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Comparison of ocrelizumab and rituximab treatment in adults with active relapsing-remitting multiple sclerosis

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What is this trial about?

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

This clinical trial compares two treatments for Multiple Sclerosis (MS), a condition that affects the brain and spinal cord. The study focuses on people with the relapsing-remitting form of MS, which means symptoms come and go over time. The two medications being studied are ocrelizumab and rituximab, which are given through an infusion into a vein.

The main purpose of this research is to determine if rituximab works as well as ocrelizumab in treating people who have recently been diagnosed with relapsing MS. Both medications are designed to target certain cells in the immune system that are involved in MS. The study will monitor how well each treatment prevents new areas of damage in the brain that can be seen on MRI scans.

During the study, participants will receive their assigned medication through infusions over a period of 60 months. The total amount of medication given will not exceed 3000 mg. Throughout the study, participants will have regular brain scans and assessments to check their condition. The study will track various aspects of the disease, including how often relapses occur and whether there are any changes in physical abilities or thinking skills.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive either rituximab or ocrelizumab through an intravenous infusion (medication given directly into a vein)
The treatment will continue for 24 months (2 years)
Regular brain scans (MRI) will be performed at 6 months, 12 months, and 24 months to monitor your condition
Your physical abilities will be assessed using standardized tests
Step 2
Monitoring period
From months 24 to 30, your condition will be monitored to assess any changes in your symptoms
A brain scan will be performed at month 30
Your physical abilities will be evaluated again to compare with earlier results
Step 3
Extended follow-up
From month 30 to month 36, monitoring will continue with regular check-ups
Additional brain scans will be performed
Your physical abilities will continue to be assessed
Step 4
Long-term observation
From month 36 to month 60 (5 years total), you will continue to be monitored
Regular brain scans will track any changes in your condition
Physical ability assessments will continue throughout this period
Any side effects or changes in your health will be recorded

Who can join the trial?

14 criteria

Age between 18 and 60 years
Must have been diagnosed with relapsing-remitting multiple sclerosis within the last 12 months using McDonald criteria
Must have either:
- At least 1 disease relapse (temporary worsening of symptoms), or
- At least 1 new lesion seen on MRI scan in the last 12 months
- Must have an EDSS score of 4.0 or less (EDSS measures disability level in multiple sclerosis)
- Must not have previously received treatment for multiple sclerosis
- Must not have other medical conditions that would prevent participation
- Women who can become pregnant must agree to use highly effective birth control methods during the study and for several months after
- Must be able to:
  - Undergo MRI scans
  - Attend all treatment and follow-up visits
  - Understand written and spoken Norwegian or Swedish
  - Provide written informed consent
  - Must have previously completed the OVERLORD-MS trial and OVERLORD-SWITCH study
  - Must have stable disease with no relapses or new MRI lesions in the past 24 months

Who cannot join the trial?

14 criteria

Age below 18 or above 60 years
Previous treatment with rituximab or ocrelizumab (medications that affect the immune system)
Pregnancy or breastfeeding
Other forms of multiple sclerosis besides relapsing-remitting type
Severe infections or active chronic infections
History of severe allergic reactions to similar medications
Significant heart, liver, or kidney problems
Active cancer or history of cancer in the past 5 years
Participation in other clinical trials within the last 30 days
Use of other disease-modifying treatments for multiple sclerosis in recent months
Conditions that could interfere with MRI scanning (such as metal implants or severe claustrophobia)
Inability to provide informed consent
History of drug or alcohol abuse within the past year
Unstable medical or psychiatric conditions that could affect study participation

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Verified sites

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

Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Helse Bergen HF
Bergen, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

Rituximab is a medication that works by targeting specific immune cells called B-cells. It helps reduce inflammation in the body and is used to treat multiple sclerosis. It is given through an intravenous infusion (through a vein) in a medical setting. Ocrelizumab is also a medication that targets B-cells in the immune system. Like rituximab, it helps manage multiple sclerosis symptoms by reducing inflammation in the nervous system. It is administered as an intravenous infusion in a healthcare facility. Both medications work in similar ways to help treat relapsing-remitting multiple sclerosis by modifying how the immune system functions. They are considered disease-modifying therapies that can help reduce the frequency of MS relapses and slow down the progression of the disease.

What is already known about the treatment

Rituximab
An intravenously administered monoclonal antibody medication that targets B-cells in the immune system by binding to the CD20 protein on their surface. Originally developed for treating certain types of blood cancers, it is now also used off-label in treating multiple sclerosis by reducing inflammation and immune system activity that damages nerve cells. This medication belongs to the class of selective immunosuppressants and works by depleting B-cells, which play a role in the autoimmune response associated with multiple sclerosis.
Ocrelizumab
A humanized monoclonal antibody medication administered through intravenous infusion that specifically targets CD20-positive B cells in the treatment of multiple sclerosis. It is officially approved for both relapsing and primary progressive forms of multiple sclerosis, working by selectively depleting B cells that contribute to nerve damage in MS patients. This medication belongs to the selective immunosuppressant class and represents a newer generation of B-cell targeting therapy, designed to reduce inflammatory responses in the central nervous system.

Investigated diseases

Multiple Sclerosis - A chronic disease affecting the central nervous system (brain and spinal cord) where the immune system mistakenly attacks the protective covering of nerve fibers called myelin. The damage to myelin leads to communication problems between the brain and the rest of the body, causing various symptoms that can come and go. In the relapsing-remitting form, people experience distinct attacks of symptoms followed by periods of partial or complete recovery. The disease typically causes issues with vision, balance, muscle control, and other basic body functions. Over time, the disease may progress differently in each person, with some experiencing mild symptoms while others may have more significant changes in their daily activities.