Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT - physician’s choice in the treatment of newly diagnosed RMS (STHENOS)

This research study, called STHENOS, is investigating a new treatment for relapsing multiple sclerosis (RMS) called ofatumumab. RMS is a type of MS where symptoms come and go. The study is comparing ofatumumab to other common MS medicines that are currently available. We want to find out how well ofatumumab works to prevent new MS symptoms, reduce damage seen on brain scans (MRI), and stop disability from getting worse. This is an important step to see if ofatumumab could be a good new option for people newly diagnosed with RMS. Scientists will be looking closely at information such as how many MS attacks people have, changes in their disability, and any side effects over time. This helps us understand the treatment's safety and effectiveness.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novartis Pharma AG

Enrolment target

186

Start

27 Jun 2024

relapsing multiple sclerosis (RMS)

What is this study about?

This study is a research project looking into a new treatment for multiple sclerosis (MS) called ofatumumab. MS is a condition that affects your brain and spinal cord, causing a range of symptoms. In this study, we are focusing on a particular type of MS called relapsing multiple sclerosis (RMS). With RMS, people experience periods when their symptoms get worse (relapses or MS attacks), followed by periods of recovery. The main goal of this study is to see if ofatumumab is a safe and effective treatment for people who have been recently diagnosed with RMS.

To do this, we are comparing ofatumumab to other standard MS medications that doctors might typically prescribe first. This comparison will help us understand if ofatumumab is better, similar, or worse than existing treatments. Researchers will be carefully observing participants to see if the treatments help prevent new MS attacks, reduce any new changes in the brain seen on MRI scans, and stop disability from progressing. They will also be looking closely at any side effects people might experience with either treatment.

The study aims to achieve what's called 'NEDA-3 status'. This fancy term simply means: no new MS attacks, no new or worsening spots on brain scans (MRIs), and no noticeable worsening of disability over a certain period. By understanding how often people achieve NEDA-3, the study hopes to find out which treatment gives people the best chance of living without their MS symptoms getting worse. This kind of research is vital for finding new and better ways to manage MS and improve the lives of those living with the condition.

Key takeaways

This study compares a new MS treatment (ofatumumab) with standard MS drugs.
It's for adults newly diagnosed with Relapsing Multiple Sclerosis (RMS).
The main goal is to prevent MS attacks and stop the disease from getting worse.
Participants will have regular check-ups, blood tests, and MRI scans.
The study aims to see which treatment best achieves 'No Evidence of Disease Activity' (NEDA-3).

Who may be eligible?

This study is looking for adults aged 18 and over, regardless of whether they are male or female, who have been recently diagnosed with a specific type of multiple sclerosis called Relapsing Multiple Sclerosis (RMS).

To be considered for the study, you would need to meet certain health criteria that the doctors involved in the study would explain in detail. This ensures that the study is safe and appropriate for everyone taking part. For instance, they would check your medical history and current health to make sure the study treatment wouldn't interfere with any other conditions or medications you might have.

Basically, the study is for adults who have RMS and are about to start their first disease-modifying treatment for the condition. Your doctor will be able to tell you if you are a good fit for this research.

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?
Have you been recently diagnosed with Relapsing Multiple Sclerosis (RMS)?
Are you considering starting your first treatment for MS?
Are you able to attend regular clinic appointments and have MRI scans?
Are you happy for your treatment to be decided randomly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug ofatumumab or one of the standard MS treatments. You wouldn't get to choose which one, as this is decided randomly to make the study fair. Ofatumumab is given as an injection under the skin once a month. The other standard treatments are also often given as injections or sometimes as tablets, and your doctor would decide which of these you would receive if you're not given ofatumumab.

You would have regular visits to the clinic for medical check-ups, blood tests, and MRI brain scans. These appointments are important for monitoring your health, how the treatment is working, and checking for any side effects. You might also be asked to keep a diary of your symptoms or any side effects you experience. The study will last for a certain period, and throughout this time, different aspects of your health and MS progression will be carefully assessed. It's a long-term commitment to gather enough information about the treatments.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as gaining early access to new treatments like ofatumumab that aren't yet widely available, and receiving close medical monitoring. However, there are also potential risks, including side effects from the study medication, which could range from mild to serious, and the possibility that the treatment might not be effective for you. You also might be placed in the group receiving a standard treatment rather than the new one. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Germany
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Unverified
Italy
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Unverified
Spain

Common questions

What is Relapsing Multiple Sclerosis (RMS)?

RMS is a type of MS where you have periods of new or worsening symptoms (called relapses or attacks) followed by periods of recovery.

What is NEDA-3 status?

NEDA-3 stands for 'No Evidence of Disease Activity'. It means no new MS attacks, no new or growing spots on your brain scans, and no worsening of your disability.

Will I know which treatment I'm getting?

No, in this study, you won't know if you're getting ofatumumab or a standard MS drug. This is done to make the study results fair and unbiased.

What is an MRI scan?

An MRI scan is a type of body scan that uses strong magnets and radio waves to create detailed pictures of organs and structures inside your body, like your brain.

Is ofatumumab a new drug?

Yes, ofatumumab is a newer treatment for MS that is being tested to see how it compares to existing, established medications.