A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study
This research study, called RECLAIIM, is looking into a new treatment for dermatomyositis. This is a condition that can cause muscle weakness and skin rashes. The study will test a medicine called Hizentra, which is given as an injection under the skin. We want to find out if Hizentra helps improve symptoms more than a dummy treatment (placebo) and if it is safe to use. Researchers will observe participants closely over several weeks to see how their symptoms change, especially muscle strength and skin problems. The main goal is to find out if enough people taking Hizentra show significant improvement without needing extra steroid medication. This could lead to a new treatment option for those living with dermatomyositis.
At a glance
What is this study about?
Dermatomyositis is a long-term condition that mainly affects your muscles and skin. It can make your muscles weak and tired, and cause a rash on your skin. Scientists are always trying to find better ways to help people manage their symptoms and improve their quality of life. This study, called RECLAIIM, is testing a new medicine called Hizentra to see if it can help people with dermatomyositis.
Hizentra is a type of medicine that helps support your immune system, which is your body's natural defence against illness. It's already used for other immune conditions, but researchers want to see if it can specifically help people with dermatomyositis. The study will compare Hizentra to a "dummy" treatment, called a placebo, which looks just like the real medicine but doesn't contain any active ingredients. This helps researchers understand if any improvements are truly due to the medicine or something else.
The main aim of the study is to see how many people taking Hizentra show a significant improvement in their dermatomyositis symptoms, particularly muscle strength and skin issues. They will also be checking to see if people can reduce their reliance on steroid medications, which are often used to treat the condition but can have side effects. The study will also carefully check if the new medicine is safe and if there are any side effects. Your safety and well-being will always be the top priority.
Key takeaways
- This study is for adults with dermatomyositis.
- It tests a new medicine called Hizentra, given as an injection, against a dummy treatment.
- The main goals are to see if Hizentra improves symptoms and is safe.
- Participation involves regular clinic visits for assessments and treatment.
- You will be closely monitored by medical professionals.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to take part.
There will be other specific health requirements that the study doctors will discuss with you. These are in place to make sure the study gathers good information and that it is safe for you to participate.
If you have questions about whether you might be suitable, it's best to speak directly with the study team or your own doctor.
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 diagnosis of dermatomyositis?
- Are you able to attend regular clinic visits?
- Are you willing to receive injections under your skin?
- Are you comfortable potentially receiving a placebo (dummy treatment)?
What does participation involve?
If you decide to join this study, you would first have a healthcare professional explain everything in detail and answer all your questions. If you agree, you would then provide your consent.
The study treatment, either Hizentra or the dummy treatment, is given as an injection under the skin. You would receive regular doses over a period of time. You would have several visits to the clinic or hospital, initially more frequently, where doctors and nurses would perform various checks. These check-ups would include assessing your muscle strength, examining your skin, and asking about your symptoms. They would also take blood and urine samples and monitor any side effects. The main part of the study involves receiving treatment for around 24 weeks, followed by further monitoring, possibly up to a year. The total duration of your involvement could be around 53 weeks, or roughly a year.
Potential risks and benefits
Locations (7)
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedPoland
Common questions
What is dermatomyositis?
It's a long-term condition that causes muscle weakness and skin problems. It's related to the immune system.
What is Hizentra?
It's a medicine given by injection under the skin that helps support your immune system. We're testing if it helps dermatomyositis.
Will I get the actual medicine or a dummy treatment?
Participants will be randomly assigned to either receive Hizentra or a placebo (dummy treatment), so neither you nor the doctors will know which one you are getting at first.
How long will I be in the study?
The main treatment part is about 24 weeks, but your total involvement with follow-up could be around 53 weeks (just under a year).
Can I stop participating at any time?
Yes, you have the right to leave the study at any point, for any reason, without it affecting your 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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