Study Comparing Rituximab and Ocrelizumab for Patients with Relapsing Multiple Sclerosis Starting Anti-CD20 Therapy

3 1 1 1

What is this study about?

This clinical trial is focused on studying the effectiveness of two medications, rituximab and ocrelizumab, in treating a condition known as relapsing multiple sclerosis (MS). Multiple sclerosis is a disease that affects the brain and spinal cord, leading to symptoms like fatigue, difficulty walking, and vision problems. The purpose of this study is to determine if rituximab is as effective as ocrelizumab for patients who need to start treatment with a type of medication called anti-CD20 therapy.

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 24 months, during which time participants will be monitored for any new or enlarged T2 lesions on their brain MRI scans. An MRI, or magnetic resonance imaging, is a type of scan that uses magnets and radio waves to create detailed images of the inside of the body. The study will also track the number of relapses, which are periods when symptoms of MS worsen, and the presence of contrast-enhancing lesions, which are areas of active inflammation in the brain.

Throughout the study, researchers will compare the results between the two groups to see if rituximab is not inferior to ocrelizumab in managing relapsing MS. This information will help doctors understand which medication might be more suitable for patients with this condition. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and your role. You will be required to provide signed informed consent, confirming your understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, diagnosis of relapsing multiple sclerosis (MS), and your ability to understand Dutch or English. Your Expanded Disability Status Scale (EDSS) score will also be checked to ensure it is 6.5 or lower.

3 treatment assignment

You will be randomly assigned to receive either rituximab or ocrelizumab. Both medications are administered as a solution for infusion, meaning they are given through a vein (intravenous).

4 medication administration

If assigned to rituximab, you may receive products such as Ruxience, Rixathon, MabThera, or Truxima. If assigned to ocrelizumab, you will receive Ocrevus. The dosage and frequency will be determined by the study protocol and your healthcare provider.

5 ongoing monitoring

Throughout the trial, regular monitoring will occur to assess your health and the effectiveness of the treatment. This includes periodic brain MRI scans to check for new or enlarged T2 lesions, as well as monitoring for any relapses or new symptoms.

6 final assessment

At the end of the trial period, a final assessment will be conducted. This will include a comprehensive evaluation of your condition and any changes that have occurred during the study.

Who Can Join the Study?

  • Men and women aged between 18 and 65 years.
  • A diagnosis of relapsing multiple sclerosis (MS), which is a type of MS where symptoms can come and go.
  • A recommendation from your neurologist to start treatment with anti-CD20 therapy, which is a type of medication used to treat MS.
  • Able to understand written and spoken Dutch or English.
  • Capable of giving signed informed consent, which means you understand the study and agree to participate.
  • A screening EDSS score of 6.5 or less. The EDSS is a scale used to measure disability in people with MS, with lower scores indicating less disability.

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, which means they might need special protection or care, cannot participate.
  • Patients who are not eligible for anti-CD20 therapy, which is a type of treatment targeting specific cells in the immune system, 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
Zuyderland Medisch Centrum Stichting Geleen The Netherlands

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Groene Hart Ziekenhuis Gouda The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Amphia Hospital Breda The Netherlands
Stichting Treant Ziekenhuiszorg Emmen The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Meander Medical Center Amersfoort The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Zaans Medisch Centrum Stichting Zaandam The Netherlands
St. Antonius Ziekenhuis Utrecht The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Flevoziekenhuis Stichting Almere The Netherlands
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
Uumlueqgcagw Msxtczz Ckekklr Gttgqrpki Groningen The Netherlands
Acbkdecnf Uhn Amsterdam The Netherlands
Eycujin Uudfpuigwhoi Mazbcmn Cqhxptc Rbkhkjryr (qkfxluz Mlh Rotterdam The Netherlands
Rvipryyow Zrrdlfbwcf Sjzrknhiv Arnhem The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.12.2022

Trial locations

Investigated drugs:

Rituximab is a medication used in this clinical trial to treat patients with relapsing multiple sclerosis (MS). It works by targeting specific cells in the immune system that are thought to play a role in the disease. By doing so, rituximab helps to reduce inflammation and prevent further damage to the nervous system, which can help manage symptoms and slow the progression of MS.

Ocrelizumab is another medication being studied in this trial for the treatment of relapsing multiple sclerosis. Like rituximab, it targets certain cells in the immune system to help control the disease. Ocrelizumab aims to reduce the frequency of relapses and slow down the progression of disability in people with MS by decreasing the activity of the immune system that attacks the nervous system.

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 can manifest in various forms, with relapsing-remitting multiple sclerosis being the most common, where symptoms flare up and then improve. Over time, some people may develop secondary-progressive multiple sclerosis, where symptoms steadily worsen. The progression of the disease can lead to physical and cognitive disabilities. Symptoms vary widely and can include fatigue, difficulty walking, numbness, and muscle weakness.

Trial ID:
2022-502664-21-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study to compare the effectiveness and safety of subcutaneous frexalimab versus intravenous frexalimab in adults with multiple sclerosis

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Spain
  • A study of RO7268489 added to ocrelizumab compared to placebo in adults with progressive multiple sclerosis

    Recruiting

    2 1 1
    Investigated drugs:
    France Germany Hungary Italy Poland Portugal +1