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Study on B-Cell Levels in Infants Exposed to Ocrelizumab During Pregnancy for Mothers with Multiple Sclerosis or Clinically Isolated Syndrome

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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 the medication Ocrelizumab, known by its code name RO4964913, on infants who may have been exposed to it during pregnancy. The study is particularly interested in mothers with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS), which are conditions that affect the brain and spinal cord. Ocrelizumab is a treatment that is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate whether infants exposed to Ocrelizumab during pregnancy show any changes in their B-cell levels after birth. B-cells are a type of white blood cell that plays a crucial role in the immune system by helping the body fight infections. The study will monitor the infants' B-cell levels at six weeks of age to see if they are lower than normal. Additionally, the study will measure the amount of Ocrelizumab in the infants' blood and in the umbilical cord at birth, as well as in the mothers' blood during pregnancy and at delivery.

Throughout the study, researchers will also observe the infants' responses to common childhood vaccinations and monitor for any side effects or health issues in both the mothers and infants. The study aims to gather information on the health and development of the infants, including their weight, head size, and length at birth, as well as the outcomes of the pregnancies, such as live births or any complications. This information will help understand the potential impact of Ocrelizumab exposure during pregnancy on infant health.

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
Enrollment
Eligibility is determined based on age, diagnosis of multiple sclerosis (MS) or clinically isolated syndrome (CIS), pregnancy status, and previous exposure to ocrelizumab.
Pregnancy must be a singleton and at or before the 30th week of gestation at the time of enrollment.
Documentation of first and second obstetric ultrasounds is required before enrollment.
Step 2
Pregnancy monitoring
Blood samples are collected from the mother during pregnancy at weeks 24-30 and week 35 to measure the serum concentration of ocrelizumab.
Additional blood sampling occurs within 24 hours after delivery.
Step 3
Birth and initial infant assessment
At birth, the serum concentration of ocrelizumab is measured in the umbilical cord blood.
Infant characteristics such as body weight, head circumference, and length are recorded.
Step 4
Infant follow-up at week 6
B-cell levels in the infant are measured to determine if they are below the lower limit of normal.
The serum concentration of ocrelizumab in the infant is also measured.
The infant's response to common childhood vaccinations is assessed, including responses to vaccines for diphtheria, tetanus, pertussis, and others.
Step 5
Monitoring of adverse events
Throughout the study, any adverse events in both the mother and infant are monitored, including infections and hospitalizations.
The study also tracks the outcomes of pregnancies, such as live births, congenital anomalies, and other outcomes.

Who can join the trial?

5 criteria

Be between 18 and 40 years old at the time of screening.
Have a diagnosis of Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS). These are conditions that affect the brain and spinal cord.
Currently be pregnant with a single baby and be at or before the 30th week of pregnancy when joining the study.
Have proof that the first and second pregnancy ultrasounds have been done before joining the study. An ultrasound is a scan that uses sound waves to create images of the baby in the womb.
Have proof that the last exposure to ocrelizumab (a medication) happened up to 6 months before the last menstrual period before becoming pregnant, or during the first trimester of pregnancy (up to the 13th week of pregnancy).

Who cannot join the trial?

4 criteria

Individuals who do not have **Multiple Sclerosis (MS)** or **Clinically Isolated Syndrome (CIS)**. MS is a condition that affects the brain and spinal cord, while CIS is a first episode of symptoms that suggest MS.
Individuals who are not within the specified age range for the study.
Individuals who do not meet the gender requirements for the study.
Individuals who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Verified
Hospital Clinico San Carlos
Madrid, Spain
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany

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Investigated drugs

Ocrelizumab is a medication used in this clinical trial. It is a type of drug known as a monoclonal antibody, which targets specific cells in the immune system. In this study, the focus is on infants who may have been exposed to ocrelizumab during pregnancy. The trial aims to understand if this exposure affects the levels of B-cells, a type of white blood cell, in these infants after birth.

Ocrelizumab

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 the treatment of Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS) in various regions. 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 MS. Ocrelizumab is classified as a monoclonal antibody and is part of the immunomodulatory drug class.

Investigated diseases

Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by damage to the protective covering of nerve fibers, known as myelin, which disrupts communication between the brain and the rest of the body. Symptoms can vary widely and may include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The disease often progresses with periods of relapses and remissions, where symptoms may improve or worsen over time. The exact cause of MS is unknown, but it is believed to involve an abnormal immune response.
Clinically Isolated Syndrome
Clinically Isolated Syndrome (CIS) is a neurological episode that lasts at least 24 hours and is caused by inflammation or demyelination in the central nervous system. It is often considered a precursor to Multiple Sclerosis, as it involves similar symptoms such as vision problems, muscle weakness, and sensory disturbances. CIS can be a single event or may lead to further neurological episodes, potentially progressing to MS. The progression from CIS to MS depends on various factors, including the presence of specific markers in the brain. Early intervention and monitoring are crucial to understanding the potential development of MS from CIS.