A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
This study is investigating a new medication called Upadacitinib for children and young people aged 2 to 17 years old who have a specific type of arthritis called polyarticular course Juvenile Idiopathic Arthritis (JIA). The main goals are to understand how the medicine moves through the body, to see if it's safe, and to check if participants can take it without too many problems. The study has a few parts, starting with a short period where different groups receive the medicine. If it helps and there are no serious side effects, participants might be able to continue taking the medicine long-term to keep checking its safety. This research aims to find better ways to treat JIA in young people.
At a glance
What is this study about?
This research study is looking into a new medication called Upadacitinib for children and young people who have a condition called polyarticular course Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that starts before the age of 16, and 'polyarticular course' means it affects five or more joints. The main purpose of this study is to learn more about how Upadacitinib works in children's bodies, whether it's safe to use, and if it can be tolerated well by young patients.
The study is divided into several parts. Initially, different groups of participants will take the medicine to help us understand how their bodies handle it. If a participant benefits from the medication and doesn't experience any serious side effects, they might be able to continue taking it in a longer-term part of the study. This longer-term part helps us keep a close eye on the medicine's safety and how well it is tolerated over time. There's also an extra part focused solely on looking at the long-term safety.
The overall aim of this study is to gather important information about Upadacitinib. By understanding how it works and its safety in children with JIA, researchers hope to see if it could become a helpful new treatment option for managing this condition. This is a very early-stage study (Phase 1), meaning it's one of the first times this medicine is being studied in children with JIA.
Key takeaways
- This study is testing a new medicine called Upadacitinib for children with JIA.
- It's mainly looking at how the medicine works in the body and if it's safe.
- Children aged 2 to 17 with polyarticular course JIA are eligible.
- Regular check-ups and monitoring will be part of the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, children and young people need to be between 2 and 17 years old and weigh at least 10 kg (about 22 pounds). They must have a diagnosis of polyarticular course JIA, which means their arthritis affects five or more joints. At the time of checking, they should have five or more joints that are actively swollen or painful with limited movement.
If they are currently taking certain other medications for their JIA, there are specific requirements. For example, if they're on methotrexate, they need to have been on a stable dose for at least 12 weeks. If taking steroid tablets, the dose must also be stable and not too high for at least a week before starting the study.
However, some children won't be able to join. This includes those with other specific types of arthritis like enthesitis-related arthritis or juvenile psoriatic arthritis. Also, if they've ever taken a medicine called a 'JAK inhibitor' before, they won't be able to participate in this study.
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 your child aged between 2 and 17 years old?
- Does your child weigh at least 10 kg (about 22 pounds)?
- Does your child have polyarticular course Juvenile Idiopathic Arthritis?
- Does your child currently have 5 or more active (swollen or painful) joints?
- Has your child never taken a medicine called a 'JAK inhibitor' before?
What does participation involve?
If you or your child decides to take part in this study, they will receive the study medication, Upadacitinib. The study has different parts. Initially, participants will be part of a group taking the medication. During this time, they will have regular visits to the clinic where doctors and nurses will do check-ups, take blood samples, and ask about any side effects. This is to understand how the medicine is working and to monitor their health carefully. If a participant is doing well on the medication and not experiencing serious side effects, they might have the opportunity to continue taking it in a longer-term part of the study. This long-term phase will involve ongoing check-ups to keep monitoring the safety and how well the treatment is tolerated over an extended period. The total duration of participation will depend on which parts of the study a participant is involved in.
Potential risks and benefits
Locations (35)
- Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162Verified postcodeChicago, United States
- Duplicate_University of Louisville /ID# 202896Verified postcodeLouisville, United States
- Boston Children's Hospital /ID# 202993Verified postcodeBoston, United States
- Cincinnati Childrens Hospital Medical Center /ID# 209697Verified postcodeCincinnati, United States
- Randall Children's Hospital /ID# 213609Verified postcodePortland, United States
- Children's Hospital of Philadelphia /ID# 209617Verified postcodePhiladelphia, United States
- Children's Hospital of Pittsburgh of UPMC /ID# 202994Verified postcodePittsburgh, United States
- Seattle Children's Hospital /ID# 203003Verified postcodeSeattle, United States
- Alberta Children's Hospital /ID# 251738Verified postcodeCalgary, Canada
- British Columbia Children and Women's Hospital and Health Centre /ID# 251736Verified postcodeVancouver, Canada
- Duplicate_McGill University Health Centre /ID# 251252Verified postcodeMontreal, Canada
- Asklepios Klinik Sankt Augustin /ID# 203264Verified postcodeSankt Augustin, Germany
Common questions
What is Upadacitinib?
Upadacitinib is a new medicine being tested to see if it can help treat Juvenile Idiopathic Arthritis (JIA) in children.
What is polyarticular course Juvenile Idiopathic Arthritis (JIA)?
It's a type of arthritis that starts in children and affects five or more joints in their body.
Will my child definitely get the new medicine?
Yes, in this study, all participants will receive the study medicine, Upadacitinib.
How long will my child be in the study?
The study has different parts; how long your child participates depends on which parts they join, especially if they continue into the longer-term follow-up.
Can we stop participating if we change our minds?
Yes, you can choose to withdraw your child from the study at any time, for any reason, without impacting their ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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