A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to evaluate efficacy and safety of secukinumab administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with polymyalgia rheumatica (PMR)
This research study is investigating a new medication called secukinumab for people living with polymyalgia rheumatica (PMR). The aim is to see if secukinumab, when given with a steroid medicine (like prednisone), can help manage PMR symptoms effectively. Some participants will receive secukinumab, while others will get a placebo (an inactive dummy treatment) to compare their effects. The study is organised so neither the participants nor their doctors know who is getting which treatment, which helps ensure fair results. Researchers will monitor if the new medicine helps people feel better and potentially reduce their reliance on steroid medicines, which can have side effects. The study also looks at how safe the new medication is.
At a glance
What is this study about?
Imagine you have polymyalgia rheumatica (PMR), a condition that can cause stiffness and pain in your shoulders and hips. Currently, steroid medicines like prednisone are a common treatment. While they can be very helpful, using them for a long time can sometimes lead to side effects.
This study is looking into a new medicine called secukinumab. Researchers want to find out if taking secukinumab along with your usual steroid medicine can help you manage your PMR symptoms better. They are particularly interested in whether this combination allows you to gradually reduce the amount of steroid medicine you take while still keeping your PMR under control. This could potentially mean fewer steroid-related side effects for you.
To make sure the results are fair and reliable, this study uses a 'double-blind' approach. This means that neither you nor your study doctor will know whether you are receiving the new medicine (secukinumab) or a placebo (a dummy treatment that looks just like the real medicine but has no active ingredients). Everyone in the study will also be on a plan to gradually reduce their steroid medicine. Researchers will carefully track your symptoms, how much steroid medicine you're taking, and any side effects over about a year to understand how well secukinumab works and if it's safe.
Key takeaways
- This study is testing a new medicine for polymyalgia rheumatica (PMR).
- It aims to see if the new medicine, secukinumab, can help reduce symptoms and allow you to take less steroid medicine.
- You would receive either secukinumab or a dummy treatment (placebo) by injection.
- The study lasts about one year, with regular clinic visits.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be part of this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
Beyond your age and sex, there will be other specific health requirements that a doctor involved in the study will check. These might include how long you've had PMR, what other medicines you're taking, and your general health. These checks are important to make sure the study is right for you and that the results are meaningful for people with PMR.
It's important to remember that not everyone with PMR will be able to join. If you're interested, the study doctors will go through a full list of criteria with you to see if you're a good fit.
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?
- Do you have a confirmed diagnosis of polymyalgia rheumatica (PMR)?
- Are you generally able to attend regular clinic appointments for about a year?
- Are you willing to consider taking an experimental medicine (or a placebo) in combination with your prednisone?
- Are you able to follow specific instructions for taking medication and reporting symptoms?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine, secukinumab, or a placebo (dummy medicine) as an injection, along with a plan to gradually reduce your prednisone dose. You would have regular visits to the clinic over a period of 52 weeks, which is about one year.
During these visits, the study team would check your health, ask about your symptoms (like pain and stiffness), and monitor your prednisone dosage. They would also take blood and urine samples and measure your vital signs (like blood pressure and heart rate) to see how the treatment is working and check for any side effects. You might also fill out questionnaires about how you're feeling and how PMR affects your daily life. The total duration of your active participation would be about 52 weeks.
Potential risks and benefits
Locations (15)
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedFinland
- —UnverifiedIceland
Common questions
What is polymyalgia rheumatica (PMR)?
PMR is a condition that causes stiffness and pain, especially in the shoulders and hips, often worse in the morning.
What is secukinumab?
Secukinumab is a medicine being tested to see if it can help people with PMR. It's given by injection.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It's used for comparison.
Why is the study 'double-blind'?
Double-blind means neither you nor your doctor knows if you're getting the active medicine or the placebo. This helps ensure fair and unbiased results.
How long will the study last if I join?
Your active participation in the study would last for about 52 weeks, which is roughly one year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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