Not recruiting

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

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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).
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

4 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Albert Schweitzer Ziekenhuis
Verified
Dordrecht, The Netherlands
Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Rituximab
Rituximab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials to determine its effectiveness compared to ocrelizumab for treating relapsing multiple sclerosis (MS). The main use of rituximab is to help manage symptoms in patients with relapsing MS. It works by targeting and reducing specific immune cells called B cells, which are involved in the immune response that damages the nervous system in MS. Rituximab is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.
Ocrelizumab
Ocrelizumab is also given through an intravenous infusion, directly into a vein. It is an established treatment for multiple sclerosis, particularly for relapsing forms of the disease, and is being compared to rituximab in clinical trials. Ocrelizumab helps manage MS by targeting and depleting B cells, which play a role in the immune system's attack on the nervous system. Like rituximab, ocrelizumab is a monoclonal antibody, specifically designed to interact with certain proteins in the body to reduce disease activity.

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.