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Study on the Effectiveness and Tolerability of Ofatumumab Compared to a Drug Combination for Patients with Newly Diagnosed Relapsing Multiple Sclerosis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of relapsing multiple sclerosis (RMS), a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The study will compare the effectiveness and tolerability of a medication called ofatumumab, which is given as a monthly injection under the skin, against other first-line treatments chosen by doctors. These treatments include dimethyl fumarate, diroximel fumarate, interferon beta-1a, glatiramer acetate, teriflunomide, and peginterferon beta-1a. Some of these medications are taken orally, while others are injected.

The purpose of the study is to evaluate how well ofatumumab works compared to these other treatments in people who have recently been diagnosed with RMS and have not yet received treatment. Participants will be randomly assigned to receive either ofatumumab or one of the other treatments. The study will last for about 15 months, during which participants will have regular check-ups to monitor their health and the effectiveness of the treatment. The study will also include a group receiving a placebo, which is a substance with no active medication, to help compare the results.

Throughout the study, researchers will look at various factors, such as the number of relapses, changes in disability levels, and any new brain lesions detected by MRI scans. The goal is to determine which treatment is more effective in preventing relapses and slowing the progression of the disease. Participants will be closely monitored for any side effects or adverse reactions to ensure their safety. This study aims to provide valuable information that could help improve treatment options for people with RMS.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient provides written consent and confirms stability in their neurological condition for at least one month prior to the first administration of the study medication.
The patient must be between 18 and 55 years old and have a diagnosis of relapsing multiple sclerosis (RMS) according to specific criteria.
The patient should not have received prior treatment for multiple sclerosis and must have experienced symptoms for five years or less.
Step 2
Randomization and treatment selection
The patient is randomly assigned to receive either ofatumumab or a first-line disease-modifying treatment (DMT) chosen by the physician.
First-line DMT options include glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate.
Step 3
Medication administration
If assigned to ofatumumab, the patient receives a 20 mg dose via subcutaneous injection once a month.
If assigned to a first-line DMT, the administration method and frequency depend on the specific medication chosen by the physician.
Step 4
Monitoring and assessments
Throughout the study, the patient undergoes regular assessments to monitor the absence of relapses and new MRI activity.
The patient is evaluated for any changes in disability status and the presence of new or enlarged brain lesions.
Step 5
Study duration
The study is conducted over a period of 15 months, with key assessments at months 3, 9, and 15.
The primary goal is to evaluate the effectiveness and tolerability of the assigned treatment.

Who can join the trial?

10 criteria

You must provide written informed consent before any assessment.
You should be neurologically stable, meaning no changes in your nervous system, within 1 month before the first study drug is given.
You can be a male or female between 18 and 55 years old.
You need to have a diagnosis of **multiple sclerosis (MS)** according to specific criteria from 2017.
You should have **relapsing multiple sclerosis (RMS)**, which means your MS symptoms come and go.
You must not have received any treatment for MS before, and it should be 5 years or less since your first MS symptom appeared.
Your **EDSS score**, which measures disability in MS, should be between 0 and 4.0.
You must be suitable for treatment with one of the first-line self-administered **disease-modifying therapies (DMTs)**, which are specific MS medications, or with ofatumumab, depending on the study's randomization and your doctor's choice.
You should have had at least 1 relapse or 1 **Gd+ enhanced lesion** on a T1 MRI scan in the year before the screening. A Gd+ enhanced lesion is a specific type of spot seen on an MRI scan that shows active inflammation in the brain.
You must be able to undergo an **MRI assessment**, which is a type of scan that takes pictures of your brain.

Who cannot join the trial?

5 criteria

Patients who have been previously treated for **relapsing multiple sclerosis (RMS)** cannot participate. This means if you have already received treatment for this condition, you are not eligible.
Patients who are not newly diagnosed with **RMS** are excluded. This means if you have known about your condition for a while, you cannot join the study.
Patients who are not **treatment naïve** are excluded. This means if you have already started any treatment for **RMS**, you cannot participate.
Patients who are not within the specified age range cannot participate. The study has specific age requirements that must be met.
Patients who are part of a vulnerable population may not be eligible. This includes groups that might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHU Gabriel-Montpied
Verified
Clermont Ferrand, France
CHU Grenoble Alpes
Verified
La Tronche, France
Centre Hospitalier De La Cote Basque
Verified
Bayonne, France

Trial locations

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Investigated drugs

Ofatumumab
is a medication used in this trial to treat patients with a condition called RMS. It is given as an injection under the skin once a month. The purpose of using ofatumumab in this study is to see how well it works and how well patients can tolerate it compared to other treatments.
First Line DMT (Disease-Modifying Therapy)
refers to the standard treatments chosen by doctors for patients who are newly diagnosed with RMS. These treatments are used to help manage the disease and reduce its symptoms. The study compares the effectiveness and tolerability of these standard treatments with ofatumumab.

What is already known about the treatment

Ofatumumab – Ofatumumab is administered as a subcutaneous injection, typically given once a month. It is currently being studied in clinical trials for its effectiveness in treating relapsing multiple sclerosis (RMS). The medication works by targeting and depleting B-cells, a type of white blood cell involved in the immune response, which are believed to play a role in the progression of multiple sclerosis. Ofatumumab is classified as a monoclonal antibody, and its use in RMS is being compared to other first-line disease-modifying therapies (DMTs) to assess its efficacy and tolerability.

Investigated diseases

Relapsing Multiple Sclerosis – Relapsing multiple sclerosis (RMS) is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms, known as relapses. These relapses are followed by periods of partial or complete recovery, called remissions. The disease involves an immune-mediated process where the body's immune system mistakenly attacks the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, RMS can lead to physical and cognitive disabilities. The progression of the disease varies among individuals, with some experiencing frequent relapses and others having long periods of stability. RMS is the most common form of multiple sclerosis at the time of diagnosis.