Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Phase IV, Multicenter, Open-Label Study Evaluating B-Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy – The MINORE Study

This study, called MINORE, is for mothers with Multiple Sclerosis (MS) or a similar condition called Clinically Isolated Syndrome (CIS) who received the medicine Ocrevus during pregnancy. It aims to understand how Ocrevus might affect their babies. Researchers will check the baby's immune system, specifically certain white blood cells (B-cells), at six weeks old. They'll also measure the amount of Ocrevus in the baby's blood and cord blood, as well as the mother's blood. The study will track how well babies respond to their routine childhood vaccines and monitor both mothers' and babies' health, including any side effects. This helps gather valuable information for families and doctors.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

23 Apr 2024

Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]

What is this study about?

This study, called MINORE, is designed to understand what happens to babies whose mothers received a medicine called Ocrevus (also known as Ocrelizumab) for Multiple Sclerosis (MS) or a related condition during pregnancy. MS is a long-lasting condition that affects the brain and spinal cord. Ocrevus is a treatment that helps manage MS by targeting specific immune cells.

The main goal of this study is to look at babies' immune systems. Specifically, we want to see if a certain type of white blood cell, called B-cells, is at a normal level in the babies at six weeks old. B-cells are a very important part of our immune defenses, helping us fight off infections. We will also check how much Ocrevus is present in the baby after birth and in the mother's blood during and after pregnancy.

Beyond checking B-cells and medicine levels, the study will also look at how well babies respond to their routine childhood vaccinations. We'll be monitoring the overall health of both mothers and babies throughout the study, including any medical problems or side effects. This research is important because it will give doctors and parents more information about the effects of Ocrevus during pregnancy, helping them make the best choices for their health and their baby's health.

Key takeaways

The study investigates how Ocrevus taken during pregnancy affects babies.
It focuses on babies' immune cells (B-cells) and health.
Researchers will check Ocrevus levels in mothers and babies.
The study tracks babies' responses to routine childhood vaccinations.
It monitors the health of both mothers and babies.

Who may be eligible?

This study is looking for mothers who are at least 18 years old and have Multiple Sclerosis (MS) or a similar condition. This will include women who were treated with Ocrevus at some point during their pregnancy.

There are no upper age limits for participating. The study is open to all eligible mothers, regardless of where they are from or their background.

If you received Ocrevus during your pregnancy for MS or Clinically Isolated Syndrome and are now expecting or have recently given birth, you might be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS)?
Did you receive Ocrevus at any point during your current or recent pregnancy?
Are you pregnant or have you recently given birth?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be followed throughout your pregnancy and after your baby is born. We would take blood samples from you at different times during your pregnancy (around 24-30 weeks, 35 weeks), and just after delivery. When your baby is born, a sample of their umbilical cord blood would also be collected.

Your baby would have a check-up and a small blood sample taken at six weeks of age. We would also track how well your baby responds to their usual childhood vaccinations. Both you and your baby's health, including any medical events or hospital visits, would be monitored regularly until your baby is one year old. The total duration of your participation would be from when you join during pregnancy until your baby's first birthday.

Potential risks and benefits

Taking part in this study could help us learn more about how Ocrevus affects babies born to mothers with MS, which could benefit future families. The risks involve routine blood draws for both mother and baby, which can cause slight discomfort or bruising. Your baby will have a small blood sample taken. All medical procedures have some level of risk. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Germany

Common questions

What is MS?

MS stands for Multiple Sclerosis, a condition that affects your brain and spinal cord, which are parts of your nervous system.

What is Ocrevus?

Ocrevus is a medicine used to treat MS. It works by targeting specific cells in your immune system.

What are B-cells?

B-cells are a type of white blood cell that are an important part of your immune system, helping your body fight off infections.

Will my baby get extra medicines in this study?

No, this study does not involve giving your baby any extra medicines. They will receive their standard childhood vaccinations as usual.

How long will I be involved in the study?

You would be part of the study from your pregnancy until your baby turns one year old.