RecruitingOBSERVATIONAL

A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis

This study is for people in Germany with Multiple Sclerosis (MS). It's an observational study, meaning researchers will simply watch and collect information about how MS is being managed, rather than telling doctors what to do. The main aim is to see if a specific blood test, called serum neurofilament light (sNfL), can help doctors predict how active MS is and make better treatment decisions. Participants will either continue their existing MS medication or switch to a different one called ofatumumab. Researchers will collect data for up to two years, focusing on how sNfL test results are used in day-to-day care. This will help understand if this blood test can improve how MS is treated.

At a glance

Status

Recruiting

Sponsor

Novartis Pharmaceuticals

Enrolment target

700

Start

28 Oct 2024

Estimated completion

29 Nov 2028

Multiple Sclerosis

What is this study about?

This study is looking into how a simple blood test, called serum neurofilament light, or sNfL, can help doctors understand and manage Multiple Sclerosis (MS) better. Think of sNfL as a marker that can show if your nerve cells are being damaged. Doctors in Germany are already routinely using this test, and this study will observe how their decisions are made based on its results.

The main idea is to see if sNfL helps doctors predict how active MS is and if it leads to better choices about treatment. The study will follow people with MS who are already on certain medications. Some might continue their current treatment, while others might switch to a different medication called ofatumumab. The study won't ask doctors to change their usual practice; it will simply observe what they do and how sNfL plays a role in their decisions.

Over a period of up to two years, researchers will collect information during your regular doctor visits. This will help them understand if using the sNfL test can improve how MS is managed and ultimately lead to better outcomes for patients. It's about learning from real-world medical care.

Key takeaways

The study explores if a blood test (sNfL) can help manage MS.
It observes how doctors use sNfL results in real-world care.
You'll continue your usual MS treatment, decided by your doctor.
Participation involves no extra tests or visits beyond your routine care.
It aims to improve understanding of MS treatment decisions.
This is an observational study, not a drug trial.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) living with relapsing multiple sclerosis (RMS). You must have already been taking an approved MS medication from a specific group (known as 'category 1 DMTs') for at least three months, and your doctor must be following the standard guidelines for your treatment.

Crucially, you also need to have had a recent sNfL blood test (within the last three months) that your doctor is considering as part of your treatment plan. This means your doctor is already using this particular test to help them manage your MS care.

There are a few reasons you wouldn't be able to join. For example, if your current MS medication isn't being used exactly as approved, or if you're already taking part in another clinical study involving new treatments or a similar Novartis-sponsored study with ofatumumab.

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 relapsing multiple sclerosis (RMS)?
Have you been on an approved MS treatment (Category 1 DMT) for at least 3 months?
Have you had a sNfL blood test within the last 3 months?
Is your doctor using your sNfL results to help make treatment decisions?
Are you not currently in another drug trial or certain other observational studies?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given any new or experimental treatments. The study will simply observe your regular medical care as decided by your doctor. This means you will continue with your usual appointments, tests, and medications (either continuing your current MS treatment or switching to ofatumumab) as your doctor recommends.

The study will collect information from your routine visits for up to two years. The number and timing of these visits will be just like your usual check-ups, decided by your doctor based on your clinical needs. There are no extra tests or appointments specifically for the study. The information collected will include details about your sNfL blood test results and how these, along with other factors, guide your doctor's treatment decisions.

Potential risks and benefits

Because this study only observes your regular medical care and doesn't ask you to do anything different than what your doctor normally recommends, there are no additional risks directly from being in the study itself. You'll continue to receive your usual MS treatment and care. A potential benefit is that the study could eventually help other MS patients by improving our understanding of how the sNfL blood test can lead to better treatment decisions. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (109)

Novartis Investigative Site
Verified postcode
Albstadt, Germany· Recruiting
Novartis Investigative Site
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Hettingen, Germany· Recruiting
Novartis Investigative Site
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Mannheim, Germany· Recruiting
Novartis Investigative Site
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Schwetzingen, Germany· Recruiting
Novartis Investigative Site
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Bamberg, Germany· Recruiting
Novartis Investigative Site
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Neuburg A.d. Donau, Germany· Recruiting
Novartis Investigative Site
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Regensburg, Germany· Recruiting
Novartis Investigative Site
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Unterhaching, Germany· Recruiting
Novartis Investigative Site
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Untermeitingen, Germany· Recruiting
Novartis Investigative Site
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Weiden in Der Oberpfalz, Germany· Recruiting
Novartis Investigative Site
Verified postcode
Wolfratshausen, Germany· Withdrawn
Novartis Investigative Site
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is sNfL?

sNfL stands for serum neurofilament light. It's a protein that gets released into your blood when nerve cells are damaged, and doctors are interested in using it as a marker for MS activity.

Will I have to take a new medication?

Not necessarily. Your doctor will decide whether you continue your current MS treatment or switch to ofatumumab, based on what they think is best for you and your sNfL results.

How long will I be in the study?

The study will collect information during your regular doctor visits for a maximum of two years.

Do I have extra appointments for the study?

No, you don't. All the information for the study will be gathered during your usual, routine medical appointments.

Is this a drug trial?

No, it's an 'observational' study. This means researchers are just watching and collecting information about real-world treatment decisions, not testing a new drug or telling doctors what to prescribe.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.