A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
This study is investigating a new medication, baricitinib, for children and teenagers between 1 and 17 years old who have systemic juvenile idiopathic arthritis (sJIA). This is a condition where young people get sore joints and other symptoms affecting their whole body. The main goal of this study is to find out if baricitinib is both safe to use and effective in helping to improve sJIA. Participants will either receive baricitinib or, in some cases, an existing medication called tocilizumab. Doctors will carefully monitor how participants respond to the treatment and check for any side effects. This research is important because it could lead to new ways to help young people manage their sJIA.
במבט חטוף
על מה המחקר הזה?
This study is all about helping children and young people who have a condition called systemic juvenile idiopathic arthritis, or sJIA for short. This is a type of arthritis that starts in childhood and can cause pain, swelling in joints, and also affect other parts of the body, leading to symptoms like fever and rashes.
The main purpose of this study is to test a new medicine called baricitinib. Researchers want to understand if this medicine is safe for young people with sJIA and if it can effectively reduce their symptoms and improve their overall health. They are comparing it with an existing treatment called tocilizumab in some cases, or just giving baricitinib to other participants.
This kind of research is really important because it helps doctors find better ways to treat conditions like sJIA. By taking part, families are helping to gather valuable information that could lead to new and improved treatments for many other young people living with this condition in the future.
נקודות עיקריות
- The study is for children and teens (1-17 years old) with sJIA.
- It tests a new medicine called baricitinib for safety and effectiveness.
- Some participants will compare baricitinib to an existing treatment.
- Regular clinic visits and check-ups will be needed.
- ההשתתפות היא בהתנדבות, ואתה יכול לפרוש בכל עת.
מי עשוי להיות זכאי?
To join this study, children and young people must be between 1 and 17 years old and have a clear diagnosis of systemic juvenile idiopathic arthritis (sJIA). They need to have at least two joints that are currently swollen or painful.
There are also some reasons why someone might not be able to join. For example, if they have other specific types of arthritis, a history of certain serious infections, or other autoimmune conditions not related to sJIA, they wouldn't be able to take part. Also, if they have certain conditions like active tuberculosis or recent problems with a serious immune system reaction called Macrophage Activation Syndrome, they won't be eligible.
The study team will carefully check each potential participant's medical history to make sure the study is a good fit for them and that it's safe for them to take part.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Is your child aged between 1 and 17 years old?
- Does your child have a diagnosis of systemic juvenile idiopathic arthritis (sJIA)?
- Does your child currently have at least two joints that are swollen or painful?
- Has your child not had certain serious infections or specific other autoimmune conditions lately?
מה כרוך בהשתתפות?
If you decide to take part in this study, your child will either receive the study medicine, baricitinib, or in some cases, an existing treatment called tocilizumab. The study is divided into two groups, and the doctors will choose which group is best for your child based on their medical history. You and your child will have regular visits to the clinic so that doctors can check their progress and how they are responding to the medication. This will involve physical examinations, blood tests, and discussions about any symptoms or side effects.
These visits are important for the doctors to make sure the medicine is working and that your child is safe. The full duration of the study will be explained in detail by the study team, and they will tell you exactly what to expect at each appointment, including how long each visit might take and what procedures are involved.
סיכונים ותועלות פוטנציאליים
Locations (55)
- Instituto CAICI SRLמיקוד מאומתרוסאריו, ארגנטינה
- Centro Medico Privado de Reumatologiaלא מאומתSAN M. de Tucuman, Argentina
- UZ Gentמיקוד מאומתגנט, בלגיה
- Faculdade de Medicina da UNESPמיקוד מאומתBotucatu, Brazil
- Hospital de Clinicas de Porto Alegreמיקוד מאומתפורטו אלגרה, ברזיל
- IPITECמיקוד מאומתSão Paulo, Brazil
- Universidade Federal de Sao Pauloמיקוד מאומתSão Paulo, Brazil
- Instituto da Crianca do Hospital das Clinicas da FMUSPמיקוד מאומתSão Paulo, Brazil
- Detska nemocnice FN Brnoמיקוד מאומתברנו, צ'כיה
- Vseobecna fakultni nemocnice v Prazeמיקוד מאומתפראג, צ'כיה
- Hospices Civils de Lyon - Hôpital Femme Mère Enfantמיקוד מאומתברון, צרפת
- Hôpitaux Universitaires Paris Sud - Hôpital Bicêtreמיקוד מאומתLe Kremlin-Bicêtre, France
שאלות נפוצות
What is systemic juvenile idiopathic arthritis (sJIA)?
It's a type of arthritis in children that causes joint pain and swelling, along with other symptoms like fevers and rashes throughout the body.
What is baricitinib?
Baricitinib is a new medication being tested to see if it can help reduce the symptoms of sJIA in children and teenagers.
Will my child definitely get the new medicine?
Some participants will receive baricitinib, while others might receive an existing treatment called tocilizumab, depending on which group they are assigned to.
How long will my child be in the study?
The full length of the study will be explained to you by the research team if you are eligible to take part.
האם אני יכול לעזוב את המחקר בכל עת?
Yes, you can withdraw your child from the study at any point, and it won't affect their regular medical care.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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