughout that previous study (not permanently stopped)?
- Has your child not developed an allergy to baricitinib?
¿En qué consiste la participación?
If you decide to take part in this study, your child will continue to receive the study medicine, baricitinib. You would need to attend regular clinic visits where doctors and nurses will check how your child is doing, how the medicine is affecting their JIA, and if they are experiencing any side effects. These visits might include physical examinations, blood tests, and discussions about your child's health.
The exact number and timing of visits will be explained by the study team, but they are designed to closely monitor your child's health and the effects of the treatment. The total length of your child's participation in the study will depend on the study plan and will be fully explained before you make any decisions.
Riesgos y beneficios potenciales
Locations (78)
- Instituto CAICI SRLCódigo postal verificadoRosario, Argentina· Activo, no reclutando
- Centro de Investigaciones Médicas TucumanNo verificadoSAN M. de Tucuman, Argentina· Activo, no reclutando
- Royal Children's HospitalCódigo postal verificadoMelbourne, Australia· Aún no reclutando
- Perth Children's HospitalCódigo postal verificadoPerth, Australia· Aún no reclutando
- The Children's Hospital at WestmeadCódigo postal verificadoWestmead, Australia· Activo, no reclutando
- Landeskrankenhaus BregenzCódigo postal verificadoBregenz, Austria· Completado
- Cliniques universitaires Saint-LucCódigo postal verificadoBruselas, Bélgica· Completado
- UZ GentCódigo postal verificadoGante, Bélgica· Reclutamiento
- UZ LeuvenCódigo postal verificadoLovaina, Bélgica· Reclutamiento
- Faculdade de Medicina da UNESPCódigo postal verificadoBotucatu, Brazil· Reclutamiento
- Universidade Federal de Sao PauloCódigo postal verificadoSão Paulo, Brasil· Reclutamiento
- Instituto da Crianca do Hospital das Clinicas da FMUSPCódigo postal verificadoSão Paulo, Brasil· Reclutamiento
Preguntas comunes
What is Juvenile Idiopathic Arthritis (JIA)?
JIA is a type of arthritis that affects children, causing joint pain, swelling, and stiffness.
What is baricitinib?
Baricitinib is a medicine being studied to see if it can help treat JIA.
¿Quién puede unirse a este estudio?
Children aged 1 to 17 who have already been in a previous baricitinib JIA study and tolerated the medicine well.
¿Es seguro este estudio?
All medicines have potential side effects. The study team will monitor your child closely, and any risks will be explained in full.
Can I stop my child's participation at any time?
Yes, you can withdraw your child from the study at any time without affecting their medical care.
Cómo obtener más información
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.