I4V-MC-JAHU: Open-Label, Randomized Study with a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children from 1 to Less Than 18 Years of Age with Systemic Juvenile Idiopathic Arthritis
Systemic juvenile idiopathic arthritis (sJIA) is a rare condition that causes painful, swollen joints, fevers, and rashes in children and teenagers. This clinical trial is studying a medicine called baricitinib to see if it can help control these symptoms safely. Baricitinib works by calming down an overactive immune system. In this study, young people will be placed into groups to receive either baricitinib or another medicine called tocilizumab, which is already used to treat sJIA. Some matching dummy treatments (placebos) may also be used to ensure the study results are fair and reliable. Doctors will measure how well symptoms improve after 12 weeks of treatment. They will also look closely at how the body handles the medicine and check for any side effects. The goal is to see if baricitinib could become a helpful new treatment option for children living with sJIA.
En un coup d'œil
De quoi parle cette étude ?
Systemic juvenile idiopathic arthritis, often shortened to sJIA, is an inflammatory condition that affects children and teenagers. In sJIA, the body's immune system mistakenly attacks healthy tissues. Alongside swollen and painful joints, it can cause high fevers, skin rashes, and severe tiredness. Finding effective treatments that keep symptoms under control is very important to help young people stay active and grow normally.
This phase 3 trial is looking at a medicine called baricitinib. Baricitinib belongs to a family of medicines called JAK inhibitors, which work by blocking specific chemical messages that cause inflammation. Researchers want to find out how well baricitinib works and how safe it is compared to tocilizumab, an effective medicine doctors already use for sJIA. They will also measure how the body absorbs and processes baricitinib in children of different ages.
While good treatments exist, not every child responds well to current options, and some medicines must be given by injections or hospital drips. Baricitinib can be taken by mouth as a tablet or liquid, which may be much easier and more comfortable for children and their families. This study aims to provide the clear evidence needed to determine whether baricitinib is a reliable new choice for treating sJIA.
Points clés
- Tests a medicine called baricitinib for children aged 1 to 17 with sJIA.
- Compares baricitinib against an existing standard treatment called tocilizumab.
- Looks at how safely and effectively baricitinib calms joint pain, fever, and inflammation.
- Offers an oral alternative (tablets or liquid) to injected arthritis treatments.
- Participation is voluntary and includes close, ongoing health checks by specialists.
Qui peut être éligible ?
This trial is open to children and young people aged between 1 and 17 years old who have been diagnosed with systemic juvenile idiopathic arthritis (sJIA). Both boys and girls can take part.
To be eligible, participants usually need to have active signs of arthritis or ongoing inflammation that has not settled down with their current care. A doctor will review your child's medical history to confirm that their diagnosis fits the trial requirements.
Children may not be able to join if they have an active severe infection, certain other long-term health problems, or a known allergy to the study medicines. The trial team will run health checks and blood tests before anyone starts treatment to ensure it is completely safe for them to take part.
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Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Aged between 1 and 17 years old.
- Diagnosed with systemic juvenile idiopathic arthritis (sJIA).
- Currently experiencing active joint swelling or arthritis symptoms.
- Willing and able to attend hospital visits for regular monitoring and blood tests.
- Free from any active, severe infections.
En quoi consiste la participation ?
Taking part in the study involves regular visits to a specialist hospital clinic. At the start, a computer will assign your child by chance (randomly) to receive either baricitinib or tocilizumab. Baricitinib is taken by mouth as a tablet or liquid suspension, whereas tocilizumab is given as an injection or drip. Matching dummy treatments (placebos) may be used alongside to make sure the comparison is fair.
Your child will attend regular appointments so doctors can monitor their progress. These visits include physical examinations, joint checks, blood tests, and questions about how your child is feeling day to day. A key assessment happens at week 12 to measure how well the treatment is working. The study team will provide a clear calendar of all visits and will support your family throughout the entire process.
Risques et avantages potentiels
Emplacements (7)
- —Non vérifiéBelgique
- —Non vérifiéPologne
- —Non vérifiéTchéquie
- —Non vérifiéFrance
- —Non vérifiéAutriche
- —Non vérifiéItalie
- —Non vérifiéEspagne
Questions fréquentes
What age does my child need to be to take part?
The study is for children and young people aged between 1 and 17 years old who have systemic juvenile idiopathic arthritis.
How is the study medicine taken?
Baricitinib is taken by mouth as a tablet or a liquid medicine. The comparison medicine, tocilizumab, is given as an injection or via an intravenous drip.
Will my child definitely get the new medicine?
Not necessarily. A computer will randomly decide whether your child receives baricitinib or the standard medicine, tocilizumab.
Do we have to pay for anything?
No, all study medicines, clinic visits, and tests are provided free of charge, and help with travel expenses is usually available.
Can we change our minds after starting?
Yes, you can leave the study at any point. Your decision will not affect the standard of care your child receives from their regular doctors.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
Discussion
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