Not recruiting

Study on Personalized Ocrelizumab Dosing 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 (MS), specifically the relapsing-remitting type, which is a condition where the immune system mistakenly attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. The treatment being tested is called Ocrevus, which is a medication given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The study is comparing two approaches to using Ocrevus: a personalized dosing method tailored to each patient's needs and the standard method, which follows a fixed schedule.

The purpose of the study is to determine if the personalized dosing of Ocrevus is as effective as the standard dosing in controlling the activity of Multiple Sclerosis. Participants in the study will receive either the personalized or standard treatment and will be monitored over a period of time to assess the effectiveness of the treatment in preventing relapses and the development of new or enlarging lesions in the brain, which are areas of damage that can be seen on an MRI scan.

Throughout the study, participants will undergo regular check-ups and MRI scans to track their progress. The study aims to provide valuable information on whether adjusting the treatment to each individual's needs can offer the same benefits as the traditional approach, potentially leading to more tailored and effective care for people with Multiple Sclerosis.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria, ensuring the patient is 18 years or older, and has an EDSS score between 0 and 6.5.
The patient must have been treated with ocrelizumab for at least 48 weeks, which includes two 300 mg infusions and one 600 mg infusion. The interval between the last ocrelizumab infusion should not exceed 7.5 months.
Step 2
Treatment allocation
The patient is randomly assigned to one of two treatment groups: the personalized B cell tailored ocrelizumab group or the standard ocrelizumab group.
The standard group receives ocrelizumab at a fixed interval of every 24 weeks.
Step 3
Treatment administration
Ocrelizumab is administered as an intravenous infusion. The dosage and frequency depend on the assigned treatment group.
The personalized group may receive adjusted dosages based on specific B cell levels, while the standard group receives a fixed dosage.
Step 4
Follow-up assessments
Regular follow-up assessments are conducted to monitor the patient's health and the effectiveness of the treatment.
These assessments include checking for any relapses and conducting MRI scans to detect new or enlarging T2 lesions.
Step 5
End of study evaluation
After 96 weeks, a final evaluation is performed to compare the percentage of relapse-free patients and the presence of new or enlarging T2 MRI lesions between the two treatment groups.
The study aims to demonstrate that the personalized treatment is not inferior to the standard treatment in controlling disease activity.

Who can join the trial?

5 criteria

You must have a current diagnosis of **relapsing-remitting multiple sclerosis**. This is a type of multiple sclerosis where symptoms flare up and then improve.
You need to be **18 years old or older**.
Your **EDSS score** should be between 0 and 6.5. The EDSS score is a way to measure how much multiple sclerosis affects your ability to move and do daily activities.
You must have been treated with **ocrelizumab** for at least 48 weeks. This means you should have received two 300 mg infusions and one 600 mg infusion of the medication.
Your last **ocrelizumab treatment interval** should not have been extended beyond 7.5 months between infusions. This means you should have received your treatments on time without long delays.

Who cannot join the trial?

5 criteria

Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to the study medication cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who are unable to follow the study procedures cannot participate.

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Verified sites

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

Amphia Hospital
Verified
Breda, The Netherlands
Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

Ocrelizumab: This medication is used to treat relapsing-remitting multiple sclerosis (MS). It works by targeting and reducing the activity of certain immune cells called B cells, which are involved in the abnormal immune response that damages the nervous system in MS. The trial is comparing a personalized approach to administering ocrelizumab, tailored to the patient's B cell levels, against the standard treatment schedule.

Ocrelizumab

What is already known about the treatment

Ocrelizumab – This medication is administered through an intravenous infusion, typically given in a healthcare setting. It is currently approved and widely used in the treatment of multiple sclerosis, specifically for relapsing forms of the disease. Ocrelizumab works by targeting and depleting B cells, a type of white blood cell that plays a role in the immune system's attack on the nervous system in multiple sclerosis. It is classified as a monoclonal antibody, which is a type of biologic drug designed to interact with specific proteins in the body.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It occurs when the 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, this can cause permanent damage or deterioration of the nerves themselves. The disease often begins with episodes of symptoms that may include fatigue, difficulty walking, numbness, and vision problems. These symptoms can vary widely among individuals and may come and go, with periods of remission and relapse. As the disease progresses, it can lead to more severe physical and cognitive impairments.