A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)
This research study is for children and young people who have a condition called juvenile psoriatic arthritis. This is a type of arthritis that can cause painful joints and skin rashes. The study is comparing two existing medicines, called Stelara (ustekinumab) and Guselkumab, to see how well they work and if they are safe. We want to understand how these medicines act inside the body and how they help improve symptoms like joint pain and skin problems. The aim is to find out if these treatments can offer a good option for young people living with this condition.
At a glance
What is this study about?
This study is about a type of arthritis that affects children and young people, known as juvenile psoriatic arthritis. This condition can cause joints to become swollen and painful, and it can also cause skin rashes similar to psoriasis.
The research is looking at two medicines that are already used for similar conditions in adults: Stelara (ustekinumab) and Guselkumab. We want to find out how effective these medicines are at reducing the symptoms of juvenile psoriatic arthritis in young people. This includes checking how much they help with joint pain and swelling, as well as improving any skin problems.
We will also be carefully studying how the body handles these medicines, how safe they are to use, and if the body develops any reactions to them. By doing this, we hope to learn if Stelara and Guselkumab could be good treatment options to help young people with juvenile psoriatic arthritis feel better and live more comfortably.
Key takeaways
- This study is for children and young people with juvenile psoriatic arthritis.
- It's testing two medicines, Stelara and Guselkumab, to see how well they work and if they are safe.
- Participation involves regular clinic visits for injections, check-ups, and blood tests.
- The study aims to understand how these medicines affect joint pain and skin problems.
- You can stop taking part at any time without affecting your normal care.
Who may be eligible?
Children and young people of any age who have an active form of juvenile psoriatic arthritis might be able to take part in this study. Both boys and girls can join.
The study team will need to check your medical history to make sure this study is right for you and that taking part would be safe. They will look at things like how severe your arthritis is and if you have any other health conditions.
It's important to have a chat with your doctor or the study team to find out if you meet all the specific requirements to join.
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 I have juvenile psoriatic arthritis?
- Is my arthritis currently active (causing symptoms)?
- Am I willing to have injections?
- Can I attend regular clinic appointments for about a year?
What does participation involve?
If you decide to take part, you would receive either Stelara or Guselkumab as an injection under the skin. You would have regular visits to the clinic for check-ups, which would involve blood tests to see how the medicine is working and to monitor your general health. Doctors and nurses would also assess your joints and skin to see if your symptoms are improving.
These visits and assessments would happen at different times over the course of the study, which would last for about a year. The total duration of your involvement could be around 52 weeks or longer, depending on how you respond to the treatment and what the study doctors recommend. You'll be closely monitored throughout.
Potential risks and benefits
Locations (7)
- —UnverifiedFrance
- —UnverifiedPoland
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedDenmark
- —UnverifiedItaly
Common questions
What is juvenile psoriatic arthritis?
It's a type of arthritis in young people that causes joint pain and swelling, and can also lead to skin rashes like psoriasis.
What are Stelara and Guselkumab?
They are medicines given by injection that are being studied to see if they can help improve symptoms of juvenile psoriatic arthritis.
How will I receive the medicine?
The medicines will be given as an injection under the skin.
How long will the study last?
Your involvement in the study could last for about a year.
Can I stop being in the study if I want to?
Yes, you can choose to leave the study at any time, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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