A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
This research is looking into a new medicine called risankizumab for adults with psoriatic arthritis that is still active and hasn't responded to previous treatments. Psoriatic arthritis causes joint pain and swelling, often alongside skin problems. The study aims to see if risankizumab is safe and helps to improve symptoms better than a dummy treatment (placebo). Participants will initially receive either risankizumab or placebo, with all participants eventually receiving risankizumab later in the study. The study will track symptoms and side effects over a long period to understand the medicine's full effects. It's a key step in finding new ways to manage psoriatic arthritis for people in the UK.
At a glance
Results
Results from this study
Posted February 2022Results have been published for this study.
What is this study about?
This study is designed to learn more about a new medication called risankizumab. It's specifically for adults in the UK who have psoriatic arthritis that's still causing problems, even after trying other common treatments. Psoriatic arthritis is a condition where your immune system mistakenly attacks your joints, leading to pain, swelling, and stiffness. It often occurs in people who also have psoriasis, a skin condition.
The main goal of this study is to compare risankizumab with a placebo (a dummy treatment that looks like the real medicine but contains no active ingredients). Researchers want to see if risankizumab can safely and effectively reduce the pain, swelling, and other symptoms of psoriatic arthritis. Finding new treatments is really important for people whose current medicines aren't working well.
This type of study, called a Phase 3 trial, is normally one of the last steps before a medicine might become widely available. This means the medicine has already been tested in earlier stages and shown some promise. By carefully comparing it to a placebo, doctors can get a clear picture of how well it works and if it has any important side effects.
Key takeaways
- This study is for adults with active psoriatic arthritis that hasn't responded to previous treatments.
- It compares a new medicine, risankizumab, with a placebo (dummy treatment).
- Participation involves regular clinic visits for over 6 years.
- Initially, you might receive risankizumab or placebo; eventually, everyone receives risankizumab.
- The aim is to find out if risankizumab is safe and effective for psoriatic arthritis.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, people need to be adults (18 or older) with a clear diagnosis of psoriatic arthritis. Their arthritis must be active, meaning they have a certain number of tender and swollen joints, and they should also have active psoriasis on their skin or nails.
It's important that those who join have already tried other common treatments for their arthritis, called DMARDs, and these haven't worked well for them or they couldn't tolerate them. Also, they need to show some specific signs of joint damage or inflammation in their blood tests.
However, some people won't be able to join. This includes if the doctors think the study isn't right for them for any reason, if they're allergic to risankizumab, or if they've already received a 'biologic' type of medication for their condition in the past. Your doctor will be able to check all of these points with 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 18 years old or older?
- Have you been diagnosed with psoriatic arthritis?
- Do you have active joint pain and swelling (your doctor can check this)?
- Do you have active psoriasis (on skin or nails)?
- Have other psoriatic arthritis medicines you've tried not worked well for you or caused problems?
- Have you never received a 'biologic' type of medicine before?
What does participation involve?
If you join this study, you'll first have a screening period of about 5 weeks to check if you're eligible. The study then has different parts that add up to a very long time – roughly 6 and a half years from start to finish! During this time, you'll have regular visits to your study doctor or clinic.
For the first 24 weeks, you'll be given either risankizumab or a placebo, but you and your doctor won't know which one this is (this is called 'double-blind'). After 24 weeks, everyone in the study will start receiving risankizumab. You'll continue to receive risankizumab every 12 weeks for a very long time, up to 316 weeks (over 6 years). Even though everyone receives the active medicine later, you will still be 'blinded' to whether you were in the original risankizumab or placebo group until the very end of the study.
During your visits, you'll have assessments to check your psoriatic arthritis symptoms, your general health, and to see how the medicine is affecting you. This will likely involve examinations, blood tests, and possibly other tests. There will also be a follow-up phone call about 20 weeks after your last dose of the study medicine.
Potential risks and benefits
Locations (256)
- Pinnacle Research Group /ID# 167955Verified postcodeAnniston, United States
- Sun Valley Arthritis Center Ltd. /ID# 200270Verified postcodePeoria, United States
- AZ Arthritis and Rheumotology Research, PLLC /ID# 209873Verified postcodePhoenix, United States
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875Verified postcodeTucson, United States
- Southern Arizona VA Health Care System /ID# 209247Verified postcodeTucson, United States
- Arthritis and Rheumatism Associates /ID# 209882Verified postcodeJonesboro, United States
- Valerius Medical Group & Research Center /ID# 207428Verified postcodeLos Alamitos, United States
- Rheumatology Center of San Diego /ID# 201642Verified postcodeSan Diego, United States
- Inland Rheum Clin Trials Inc. /ID# 201641Verified postcodeUpland, United States
- Medvin Clinical Research /ID# 211127Verified postcodeWhittier, United States
- New England Research Associates, LLC /ID# 207237Verified postcodeBridgeport, United States
- Danbury Clinical Research, LLC /ID# 209517Verified postcodeDanbury, United States
Common questions
What is psoriatic arthritis?
Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis. It causes joint pain, swelling, and stiffness, and can also affect other parts of the body.
What is risankizumab?
Risankizumab is a medicine that targets a specific part of the immune system to help reduce inflammation caused by conditions like psoriatic arthritis and psoriasis.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used in studies to see if the new medicine works better than no treatment at all.
How long will I be in this study?
The study is quite long, lasting for a total of about 6 and a half years including follow-up, with regular visits throughout this time.
Can I stop participating in the study if I want to?
Yes, you are free to leave the study at any time, for any reason, without it affecting your ongoing 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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