Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.
This study is investigating new ways to treat a serious form of arthritis that affects children, known as Systemic Juvenile Idiopathic Arthritis (sJIA). This condition is a long-lasting illness that not only causes painful, swollen joints but can also affect other parts of the body like the liver, lungs, and heart. Researchers want to find out how safe and effective a new medicine called upadacitinib is for children and teenagers aged 1 to 17 with sJIA. They are comparing it to an existing treatment, tocilizumab. The study will look at how well these treatments reduce the illness's activity and if they cause any unwanted side effects. Understanding these new options is important for improving the lives of children living with this challenging condition.
במבט חטוף
על מה המחקר הזה?
This study is looking into better ways to treat a specific type of arthritis that affects children, called Systemic Juvenile Idiopathic Arthritis (sJIA). Arthritis generally means painful, swollen joints. In children, it's called Juvenile Idiopathic Arthritis (JIA), and 'idiopathic' simply means we don't know exactly why it starts. sJIA is a rarer and more serious form because it doesn't just affect the joints; it can also impact other organs in the body, such as the liver, lungs, or heart. Currently, sJIA can be difficult to diagnose and manage, and it can be a lifelong condition.
The main goal of this research is to test a new medicine called upadacitinib. We want to understand how safe it is and how well it works to reduce the symptoms of sJIA in young people from 1 to under 18 years old. To do this, we'll be comparing upadacitinib with another treatment that is already used for sJIA, called tocilizumab. The study will check if these treatments can make the disease less active and if there are any side effects.
This is important because finding more effective and safer treatments for sJIA could significantly improve the health and quality of life for children and teenagers living with this challenging condition. It could help them have less pain, more movement, and generally feel better, helping them lead more active lives.
נקודות עיקריות
- This study is for children and teenagers with a severe type of arthritis called sJIA.
- It's testing a new medicine, upadacitinib, against an existing one, tocilizumab.
- The study aims to check how safe and effective these treatments are.
- Participants will have regular check-ups for about one year.
- It could offer a new treatment option for sJIA.
- You can withdraw from the study at any time without penalty.
מי עשוי להיות זכאי?
To join this study, children and teenagers must have Systemic Juvenile Idiopathic Arthritis (sJIA) that started before they were 16 years old and has been active for at least six weeks. They must weigh at least 10 kg and be between 1 and 17 years old. The sJIA needs to still be active despite previous treatments like anti-inflammatory medicines or steroids.
There are two groups in the study. For one group, children must not have received a specific type of medicine called an IL-6 inhibitor before. For the other group, children must have previously tried an IL-6 inhibitor but it didn't work well enough or they couldn't tolerate it.
However, this study isn't for everyone. Children cannot join if they have other types of arthritis or other serious auto-immune conditions. They also can't take part if they have another uncontrolled serious illness or a specific severe immune condition called macrophage activation syndrome in the month before the study starts. These rules help make sure the study includes the right participants for accurate results and their safety.
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 my child between 1 and 17 years old?
- Does my child have Systemic Juvenile Idiopathic Arthritis (sJIA)?
- Has my child tried previous sJIA treatments that didn't fully work?
- Does my child weigh at least 10 kilograms (about 22 pounds)?
- Does my child have active sJIA symptoms right now?
- Has my child not had an IL-6 inhibitor before, or did it not work well for them?
מה כרוך בהשתתפות?
If you decide to take part, your child will either receive upadacitinib, which is given as a tablet or a liquid by mouth, or tocilizumab, which is given as an injection under the skin or through a drip into a vein. Your child will take this medicine once or twice a day, depending on the type. This treatment will continue for about 52 weeks (roughly one year).
During this year, your child will have regular check-ups at a hospital or clinic. These visits might be more frequent than their usual appointments. At these visits, doctors will perform medical assessments, blood tests, and check for any side effects. You and your child will also be asked to fill out questionnaires about how they are feeling and how the treatment is affecting them. After the treatment period, there will be one final follow-up visit or call about 30 days later to check on their health.
סיכונים ותועלות פוטנציאליים
מיקומים (45)
- Phoenix Children's Hospital /ID# 253403מיקוד מאומתפניקס, ארצות הברית· גיוס
- Childrens National Medical Center /ID# 253344מיקוד מאומתוושינגטון די.סי., ארצות הברית· גיוס
- Boston Childrens Health Physicians /ID# 253437מיקוד מאומתValhalla, United States· גיוס
- Levine Children's Hospital /ID# 253491מיקוד מאומתשארלוט, ארצות הברית· הושלם
- Cincinnati Childrens Hospital Medical Center /ID# 251827מיקוד מאומתסינסינטי, ארצות הברית· גיוס
- Randall Children's Hospital /ID# 251829מיקוד מאומתפורטלנד, ארצות הברית· גיוס
- Instituto CAICI S.R.L /ID# 251448מיקוד מאומתרוסאריו, ארגנטינה· גיוס
- Centro de Investigaciones Medicas Tucuman /ID# 251781מיקוד מאומתסן מיגל דה טוקומאן, ארגנטינה· גיוס
- Hospital de Niños de la Santisima Trinidad /ID# 252736מיקוד מאומתקורדובה, ארגנטינה· גיוס
- Monash Health - Monash Medical Centre - Clayton /ID# 251691מיקוד מאומתClayton, Australia· הושלם
- Royal Children's Hospital /ID# 251663מיקוד מאומתParkville, Australia· הושלם
- Landeskrankenhaus Bregenz /ID# 266317מיקוד מאומתBregenz, Austria· גיוס
שאלות נפוצות
What is Systemic Juvenile Idiopathic Arthritis (sJIA)?
It's a serious type of childhood arthritis that can affect joints as well as other body parts like the liver, lungs, and heart.
What is upadacitinib?
Upadacitinib is a new medicine being tested to see if it can help treat sJIA. It's given as a tablet or a liquid.
כמה זמן יימשך המחקר?
Your child will receive treatment for about one year, with a follow-up about a month after that.
Will my child know which treatment they are getting?
Some participants will know, as one group is directly comparing upadacitinib to tocilizumab, while another group only receives upadacitinib.
Can my child leave the study at any time?
Yes, you can choose to withdraw your child from the study at any point, and it won't affect their future medical treatment.
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