Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity
This study is for adults in Canada who are starting a medicine called brodalumab for their psoriasis. Researchers want to understand how this treatment impacts their daily lives, including their overall quality of life and how well they can work. It's an observational study, meaning doctors will simply watch and collect information over 12 months from people already taking brodalumab as part of their usual care. Around 500 people will take part across many different clinics. The study aims to gather real-world information on how this medicine works for people with psoriasis in their everyday lives.
At a glance
What is this study about?
This study is called the "Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis." That's a bit of a mouthful, so let's break it down. "Real World Evidence" means the researchers want to see how a medicine called brodalumab (you might know it by its brand name, SILIQ) works for people with psoriasis in their everyday lives, outside of very controlled special study settings.
The main goal is to understand how taking brodalumab affects important things like your quality of life – meaning how well you feel, how much your skin bothers you, and how easily you can do daily activities. They also want to see if it helps with work productivity, such as how often you miss work or how much your psoriasis affects your ability to do your job.
This isn't a study where you'd be given brodalumab to try for the first time. Instead, it's for adults with psoriasis in Canada who have already decided with their doctor to start brodalumab. The study will simply observe and collect information from these patients over a year to see what happens as they take their new medication. This helps doctors and researchers understand the benefits of brodalumab better for a wider group of people.
Key takeaways
- This study is for adults with psoriasis in Canada who are starting brodalumab (SILIQ).
- It aims to understand how brodalumab affects daily life, quality of life, and work over 12 months.
- Participation involves giving consent and regularly filling out online surveys about your health.
- You must already be prescribed brodalumab as part of your routine care; the study doesn't provide the medicine.
- The study helps develop a better understanding of brodalumab's effects in real-world settings.
- You can leave the study at any time without affecting your medical treatment.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. You must also be about to start taking brodalumab (SILIQ) for your psoriasis as part of your regular medical care, and you shouldn't have received your first dose yet. It's important that the decision to use brodalumab was made between you and your doctor before you were even asked about this study.
You also need to be able to read and understand information in either English or French, and you should be comfortable using an online platform to complete forms and answer questions. If you have Crohn's disease or are allergic to brodalumab or any of its ingredients, you won't be able to join. Also, if you're taking part in another clinical trial that involves a new treatment, or have done so recently, you wouldn't be able to join this one.
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?
- Are you about to start brodalumab (SILIQ) for your psoriasis, but haven't taken your first dose yet?
- Was the decision to take brodalumab made with your doctor, separate from this study?
- Can you comfortably read and communicate in English or French?
- Are you able to fill out online questionnaires using a computer or phone?
- Do you *not* have Crohn's disease or a known allergy to brodalumab?
What does participation involve?
If you decide to take part, you'll first give your verbal permission, and then receive an online informed consent form to read and sign electronically to confirm you understand and agree. After that, the study will simply follow your progress with brodalumab over 12 months. You won't be given any experimental medication; you'll take brodalumab exactly as prescribed by your doctor for your psoriasis.
Throughout the 12 months, you'll be asked to regularly fill out questionnaires online (sometimes called ePROs – electronic Patient Reported Outcomes). These questions will ask about your psoriasis, your quality of life, and how it affects your work. You'll need a computer or mobile device to complete these. The doctors involved will also collect information from your routine clinic visits. You can expect the study to last for about 12 months from the time you enrol.
Potential risks and benefits
Locations (42)
- CARE Site 42Verified postcodeCalgary, Canada
- CARE Site 26Verified postcodeCalgary, Canada
- CARE Site 15Verified postcodeCalgary, Canada
- CARE Site 18Verified postcodeEdmonton, Canada
- CARE Site 41Verified postcodeEdmonton, Canada
- CARE Site 21Verified postcodeEdmonton, Canada
- CARE Site 37Verified postcodeEdmonton, Canada
- CARE Site 28Verified postcodeSherwood Park, Canada
- CARE Site 31Verified postcodeVancouver, Canada
- CARE Site 36Verified postcodeWinnipeg, Canada
- CARE Site 12Verified postcodeWinnipeg, Canada
- CARE Site 35City onlySaint Johns, Canada
Common questions
What is brodalumab?
Brodalumab (brand name SILIQ) is a prescription medicine used to treat moderate to severe plaque psoriasis in adults.
Do I have to take brodalumab for this study?
No, you must have already decided with your doctor to start brodalumab for your psoriasis as part of your routine care to be eligible for this study. The study doesn't involve starting a new medicine you weren't already going to take.
What does 'observational study' mean?
It means the doctors will simply watch and collect information about your health and how you're doing while you take brodalumab as you normally would. You won't be asked to do anything extra or different than what your doctor prescribes for your treatment.
How long will I be in the study?
If you join, the study will follow your progress for 12 months.
What does a 'Patient Support Program' (PSP) do?
A Patient Support Program often helps patients access their medication, provides educational materials, and offers support throughout their treatment journey.
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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