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Study on the Effects of Annual vs. Semi-Annual Ocrelizumab Infusions in Patients with Active Multiple Sclerosis After 2 Years of Initial Treatment

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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 the effects of a medication called Ocrevus on patients with multiple sclerosis (MS), a disease that affects the brain and spinal cord, leading to symptoms like fatigue, difficulty walking, and vision problems. The study is comparing two different treatment schedules: one group will receive Ocrevus infusions once a year, while the other group will receive them twice a year. The purpose of the study is to see if the less frequent treatment is as effective as the more frequent one in preventing new disease activity as seen on MRI scans, which are imaging tests that help doctors see inside the body.

Participants in the study will have already been treated with Ocrevus for at least two years. The study will last for two more years, during which time participants will continue to receive their assigned treatment schedule. Throughout the study, participants will undergo regular MRI scans to check for any new signs of disease activity. The study will also monitor for any relapses, which are periods when symptoms get worse, and any changes in disability levels, which refer to how much the disease affects daily activities.

In addition to monitoring disease activity, the study will also look at other health factors, such as changes in certain blood proteins and the occurrence of infections or other health issues. This information will help researchers understand the overall impact of the different treatment schedules on patients' health and well-being. The study aims to provide valuable insights into the best way to manage multiple sclerosis with Ocrevus treatment.

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
Joining the study
Upon joining the study, the patient will have already received information about the study and signed a consent form to participate. The patient must be at least 18 years old, have been treated with ocrelizumab for at least two years, and meet other specific criteria related to their health condition.
Step 2
Initial assessment
The patient will undergo an initial assessment, which includes a cerebral-medullary MRI to establish a baseline for the study. This MRI will help in comparing future results to determine the absence of new or enlarged lesions.
Step 3
Treatment administration
The patient will receive ocrelizumab through an IV infusion. The dosage is 300 mg, and the frequency of administration will be either annually or semi-annually, depending on the group to which the patient is assigned. This treatment will continue for the duration of the study.
Step 4
Ongoing monitoring
Throughout the study, the patient will have regular follow-up appointments. These appointments will include additional MRIs to monitor for any new or enlarged lesions and assess the effectiveness of the treatment. The patient will also be monitored for any relapses or progression in disability.
Step 5
Final assessment
At the end of the study period, which is 24 months from the initial assessment, the patient will undergo a final cerebral-medullary MRI and other evaluations to determine the overall effectiveness of the treatment plan. The results will be compared to the initial assessment to evaluate the absence of radiological disease activity.

Who can join the trial?

9 criteria

Patient must be 18 years or older.
Must have completed at least the 4th cycle of ocrelizumab treatment. Ocrelizumab is a medication used to treat multiple sclerosis (MS).
Requires a follow-up cerebral-medullary MRI as part of their care. An MRI is a type of scan that helps doctors see inside the body, especially the brain and spinal cord.
Had relapsing-remitting or secondarily progressive MS when starting anti-CD20 therapy (ocrelizumab or rituximab). This means they had either a pattern of MS with clear attacks or a form that started as relapsing-remitting and then became more steadily worsening.
No MS relapses for at least 18 months. A relapse is a period when symptoms get worse.
Has an EDSS score between 0 and 6 inclusive. EDSS is a scale used to measure the level of disability in people with MS, where 0 means no disability and 6 means needing a walking aid.
Has received information about the study and has signed a consent form to participate. This means they agree to join the study after understanding what it involves.
Must have knowledge of the French language.
Must be affiliated with or a beneficiary of a social security scheme. This means they have access to a health insurance system.

Who cannot join the trial?

3 criteria

Patients who have not been treated with ocrelizumab for at least 2 years cannot participate. Ocrelizumab is a medication used to treat multiple sclerosis.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fall within the eligible age group.
Patients who belong to a vulnerable population cannot participate. This typically includes groups like pregnant women, children, or those unable to give consent, but specifics should be confirmed.

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Verified sites

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

Verified
CHU Grenoble Alpes
La Tronche, France
Verified
Centre Hospitalier Et Universitaire De Limoges
Limoges, France
Responsive
Hospices Civils De Lyon
Lyon, France

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Investigated drugs

Ocrelizumab is a medication used in the treatment of multiple sclerosis (MS), a condition where the immune system mistakenly attacks the protective covering of nerves. This medication works by targeting and reducing certain cells in the immune system that are believed to play a role in the damage caused by MS. In this clinical trial, researchers are studying the effects of giving ocrelizumab once a year compared to the more traditional approach of giving it twice a year. The goal is to see if the less frequent dosing is just as effective in preventing new signs of disease activity in the brain, as seen on MRI scans, after two years of treatment.

Ocrelizumab

What is already known about the treatment

Ocrelizumab – Ocrelizumab is administered through an infusion, which means it is given directly into the bloodstream via a vein. It is currently used in medicine to treat multiple sclerosis, a condition where the immune system attacks the protective covering of nerves. The main therapeutic use of ocrelizumab is to reduce the frequency of relapses and slow the progression of disability in multiple sclerosis. At the molecular level, ocrelizumab works by targeting and depleting certain immune cells called B cells, which are believed to play a role in the disease. It is classified as a monoclonal antibody, a type of medication designed to specifically target and bind to certain 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 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. As the disease progresses, it can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of multiple sclerosis can be unpredictable, with periods of remission and relapses. Over time, some individuals may experience a steady progression of symptoms without periods of remission.