Open-Label, Randomized, Multicenter, Multi-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children from 10 to Less Than 18 Years of Age with Relapsing-Remitting Multiple Sclerosis with Optional Open-Label Extension (CONNECT)
This research study, called CONNECT, is looking for children and teenagers (aged 10 to under 18) who have a type of multiple sclerosis (MS) called Relapsing-Remitting MS. The main goal is to test a new medicine, BG00012, to see if it can help stop new areas of damage appearing on the brain, as seen on MRI scans. Researchers will also be carefully checking for any side effects the medicine might cause. Participants will be compared to others receiving a standard MS treatment. The study is split into two parts: the first focuses on how well the medicine works over about two years, and the second continues to monitor safety. This type of study helps doctors understand if new treatments are safe and effective for young people with MS.
At a glance
What is this study about?
This study is designed to learn more about a potential new medicine, BG00012, for children and teenagers who have a specific type of multiple sclerosis (MS) called Relapsing-Remitting MS. This form of MS involves periods where symptoms get worse (relapses) followed by periods of recovery. The medicine being tested is an existing MS treatment known as TECFIDERA.
The main aim of the study is to see if BG00012 can reduce the number of new areas of damage that appear on the brain, which are visible on special MRI scans. Doctors also want to make sure the medicine is safe for young people and understand any side effects it might cause. They will compare BG00012 with a treatment that's already used for MS. This will help doctors decide if BG00012 could be a good treatment option for young people with MS in the future.
Over the course of the study, researchers will regularly check participants' brain scans and monitor for any new MS symptoms or relapses. They will also carefully record any side effects and assess participants' overall health, including their energy levels and how MS affects their daily lives. By doing this, they hope to gather important information about how well BG00012 works and if it's safe for this age group.
Key takeaways
- Tests a new medicine (BG00012) for young people with MS.
- Compares it to an existing MS treatment.
- Aims to reduce new MS brain lesions and check safety.
- Involves regular MRI scans and health checks.
- Main study lasts about two years, with optional extension.
Who may be eligible?
Anyone aged between 10 and under 18 who has been diagnosed with Relapsing-Remitting Multiple Sclerosis may be able to take part in this study. Both boys and girls can participate.
To be considered for the study, you would need to meet certain health criteria that the doctors in the study will explain. This helps ensure that the study is safe for you and that the results are clear.
It's important to remember that the study team will review your medical history carefully to make sure the study is right for 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 between 10 and under 18 years old?
- Do you have a diagnosis of Relapsing-Remitting MS?
- Are you able to attend regular hospital/clinic appointments?
- Are you willing to have regular MRI scans?
What does participation involve?
If you decide to take part, you'll be assigned to either receive the study medicine (BG00012) or an existing MS treatment. This will be chosen by chance, like flipping a coin. You will have regular visits to the hospital or clinic for check-ups, blood tests, and MRI scans of your brain. These scans will help doctors look for any new areas of MS activity.
Doctors will also regularly ask you about your symptoms, any side effects you might be experiencing, and how you are generally feeling, including your energy levels. They will also measure things like your height, weight, and general physical development.
This study involves a commitment over a period of up to 96 weeks (about two years) in the main part, with an option to continue in an additional extension part if you and your doctor agree. Throughout the study, the medical team will be there to support you and answer any questions you have.
Potential risks and benefits
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Common questions
What is Relapsing-Remitting MS?
It's a type of multiple sclerosis where you have periods when your MS symptoms get worse (called relapses) followed by times when they get better, but the condition can still progress over time.
What does a 'Phase III' study mean?
Phase III means this is a large study to confirm if a new medicine works well and is safe for a particular condition. It's usually the last step before a medicine might be approved for general use.
Will I definitely receive the new medicine?
No, you will be assigned by chance to either receive the study medicine (BG00012) or a standard, approved MS treatment. This is to fairly compare the two.
How long will the study last if I join?
The main part of the study lasts for about two years (96 weeks). There's also an option to continue into an additional 'extension' part of the study.
What are 'T2 hyperintense lesions'?
These are areas of damage or inflammation in the brain that doctors can see on special MRI scans. They are often signs of MS activity.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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