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.
At a glance
What is this study about?
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.
Key takeaways
- 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.
Who may be eligible?
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.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- 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?
What does participation involve?
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.
Potential risks and benefits
Locations (56)
- Phoenix Children's Hospital /ID# 253403Verified postcodePhoenix, United States· Recruiting
- Arkansas Children'S Hospital /ID# 278405Verified postcodeLittle Rock, United States· Not yet recruiting
- Childrens National Medical Center /ID# 253344Verified postcodeWashington D.C., United States· Recruiting
- Joe Dimaggio Children's Hospital Hollywood /ID# 278992Verified postcodeHollywood, United States· Not yet recruiting
- New York Medical College /ID# 253437Verified postcodeValhalla, United States· Recruiting
- Levine Children's Hospital /ID# 253491Verified postcodeCharlotte, United States· Completed
- Cincinnati Childrens Hospital Medical Center /ID# 251827Verified postcodeCincinnati, United States· Recruiting
- Nationwide Children'S Hospital /ID# 278994Verified postcodeColumbus, United States· Not yet recruiting
- Randall Children's Hospital /ID# 251829Verified postcodePortland, United States· Recruiting
- UT Health Houston /ID# 278665Verified postcodeHouston, United States· Not yet recruiting
- Children'S Wisconsin /ID# 278652Verified postcodeMilwaukee, United States· Not yet recruiting
- Instituto CAICI S.R.L /ID# 251448Verified postcodeRosario, Argentina· Recruiting
Common questions
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.
How long will the study last?
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.
How to find out more
ABBVIE CALL CENTER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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