AuthorisedTherapeutic use (Phase IV)Interventional

Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis

This study is for children with a specific type of arthritis called systemic Juvenile Idiopathic Arthritis (sJIA), also known as Still's disease. Researchers want to find out the best way to use a medicine called anakinra (Kineret) to control the disease. They are looking at how many injections are needed for children to feel well and for their symptoms to completely go away. The study also explores if children can safely stop taking the medication and remain healthy. They will be checking how many children stay well after stopping and if the illness comes back. The study also tracks any side effects. The main goal is to find an effective and safe way to use this treatment.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

Start

13 Dec 2024

autoimmune disorders joint disorders synonym: Still's disease systemic JIA

What is this study about?

This study is about a condition called systemic Juvenile Idiopathic Arthritis, or sJIA for short. You might also hear it called Still's disease. It's a type of arthritis that affects children, causing joint pain and swelling, as well as symptoms like fever and rash. The researchers want to find the best way to use a medicine called anakinra, which goes by the brand name Kineret, to help children with sJIA. This medicine comes as an injection.

The main aim is to discover how many injections of anakinra a child needs, on average, to get their sJIA under control and keep it that way for the first year. 'Under control' means their symptoms have effectively disappeared. The study also wants to see if children can stop taking the medicine after a while and remain well without it, or if their symptoms come back. By understanding this, doctors hope to find the most effective and safest treatment plan for sJIA, potentially helping children to live without medication sooner.

Beyond simply counting injections, the study will also look at other important things. For example, it will check how many children stay well without any medication after one and two years. They'll also monitor if the disease flares up (comes back) after stopping the medicine and if any children need to switch to a different treatment. Finally, and very importantly, they'll be keeping a close eye on any side effects or problems that might happen during the first year of treatment. This information will help doctors recommend the best treatment plans for young people with sJIA in the future.

Key takeaways

This study helps doctors best use anakinra for childhood arthritis called sJIA.
It aims to find out how many injections are needed for symptoms to vanish.
Researchers want to know if children can stay well after stopping the medicine.
They will also track any side effects from the treatment.
Participation involves regular check-ups and follow-up for up to two years.

Who may be eligible?

To take part in this study, you or your child would need to have been diagnosed with systemic Juvenile Idiopathic Arthritis (sJIA). This study includes people of all ages who have this condition, and it's open to both boys and girls.

There aren't many strict rules about who can join this study from the information we have. The main thing is to have sJIA. If you or your child have other serious health problems, or are taking certain other medicines, you might not be able to join. These details would be discussed fully with your doctor and the study team.

The research team will carry out some checks to make sure the study is a good fit for you or your child, and that it's safe to take part. This process ensures that the study results are clear and helpful for others with sJIA.

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.

Do you or your child have systemic Juvenile Idiopathic Arthritis (sJIA)?
Have you discussed your condition and medicines with your doctor?
Are you able to attend regular appointments for check-ups?
Are you interested in helping doctors learn more about sJIA treatment?

Answer every question to see your result.

What does participation involve?

If you or your child decided to take part in this study, the main part of it involves using the medicine anakinra (Kineret) as injections. The study will track how many injections are given to get the disease symptoms under control and then keep them away. You would have regular appointments to see the study doctors and nurses, who will check on how the treatment is working and if there are any side effects. They will likely ask about symptoms, check joints, and potentially take blood samples.

Throughout the first year, they will carefully watch if the disease stays inactive or if it flares up. They will also assess if and when you or your child can safely reduce or stop the medication. Follow-up continues for up to two years to see if the disease remains under control without the medicine. The total duration of active participation and follow-up would be up to two years, with more frequent visits at the beginning.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. A possible benefit here is that doctors might find the best way to use anakinra to help children with sJIA get better and potentially stop medication sooner. This could lead to a better quality of life. However, as with any medicine, there are potential side effects from anakinra, which the doctors will explain in full detail. You would be closely monitored for these. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is systemic Juvenile Idiopathic Arthritis (sJIA)?

It's a type of arthritis in children causing joint pain and swelling, often with other symptoms like fever and rash. It's sometimes called Still's disease.

What is anakinra (Kineret)?

It's a medicine used to treat sJIA. It's given as an injection and helps to reduce inflammation in the body.

What does 'clinically inactive disease' mean?

It means the disease symptoms are completely gone, and medical tests show no signs of active disease.

Will my child have to stay on the medication forever if they join?

No, a key part of the study is to see if children can safely stop the medication and remain well.

What is a 'Phase IV' study?

This means the medicine is already approved for use, and this study is looking at the best ways to use it in real-world patients.