Not recruiting

Study on the Safety and Effects of Ocrelizumab for Children and Adolescents with Relapsing-Remitting Multiple Sclerosis

Verified siteRegistered drugNo placebo

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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 a condition known as Relapsing-Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis characterized by periods of new or increasing symptoms followed by periods of partial or complete recovery. The study is testing a medication called Ocrelizumab, which is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein. The purpose of the study is to evaluate the safety and effects of Ocrelizumab in children and adolescents who have this condition.

Participants in the study will receive Ocrelizumab and will be monitored over a period of time to assess how their bodies process the medication and how it affects their immune system, particularly a type of white blood cell known as B-cells. The study will also look at the overall health and development of the participants, including growth and other developmental milestones. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Ocrelizumab against no treatment.

The study will involve regular check-ups and tests, including blood tests and MRI scans, to monitor the participants' health and the medication's effects. The study aims to provide valuable information on how Ocrelizumab can be used to treat Relapsing-Remitting Multiple Sclerosis in younger patients, potentially leading to better treatment options in the future. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of relapsing-remitting multiple sclerosis (RRMS) and ensuring the patient meets specific criteria such as body weight and vaccination history.
Step 2
Baseline measurements
Baseline measurements are taken, including the expanded disability status scale (EDSS) score, which ranges from 0 to 5.5. Additional tests may include blood tests and brain MRI scans to assess disease activity.
Step 3
Medication administration
The patient receives ocrelizumab through an intravenous infusion. The initial dose is 300 mg, administered as a solution for infusion. This is followed by a second 300 mg dose two weeks later.
Prior to each infusion, the patient is given diphenhydramine hydrochloride (50 mg tablet) and methylprednisolone (500 mg solution for injection/infusion) to reduce potential infusion-related reactions. Paracetamol (500 mg tablet) may also be administered orally to manage any discomfort.
Step 4
Follow-up assessments
Regular follow-up assessments are conducted to monitor the patient's response to the treatment. These include measuring the serum concentration of ocrelizumab and the levels of CD19+ B-cells in the blood.
Additional evaluations may include checking vital signs, clinical laboratory test results, and brain MRI scans to monitor any changes in the central nervous system.
Step 5
Long-term monitoring
The study involves long-term monitoring until the estimated end date in December 2029. This includes tracking the occurrence and severity of any adverse events, changes in developmental milestones, and levels of blood immunoglobulins.
The presence of antibodies against standard vaccines and any non-MS central nervous system pathology are also assessed during this period.

Who can join the trial?

6 criteria

The patient must weigh at least 25 kilograms. However, patients weighing 40 kilograms or more are not being enrolled anymore.
Children and adolescents must have received all recommended vaccinations for their age to protect against infectious diseases.
Female patients who can have children must agree to either not have heterosexual intercourse or use birth control methods that are very effective (less than 1% chance of failure per year) during the treatment and for at least 24 weeks after the last dose of the study medication. They must also follow any stricter local rules.
The patient must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) according to specific criteria set by experts in pediatric multiple sclerosis.
The patient's Expanded Disability Status Scale (EDSS) score, which measures disability, must be between 0 and 5.5 at the time of screening.
If the patient has been on a continuous treatment for multiple sclerosis for at least 6 months in the past year, there must be evidence that the disease is still active. This means the patient must have had at least one relapse or at least one new active lesion in the brain as seen on an MRI scan.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently taking medications that might affect the study results.
Patients who have had a recent infection or illness that could impact their participation.
Patients who have a history of allergic reactions to similar medications.
Patients who are unable to follow the study procedures or attend scheduled visits.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of substance abuse or addiction.
Patients who have received certain vaccines recently.
Patients who have a history of cancer or other serious diseases.

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Verified sites

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

Verified
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, Italy
Verified
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Verified
Ospedale Pediatrico Bambino Gesu'
Rome, Italy

Trial locations

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Investigated drugs

Ocrelizumab is a medication being studied for its safety, tolerability, and effects in children and adolescents with relapsing-remitting multiple sclerosis. It works by targeting and reducing certain immune cells called B-cells, which are involved in the disease process. The study aims to understand how the body processes the medication and how it affects the immune system in young patients.

What is already known about the treatment

Ocrelizumab – Ocrelizumab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently approved for use in adults with multiple sclerosis, and ongoing studies are evaluating its safety and effectiveness in children and adolescents with relapsing-remitting multiple sclerosis (RRMS). The medication works by targeting and depleting CD20-positive B cells, which are believed to play a role in the abnormal immune response seen in multiple sclerosis. Ocrelizumab is classified as a monoclonal antibody, specifically designed to modulate the immune system's activity.

Investigated diseases

Relapsing-Remitting Multiple Sclerosis (RRMS) – This is a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery, called remissions. During a relapse, individuals may experience symptoms such as fatigue, numbness, vision problems, or difficulty with coordination and balance. These symptoms can vary in severity and duration. The disease progresses with these alternating phases, and over time, some individuals may experience a gradual worsening of symptoms. The exact cause of RRMS is not fully understood, but it involves an immune-mediated process that damages the protective covering of nerve fibers in the central nervous system.