A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
This study is for children and teenagers aged 5 to 17 who have a medical condition called juvenile psoriatic arthritis (jPsA). This condition causes joint pain, swelling, and stiffness because the body's immune system mistakenly attacks healthy tissues. The study wants to find out how safe and effective a new medicine, risankizumab, is in treating jPsA, comparing it to an existing medicine, adalimumab. Both medicines are given as injections under the skin. Participants will be split into two groups, each receiving one of the medicines. The study will monitor changes in their jPsA symptoms and check for any side effects over a long period, potentially several years. Taking part involves regular hospital or clinic visits for check-ups and tests.
At a glance
What is this study about?
This study is looking into a new medicine called risankizumab for children and teenagers who have juvenile psoriatic arthritis (jPsA). jPsA is a type of arthritis that starts before someone turns 16. It happens when the body's defence system, called the immune system, starts attacking healthy parts of the body, leading to joint pain, swelling, and stiffness. We sometimes call this an 'autoimmune' condition. Currently, another medicine called adalimumab is approved to treat jPsA, and this study aims to see how risankizumab compares.
The main goal of this research is to understand how safe risankizumab is for young people with jPsA and how well it helps to improve their symptoms. The study will also look at how the medicine moves through the body. By comparing it to an existing treatment, researchers hope to see if risankizumab could be another helpful option for children and teenagers living with jPsA.
Finding new and effective treatments is really important for young people with jPsA to help manage their symptoms, improve their quality of life, and reduce the long-term impact of the condition. This study is a 'Phase 3' trial, which means the medicine has already gone through earlier safety tests and is now being tested in a larger group of people to confirm its safety and effectiveness.
Key takeaways
- A study for children/teens (5-17) with juvenile psoriatic arthritis (jPsA).
- Compares two injected medicines: new risankizumab vs. existing adalimumab.
- Aims to check safety and how well medicines improve jPsA symptoms.
- Participation involves regular clinic visits, blood tests, and questionnaires.
- Could be a long study, potentially over two years for some participants.
Who may be eligible?
To be considered for this study, children and teenagers generally need to be between 5 and 17 years old and have a confirmed diagnosis of juvenile psoriatic arthritis (jPsA) for at least three months. Importantly, their jPsA must currently be 'active', meaning they have swelling, pain, or tenderness in at least three of their joints.
Also, a key requirement is that a previous standard medicine for jPsA, such as methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine, hasn't worked well enough for them, or they couldn't tolerate it. This helps ensure the study is looking at new options for those who might need them.
However, some conditions would mean someone couldn't join. For example, if they have other autoimmune conditions (like lupus or other types of juvenile arthritis), or if they haven't responded well to certain groups of medicines in the past, they might not be able to participate.
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 between 5 and 17 years old?
- Have you been diagnosed with juvenile psoriatic arthritis (jPsA) for at least 3 months?
- Do you currently have active jPsA with at least three painful or swollen joints?
- Has a previous jPsA medicine (like methotrexate) not worked well for you or caused problems?
- Do you have any other types of autoimmune or rheumatic diseases?
- Have you previously tried and not responded to 'anti-TNF' or 'IL-23 inhibitor' medicines?
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of two groups by chance, like flipping a coin. One group will receive risankizumab, and the other will receive adalimumab. There's a 1 in 4 chance you'd receive adalimumab. Both medicines are given as injections under the skin, with the dose adjusted based on body weight.
Initially, for 24 weeks, you'll receive your assigned treatment. If your jPsA improves during this period, you could continue on the same treatment for a much longer time – potentially another 100 weeks. If your jPsA gets worse during this longer period, you would stop taking the study medicine.
Taking part involves regular visits to a hospital or clinic. These visits will include check-ups by doctors, blood tests, and discussions about any side effects you might be experiencing. You'll also be asked to fill in questionnaires about how you're feeling and how your jPsA is affecting you. After your last dose of the study medicine, you'll be followed closely for safety for a period of either 70 days (if you received adalimumab) or 140 days (if you received risankizumab). This is to make sure any late side effects are noted. Because of all these checks and visits, taking part might mean more appointments than your usual care.
Potential risks and benefits
Locations (32)
- Arkansas Children's Hospital /ID# 258776Verified postcodeLittle Rock, United States· Recruiting
- Childrens National Medical Center /ID# 259284Verified postcodeWashington D.C., United States· Recruiting
- Joe Dimaggio Children's Hospital Hollywood /ID# 260634Verified postcodeHollywood, United States· Recruiting
- Indiana University Health Riley Hospital for Children /ID# 259067Verified postcodeIndianapolis, United States· Recruiting
- M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111Verified postcodeMinneapolis, United States· Recruiting
- Columbia University Medical Center /ID# 262587Verified postcodeNew York, United States· Recruiting
- Boston Childrens Health Physicians /ID# 258061Verified postcodeValhalla, United States· Recruiting
- University of North Carolina - Children's Hospital /ID# 259286Verified postcodeChapel Hill, United States· Recruiting
- MetroHealth Medical Center /ID# 262377Verified postcodeCleveland, United States· Recruiting
- Child Neurology Consultants of Austin /ID# 260562Verified postcodeAustin, United States· Recruiting
- Monash Health - Monash Medical Centre /ID# 260255Verified postcodeClayton, Australia· Recruiting
- Alberta Children's Hospital /ID# 257880Verified postcodeCalgary, Canada· Recruiting
Common questions
What is juvenile psoriatic arthritis (jPsA)?
It's a type of arthritis in young people where the body's immune system attacks healthy joints, causing pain, swelling, and stiffness.
What medicines are being tested?
The study is testing a new medicine called risankizumab, comparing it to an existing medicine called adalimumab. Both are given as injections.
How old do I need to be to join?
Participants need to be between 5 and 17 years old.
How long will the study last?
Initially 24 weeks, but if your jPsA improves, you could continue on the study medicine for up to another 100 weeks, followed by a safety check-up period.
Will I have more hospital visits than usual?
Yes, taking part typically involves more regular hospital or clinic visits than your standard care for check-ups and tests.
How to find out more
ABBVIE CALL CENTER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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