A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE)
This study is investigating a new medication, belimumab (also known as Benlysta), for children and teenagers who have systemic lupus erythematosus (SLE), commonly called lupus. We are trying to understand its safety when used with their current lupus treatments, how well it helps control their lupus symptoms, and how their bodies process the medicine. Participants will receive either belimumab or a placebo (a dummy medicine) through a drip. Doctors and patients won't know which one they are getting. This research aims to find out if belimumab can be a helpful new treatment option for young people living with lupus.
At a glance
What is this study about?
This study is like a detective mission, but instead of solving a mystery, we're trying to find out more about a medicine called belimumab, also known as Benlysta. It's for children and teenagers who have a condition called systemic lupus erythematosus, or lupus for short.
Lupus is a long-term condition where the body's immune system, which normally fights off infections, starts to attack its own healthy tissues and organs. This can cause many different symptoms, like joint pain, tiredness, skin rashes, and problems with kidneys or other organs. Managing lupus can be challenging, especially for young people.
We want to see if adding belimumab to the usual treatments for lupus can help. We'll be looking carefully to see if it's safe, if it helps improve lupus symptoms, and how the body uses the medicine. The study will compare belimumab with a placebo, which looks just like the real medicine but contains no active drug. This helps us understand if any improvements are genuinely due to belimumab and not just other factors.
Key takeaways
- This study is for children and teenagers with lupus (Systemic Lupus Erythematosus).
- It aims to test the safety and effectiveness of a new medicine called belimumab (Benlysta).
- You will receive either belimumab or a 'dummy' medicine (placebo) through a drip.
- Participation involves regular clinic visits for treatments and health checks.
- The study lasts approximately one year for treatment, with follow-up appointments.
- Your decision to join or leave the study will not affect your usual medical care.
Who may be eligible?
This study is looking for children and teenagers who have been diagnosed with systemic lupus erythematosus (lupus). Both boys and girls can take part. There are no specific age limits mentioned, meaning a wide range of young people with lupus might be able to join.
However, to ensure the study is safe and effective for everyone, there will be some specific medical checks. For example, your doctor will need to make sure your lupus is active enough to be studied but also that you are generally well enough to participate in a clinical trial. There will also be tests to ensure that the study medicine won't interfere with other medications you might be taking or pre-existing health conditions.
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.
- Do I have Systemic Lupus Erythematosus (lupus)?
- Am I a child or teenager?
- Am I generally well enough to participate in a study?
- Am I willing to attend regular clinic visits for treatment and check-ups?
- Am I currently receiving standard lupus treatment?
What does participation involve?
If you decide to take part, you'll be assigned by chance (like flipping a coin) to one of two groups: one will receive belimumab, and the other will receive a placebo (a dummy medicine that looks the same but has no active drug). You and your doctors won't know which one you're getting. Both groups will also continue with their usual lupus treatments.
The study medicine or placebo will be given to you through a drip into your arm (intravenously). You will have regular visits to the clinic for these treatments, as well as for various tests and check-ups. These checks will include blood tests, physical examinations, and questions about how you are feeling and any symptoms you might have. This allows the study team to monitor your health, how your lupus is responding, and if there are any side effects. The study will last for about 52 weeks (one year) of treatment, with follow-up appointments after that.
Potential risks and benefits
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Common questions
What is lupus (Systemic Lupus Erythematosus)?
Lupus is a long-term condition where your body's immune system mistakenly attacks healthy parts of your body, causing inflammation and damage to organs like joints, skin, kidneys, and more.
What is belimumab (Benlysta)?
Belimumab is a medicine designed to reduce the number of certain immune cells that can be too active in people with lupus, aiming to lessen the disease's effects.
What is a placebo?
A placebo is a substance that looks exactly like the study medicine but contains no active drug. It helps researchers fairly compare the real medicine's effects.
Will I know if I'm getting the study medicine or the placebo?
No, neither you nor your doctors will know whether you are receiving belimumab or the placebo. This is to make sure the study results are as fair and unbiased as possible.
How long will the study last?
The main part of the study where you receive treatment will last about 52 weeks (one year), followed by some additional check-up appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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