Study Comparing Rituximab and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effects of two medications, Rituximab and Ocrelizumab, in patients with relapsing-remitting multiple sclerosis. Multiple sclerosis is a disease where the immune system mistakenly attacks the protective covering of nerves, which can lead to various physical and mental problems. The purpose of the study is to compare the effectiveness of Rituximab and Ocrelizumab in managing this condition.

Participants in the study will receive either Rituximab or Ocrelizumab, both of which are given as a solution for infusion, meaning they are administered directly into the bloodstream through a vein. The study will last for a period of two years, during which the health and progress of the participants will be monitored. The main goal is to see how many patients remain free of disease activity, which includes no new relapses or changes seen in MRI scans, over this time.

Throughout the study, various aspects will be assessed, such as the frequency of relapses, any progression in disability, and the overall quality of life of the participants. Additionally, the study will look at the safety of the treatments by recording any adverse events experienced by the participants. This trial aims to provide valuable information on the effectiveness and safety of these treatments for people living with relapsing-remitting multiple sclerosis.

1 initial visit and assessment

Upon joining the study, you will have an initial visit where your eligibility will be confirmed. This includes a review of your medical history and a physical examination.

You will undergo a brain MRI scan if you haven’t had one in the last six months. This is to check for any new or existing lesions in your brain.

You will be asked to sign an informed consent form, confirming your understanding and agreement to participate in the trial.

2 randomization and treatment assignment

You will be randomly assigned to receive either rituximab or ocrelizumab. This means you will not choose which medication you receive.

Both medications are given as a solution for infusion, which means they are administered through a drip into your vein.

3 treatment administration

If you are assigned to rituximab, you will receive the medication as an infusion. The specific dosage and frequency will be explained to you by the medical team.

If you are assigned to ocrelizumab, you will receive 300 mg of the medication as an infusion. The frequency and duration will be provided by the medical team.

4 regular follow-up visits

You will have regular follow-up visits every six months to monitor your health and the effectiveness of the treatment.

During these visits, you will undergo assessments such as physical exams, MRI scans, and questionnaires to evaluate your quality of life and any changes in your condition.

5 end of study evaluation

At the end of the two-year study period, you will have a final evaluation to assess your overall health and any changes in your condition.

The results of your participation will contribute to understanding the effectiveness of rituximab compared to ocrelizumab in treating relapsing-remitting multiple sclerosis.

Who Can Join the Study?

Patients must have a type of Multiple Sclerosis called relapsing-remitting MS. This means they have periods of new or worsening symptoms followed by periods of recovery.
Patients must have shown signs of disease activity, such as at least one relapse or a new brain lesion, in the last 12 months.
Patients must be between the ages of 18 and 55.
Patients must have an EDSS score of 5 or less. EDSS stands for Expanded Disability Status Scale, which measures the level of disability in people with Multiple Sclerosis.
Patients must have had a brain MRI scan within 6 months before joining the study. MRI stands for Magnetic Resonance Imaging, a type of scan that creates detailed images of the brain.
Women who can become pregnant must use effective birth control during the study and for 12 months after the last dose of the study medication. Effective birth control includes methods like birth control pills or intrauterine devices (IUDs).
Patients must have signed a form agreeing to participate in the study, known as an informed consent form.
Patients must have social insurance coverage.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Multiple Sclerosis cannot participate.
Patients who are not in the age range specified for the study cannot participate.
Patients who are part of a vulnerable population, meaning they need special protection, cannot participate.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have any other medical condition that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent infection or illness that could affect the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of allergic reactions to the study medications cannot participate.
Patients who have used certain medications recently that could interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Assistance Publique Hopitaux De Paris	Paris	France
Hospices Civils De Lyon	Lyon	France
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Centre Hospitalier General	Gonesse	France
Centre Hospitalier Universitaire De Nantes	Saint-Herblain	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Hopital Purpan	Toulouse	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
Groupe Hospitalier Rance Emeraude	Saint-Malo	France
Centre Hospitalier Intercommunal De Poissy Saint Germain	St Germain En Laye	France
Cujnmf Hjkpxfmuooa Eb Ubxvvugzwwyhe Do Ldjmwsu	Limoges	France
Avmgpicxmd Pwukpcou Hdmcdlva Da Mhjqtkfkb	Marseille	France
Cdts Do Ndpbt	Vandoeuvre Les Nancy	France
Hmciazg Hqwpl Mxhiqz &qdiftz 1 rpt Gewykle Eteydm	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.01.2023

Trial locations

Investigated drugs:

Rituximab is a medication used in this clinical trial to treat patients with relapsing-remitting multiple sclerosis (MS). It works by targeting specific cells in the immune system that are thought to play a role in the disease. By reducing the activity of these cells, rituximab may help decrease the frequency of relapses and slow the progression of MS symptoms.

Ocrelizumab is another medication being tested in the trial for relapsing-remitting multiple sclerosis. Similar to rituximab, ocrelizumab targets certain immune cells that contribute to the disease. The goal of using ocrelizumab is to reduce the number of relapses and manage the symptoms of MS, potentially improving the quality of life for patients.

Investigated diseases:

Relapsing-remitting multiple sclerosis

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 can progress in various forms, including relapsing-remitting, primary progressive, and secondary progressive types. In relapsing-remitting multiple sclerosis, patients experience episodes of new or worsening symptoms followed by periods of partial or complete recovery. Over time, some individuals may develop a steady progression of symptoms, known as secondary progressive multiple sclerosis. The progression of the disease can lead to physical and cognitive disabilities, with symptoms varying widely among individuals.

Trial ID:

2022-501027-25-01

Protocol code:

35RC20_9812

NCT ID:

NCT05758831

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study Comparing Rituximab and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

What is this study about?

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