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

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What is this study about?

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.

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway
Nordlandssykehuset HF Bodo Norway
Karolinska University Hospital Solna Sweden
Sørlandet sykehus Kristiansand Kristiansand Norway
Vestre Viken HF Drammen Norway
Ssmvkbcty Taxfqguu Hv Skien Norway
Hjits Nenchdpqzrsbtn Hp Levanger Norway
Agnivthp Umbwyhmzql Hlpvkipl Lorenskog Norway
Hcqib Bhfqrr Hr Bergen Norway
Hmxfz Mkhxy Os Rygvegq Hm Aalesund Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not recruiting
02.11.2020
Sweden Sweden
Not recruiting
02.11.2020

Trial locations

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.

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.

Trial ID:
2024-510716-71-00
NCT ID:
NCT04578639
Trial Phase:
Therapeutic confirmatory (Phase III)

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