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Study on Anti-CD20 Therapy and Drug Combination for Patients with Relapsing-Remitting 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 Multiple Sclerosis, specifically the type known as Relapsing-Remitting Multiple Sclerosis. The study will compare two different treatment approaches. One approach involves continuing with a type of medication called anti-CD20 therapy, which includes drugs like Ocrelizumab and Rituximab. The other approach involves switching from anti-CD20 therapy to other treatments known as platform therapies, which include medications such as Ofatumumab, Dimethyl Fumarate, Diroximel Fumarate, Teriflunomide, Glatiramer Acetate, Peginterferon Beta-1a, and Interferon Beta-1a.

The purpose of the study is to see if switching to platform therapies is not worse than continuing with anti-CD20 therapy in terms of keeping the disease under control. Participants will be randomly assigned to one of the two treatment groups. The study will last for about three years, during which time participants will receive their assigned treatment and have regular check-ups. These check-ups will include clinical evaluations and MRI scans to monitor disease activity, which means looking for any new symptoms or changes in the brain that might indicate the disease is getting worse.

Throughout the study, researchers will also keep track of any relapses, changes in disability, and any side effects or infections that might occur. They will also measure certain substances in the blood, like B-cells and immunoglobulins, which are part of the immune system. Additionally, the study will look at brain volume and levels of a protein called neurofilament light chain, which can indicate nerve damage. The overall goal is to understand which treatment approach is better for managing the disease while considering the impact on quality of life and healthcare costs.

The research process

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

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a brain MRI scan performed within the last six months.

    Eligibility criteria include being 40 years or older, having relapsing-remitting multiple sclerosis, and having been treated with anti-CD20 therapy for at least the last three years without disease activity.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: the anti-CD20 maintenance group or the de-escalation strategy group.

    The goal is to compare the effectiveness of continuing anti-CD20 therapy versus switching to other treatments.

  3. Step 3

    Treatment phase

    In the anti-CD20 maintenance group, participants continue receiving their current anti-CD20 therapy, such as ocrelizumab or rituximab, through intravenous infusion at intervals determined by the study protocol.

    In the de-escalation strategy group, participants switch to one of several alternative treatments, which may include dimethyl fumarate (oral), glatiramer acetate (subcutaneous injection), or teriflunomide (oral). The specific medication, dosage, and frequency are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants attend regular follow-up visits to monitor health and treatment effectiveness. This includes clinical assessments and MRI scans to check for disease activity.

    The primary goal is to assess the percentage of participants without disease activity over a 36-month period.

  5. Step 5

    End of study

    At the end of the study period, a final assessment is conducted to evaluate the overall health and treatment outcomes.

    Participants may be asked to provide feedback on their experience and any side effects encountered during the trial.

Who can join the trial?

6 criteria

  • Patients must be **40 years or older** at the time of joining the study.
  • Patients must have **relapsing remitting multiple sclerosis**. This is a type of multiple sclerosis where symptoms flare up and then improve.
  • Patients must have been treated with **anti-CD20 therapy** for at least the last 3 years. Anti-CD20 therapy is a treatment that targets specific cells in the immune system.
  • If patients have been treated with **IV ocrelizumab** or **rituximab** at extended intervals, the time between treatments should not be more than 12 months during the year before joining the study. These are specific types of anti-CD20 therapies given through a vein.
  • There should be **no evidence of disease activity** for the last 3 years while on anti-CD20 therapy. This means no relapses (flare-ups of symptoms) and no new or enlarged lesions (damaged areas) on MRI scans.
  • A **brain MRI** must be performed according to the **OFSEP protocol** within a maximum of 6 months before joining the study. An MRI is a type of scan that creates detailed images of the brain.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Multiple Sclerosis cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

  • Anti-CD20 Therapy

    is a type of treatment that targets specific cells in the immune system called B cells. These cells can play a role in the development of multiple sclerosis (MS). By targeting and reducing the number of these B cells, this therapy aims to help control the disease and reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS). This therapy is often used as a maintenance treatment to keep the disease under control over time.

  • Platform Therapies

    are a group of treatments commonly used in managing multiple sclerosis. These therapies work in different ways to help reduce the number of relapses and slow the progression of the disease. They are considered standard treatments for MS and are often used when a patient transitions from a more intensive therapy, like anti-CD20 therapy, to a less intensive, ongoing treatment plan. The goal of platform therapies is to maintain disease stability and improve the quality of life for patients with MS.

What is already known about the treatment

Anti-CD20 therapy – This medication is administered through an injection, typically given by a healthcare professional. It is currently being studied in clinical trials for its effectiveness in treating relapsing-remitting multiple sclerosis (MS), a condition where the immune system mistakenly attacks the protective covering of nerves. The main goal of this therapy is to reduce disease activity by targeting and depleting B-cells, a type of white blood cell involved in the immune response. Anti-CD20 therapy is classified as a monoclonal antibody, which means it is designed to specifically target and bind to the CD20 protein on B-cells, helping to prevent further nerve damage in MS patients.

Investigated diseases

Multiple sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. The disease progresses with episodes of new or increasing neurological symptoms, known as relapses, which can vary in severity and duration. Over time, multiple sclerosis can lead to physical and cognitive disabilities as nerve damage accumulates. The progression of the disease can be unpredictable, with periods of remission and exacerbation. Brain MRI scans often show new or enlarged lesions, which are areas of damage in the brain tissue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513292-40-00Protocol codeRECHMPL23_0397Estimated enrolment250 patientsSponsorCentre Hospitalier Universitaire De Montpellier

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