A Randomized Open Label Trial Exploring the Soluble and Imaging Biomarker Dynamic Responses to Tolebrutinib Compared to Rituximab Treatment in Patients with Multiple Sclerosis (MS)
This research is looking into treatments for Multiple Sclerosis (MS). It's a key study (Phase III), meaning it's well into testing new approaches. The trial will compare two existing treatments: Tolebrutinib and Rituximab. Doctors want to see how these medicines affect special markers found in the fluid surrounding your brain and spinal cord, called cerebrospinal fluid (CSF), and also in your blood. These markers can give clues about nerve damage and how the body's defence system is working. The main goal is to find out which treatment is better at reducing a specific marker that indicates nerve damage after 12 months. This could help doctors understand which treatment is more effective at slowing down MS progression.
At a glance
What is this study about?
This clinical trial is all about finding better ways to treat Multiple Sclerosis (MS). MS is a condition that affects your brain and spinal cord, and it can cause a range of symptoms. Doctors are always looking for treatments that can help slow down the disease and protect nerve cells from damage. This study is a 'Phase III' trial, which means these treatments have already been tested quite a bit and are now being carefully compared in a larger group of people to confirm how well they work and if they are safe.
The study will compare two different medicines: Tolebrutinib and Rituximab. Both of these are used to treat MS. The researchers want to see how these medicines affect certain things in your body that can tell us about your MS. For example, they're particularly interested in something called NfL (Neurofilament Light Chain) in the fluid around your brain and spine, and also in your blood. Higher levels of NfL can sometimes mean there's more nerve damage happening. By checking these levels before and after treatment, doctors hope to understand which medicine is better at protecting your nerves.
Beyond NfL, the study will also look at other markers in your blood and spinal fluid. These include markers that show how your body's immune system (its defence system) is working, and others that might give clues about inflammation or how nerve connections are functioning. By gathering all this information, the hope is to get a really clear picture of how these two treatments work inside the body, and ultimately, to help people with MS have better outcomes.
Key takeaways
- This study compares two MS treatments: Tolebrutinib and Rituximab.
- It aims to see which treatment is better at protecting nerves and reducing disease activity.
- Researchers will check markers in blood and spinal fluid over two years.
- The study is a Phase III trial, meaning it's a key stage in confirming treatment effectiveness.
- Participation involves regular clinic visits and sample collection.
- You have the right to leave the study 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. There is no upper age limit, so people of many ages can take part. Both men and women are welcome to participate in this research.
There will be other, more detailed requirements that the study doctors will discuss with you. These usually depend on your specific health history and your MS condition to make sure the study is safe and appropriate for you.
- Are you 18 years old or older?
- Do you have a diagnosis of Multiple Sclerosis?
- Are you able to attend regular clinic visits and have blood tests and a spinal fluid collection (lumbar puncture)?
- Are you willing for your treatment to be chosen by chance (randomly)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will be given one of the two medicines being tested: Tolebrutinib or Rituximab. Which one you receive will be decided by chance, like flipping a coin. You wouldn't know which drug you are getting, and neither would your study doctor, to make the comparison as fair as possible. Over the course of the study, you would have regular visits to the clinic (at 12 months and 24 months). During these visits, the study team would take samples of your blood and also collect a small sample of the fluid from around your spine (this procedure is called a lumbar puncture) to check the markers mentioned earlier. You would also have other medical checks to see how you are doing and how the treatment is affecting you. The total duration of the study for each participant will be 24 months, which is two years.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What is the main purpose of this study?
The main purpose is to compare how two MS treatments, Tolebrutinib and Rituximab, affect biological markers that show nerve damage and inflammation over time.
What are 'biomarkers'?
Biomarkers are substances in your body, like in blood or spinal fluid, that can give doctors clues about your health, disease activity, or how a treatment is working.
Will I know which treatment I am receiving?
No, this is a 'blinded' study, meaning neither you nor your doctors will know which of the two treatments you are getting. This helps ensure fair results.
What does 'Phase III' mean?
Phase III means the study is in its final stages of testing, comparing a new or repurposed treatment to existing ones in a larger group of people to confirm its effectiveness and safety.
How long would I be involved in the study?
Your involvement in this study would last for 24 months, which is two years.
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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