Active not recruitingPHASE3INTERVENTIONAL

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

This research study is for children and young people aged 5 to 17 who have a type of arthritis called juvenile psoriatic arthritis (jPsA). We're investigating two different medicines, ustekinumab and guselkumab, that might help manage the condition when other treatments haven't been enough. The study aims to understand how these medicines move through the body (pharmacokinetics), how effective they are at reducing symptoms, if they are safe to use, and how the body's immune system reacts to them. By carefully studying these new treatments, we hope to find better ways to help young people with jPsA feel better and live more comfortably. Your involvement could help improve future care for others.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

30 Aug 2022

Estimated completion

05 Dec 2026

Arthritis, Juvenile

What is this study about?

This study is a really important step in finding better treatments for children and young people who have juvenile psoriatic arthritis (jPsA). jPsA is a condition where the body's immune system mistakenly attacks its own joints, causing pain, swelling, and stiffness, and it can also cause skin problems, like psoriasis. When children and teenagers live with jPsA, it can make everyday activities difficult and impact their school life, hobbies, and overall wellbeing.

Current treatments do a good job for many, but some young people still struggle to get their condition under control. That's where this study comes in. We're testing two specific medicines, ustekinumab and guselkumab, to see if they can help those who haven't found enough relief from other treatments. These medicines work by targeting specific parts of the immune system that cause inflammation in jPsA.

The main goal is to understand how well these medicines work to reduce the symptoms of jPsA, how safe they are, and how the child's body processes them. By learning more about these treatments, we hope to improve the quality of life for young people with jPsA and offer more effective options in the future.

Key takeaways

Targets children and teens aged 5-17 with active juvenile psoriatic arthritis (jPsA).
Investigates two new medicines, ustekinumab and guselkumab, for safety and effectiveness.
Aims to find better treatment options for jPsA when standard therapies haven't fully helped.
Participation involves giving consent and attending regular clinic visits for monitoring.
Potential benefits include access to new treatments, but side effects are possible.
Participants can leave the study at any time without affecting their regular medical care.

Who may be eligible?

To join this study, young people must be between 5 and 17 years old and have been diagnosed with juvenile psoriatic arthritis (jPsA) for at least three months. It's important that their arthritis is currently active, meaning they have at least three joints that are swollen or painful and stiff, despite having tried other common treatments like non-biologic DMARDs or NSAIDs.

There are also some health conditions that would mean someone couldn't take part. This includes having a history of certain serious infections like tuberculosis, specific fungus infections, or hepatitis C. Also, if a child has a history of shingles in the last eight weeks, they would not be able to join. Your doctor will be able to check all of these points carefully to see if this study is right for you or your child.

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.

Are you/is your child aged between 5 and 17?
Has a doctor diagnosed you/your child with juvenile psoriatic arthritis (jPsA) for at least 3 months?
Is your/your child's arthritis currently active (painful/swollen joints) despite other treatments?
Do you/your child have all current vaccinations?
Do you/your child NOT have certain serious infections (like TB, hepatitis C, or recent shingles)?
Have you/your child NOT been diagnosed with enthesitis-related arthritis (a different type of arthritis)?

Answer every question to see your result.

What does participation involve?

The detailed plan for taking part in this study isn't fully described here, but generally, clinical trials involve regular visits to a clinic. During these visits, the study team would check your or your child's health, monitor the arthritis, and perhaps take blood samples or perform other assessments. You would be given either ustekinumab or guselkumab as part of the study. The total length of the study would involve an initial treatment period and then a follow-up period to see how the medicines continue to work and if there are any long-term effects. All details about visits, tests, and medication will be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new treatment that could help improve your or your child's juvenile psoriatic arthritis, potentially reducing pain and inflammation. However, like all medicines, ustekinumab and guselkumab can have side effects, which the study team will explain in detail. There's also no guarantee that the treatment will work for everyone. You or your child can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

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

Childrens Hospital Los Angeles
Verified postcode
Los Angeles, United States
UCLA
Verified postcode
Los Angeles, United States
Harvard Medical School - Boston Children's Hospital
Verified postcode
Boston, United States
Northwell Health
Verified postcode
New York, United States
Montefiore Medical Center
Verified postcode
The Bronx, United States
University of North Carolina
Verified postcode
Chapel Hill, United States
Cincinnati Children's Hospital Medical Center
Verified postcode
Cincinnati, United States
Legacy Emanuel Medical Center
Verified postcode
Portland, United States
University of Utah
Verified postcode
Salt Lake City, United States
STAT Research S A
Unverified
Ciudad Autonoma Buenos Aires, Argentina
Hospital de Ninos de Cordoba
Verified postcode
Córdoba, Argentina
Instituto Medico Platense
Verified postcode
La Plata, Argentina

Common questions

What is juvenile psoriatic arthritis (jPsA)?

jPsA is a type of arthritis that affects children and teenagers, causing joint pain, swelling, and stiffness. It can also cause skin problems like psoriasis.

Why is this study being done?

This study aims to find out if two new medicines, ustekinumab and guselkumab, are safe and effective in treating jPsA for young people when other treatments haven't been enough.

What are ustekinumab and guselkumab?

These are types of medicines called 'biologics' which work by targeting specific parts of the immune system that cause inflammation in arthritis.

Will I or my child stop current medication if we join?

Not necessarily. Some current medications, like certain arthritis drugs, can be continued at a stable dose during the study, but this will be carefully reviewed by the study team.

Is there a cost to participate?

Clinical trials generally cover the cost of study-related medicines and visits. Any expenses like travel might be reimbursed, but you should confirm this with the study team.