A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
This research study is looking at a new medication called risankizumab for adults who have active psoriatic arthritis. This is a type of arthritis linked to psoriasis that can cause pain and swelling in joints. The study is particularly interested in people who haven't found relief with other biologic treatments or traditional medications. Its main goals are to check how safe risankizumab is and how well it works to improve symptoms. Participants will receive either risankizumab or a dummy treatment (placebo) initially, with everyone eventually receiving risankizumab. The study lasts for a long time, helping researchers understand its effects over several years.
At a glance
What is this study about?
Many people living with psoriatic arthritis experience ongoing joint pain, swelling, and stiffness, even after trying different treatments. This can significantly impact daily life. Researchers are always looking for new and more effective ways to help manage this condition.
This particular study is focusing on a medicine called risankizumab. It's designed to see if risankizumab can safely and effectively reduce the symptoms of moderate to severe psoriatic arthritis. This is important because it could offer another treatment option for people who haven't had good results with existing medications, including those called biologics.
The study is in 'Phase 3,' which means it's a large and important step in testing new medicines. It compares risankizumab directly with a 'placebo' (a dummy treatment with no active medicine) to clearly assess its benefits. The information gathered will help doctors and patients make informed decisions about future treatment options for psoriatic arthritis.
Key takeaways
- This study evaluates a potential new drug, risankizumab, for psoriatic arthritis.
- It's for adults with active psoriatic arthritis, especially those who haven't improved with other treatments.
- Participants will receive either risankizumab or a dummy treatment initially.
- The study lasts a long time (up to 6.5 years) to understand long-term effects.
- Regular clinic visits and careful monitoring are part of the study.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 or older, with a clear diagnosis of psoriatic arthritis that has been active for at least six months. Your arthritis should still be causing significant symptoms, specifically at least five tender and five swollen joints.
You also need to have active skin psoriasis, with at least one patch that is 2cm or larger, or have psoriasis affecting your nails. Crucially, you must have tried and either not responded well to, or had trouble tolerating, other treatments for your arthritis, such as biologic therapies or traditional anti-rheumatic drugs.
There are also some reasons why you might not be able to join. For example, if you've previously had a bad reaction to risankizumab, or if, for any other health reason, the study doctor believes it wouldn't be safe or suitable for you.
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 an adult aged 18 or older?
- Do you have a diagnosis of psoriatic arthritis that's been active for at least 6 months?
- Do you currently have at least 5 tender and 5 swollen joints?
- Do you have active skin psoriasis (patch ≥ 2cm or nail changes)?
- Have other psoriatic arthritis treatments (like biologics or DMARDs) not worked well for you or caused problems?
- Have you ever had a serious allergic reaction to risankizumab?
What does participation involve?
If you join this study, it will involve several stages over a long period, potentially up to about six and a half years. Firstly, there's a screening period of about five weeks to check if you're suitable. Once accepted, for the first 24 weeks, you'll be randomly assigned to receive either risankizumab or a dummy treatment (placebo). You won't know which one you're getting, and neither will your study doctor.
After 24 weeks, everyone will receive risankizumab. For some time, you'll still be 'blinded' to what you originally received, but eventually, everyone will receive the active study drug. You'll receive the medicine as injections every 12 weeks. Throughout the study, you'll have regular visits to the clinic for assessments to monitor your arthritis, check for any side effects, and see how you're responding to treatment. There will also be a follow-up phone call about 20 weeks after your last dose of medication.
Potential risks and benefits
Locations (138)
- Pinnacle Research Group /ID# 167953Verified postcodeAnniston, United States
- St. Jude Heritage /ID# 166842Verified postcodeFullerton, United States
- Newport Huntington Medica /ID# 207423Verified postcodeHuntington Beach, United States
- Arthritis & Osteo Medical Ctr /ID# 166541Verified postcodeLa Palma, United States
- East Bay Rheumatology Medical /ID# 166845Verified postcodeSan Leandro, United States
- Inland Rheum Clin Trials Inc. /ID# 166621Verified postcodeUpland, United States
- Denver Arthritis Clinic /ID# 166442Verified postcodeDenver, United States
- New England Research Associates, LLC /ID# 166525Verified postcodeBridgeport, United States
- Yale University /ID# 166330Verified postcodeNew Haven, United States
- Arthritis & Rheumatic Disease Specialties /ID# 212582Verified postcodeAventura, United States
- SIMED Health, LLC /ID# 207457Verified postcodeGainesville, United States
- Sweet Hope Research Specialty Inc /ID# 168163Verified postcodeHialeah, United States
Common questions
What is risankizumab?
Risankizumab is a new medicine being tested to help reduce the symptoms of psoriatic arthritis.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps researchers see if the actual medicine really works.
How long will the study last if I join?
The study could last for up to 336 weeks, which is about six and a half years, including a follow-up call after your last dose.
Will I know if I'm getting the real medicine or the placebo?
For the first 24 weeks, neither you nor your study doctor will know. After that, everyone will eventually receive risankizumab, though you'll remain unaware of your initial group.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without having to give a reason, and it won't affect your regular 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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