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Study on Ofatumumab Levels in Breast Milk of Women with Relapsing Multiple Sclerosis

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What is this trial about?

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

This clinical trial focuses on women with relapsing forms of Multiple Sclerosis (MS), a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The study examines the use of ofatumumab, a medication known by the brand name Kesimpta, which is administered as a solution for injection. The purpose of the study is to measure the concentration of ofatumumab in the breast milk of women who are breastfeeding and have started or restarted treatment with this medication after giving birth.

Participants in the study will receive ofatumumab injections and provide breast milk samples at specific times to determine how much of the medication is present in the milk. The study will track the concentration of ofatumumab in breast milk over a period of 28 days after the second or any subsequent maintenance dose. Additionally, the study will monitor the health of both the mothers and their breastfed infants for up to 12 months after the mothers begin or resume treatment with ofatumumab.

The study aims to gather important information about the presence of ofatumumab in breast milk and its potential effects on breastfed infants. This information will help healthcare providers make informed decisions about the use of ofatumumab in breastfeeding women with relapsing forms of MS. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered, and it is conducted at multiple centers to ensure a comprehensive collection of data.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Provide written informed consent before any study assessments are performed.
Ensure eligibility by confirming a diagnosis of a relapsing form of multiple sclerosis, being at least 18 years old, postpartum, and planning to exclusively breastfeed.
Confirm the delivery of a term infant (at least 37 weeks gestation).
Plan to initiate or re-initiate treatment with ofatumumab between 2 to 24 weeks postpartum, independently of the decision to participate in the study.
Step 2
Treatment with ofatumumab
Receive ofatumumab as a 20 mg solution for injection, administered subcutaneously.
The treatment involves a maintenance dose schedule, with the second or any subsequent dose being crucial for study measurements.
Step 3
Breast milk sampling
Provide breast milk samples at specific time points: before the second (or any subsequent) maintenance dose, and then 7, 14, 21, and 28 days after this dose.
These samples are used to measure the concentration of ofatumumab in breast milk.
Step 4
Monitoring and follow-up
Monitor for any adverse events in both the mother and the breast-fed infant up to 12 months after the initiation or re-initiation of ofatumumab treatment.
Assess the maximum concentration of ofatumumab in breast milk and calculate the exposure over 28 days.
Evaluate the milk/plasma ratio and the estimated relative infant dose over the same period.

Who can join the trial?

5 criteria

You must provide written informed consent before any study activities begin. This means you agree to participate and understand what the study involves.
You need to be a female with a relapsing form of **Multiple Sclerosis (MS)**, which is a condition affecting the brain and spinal cord, and you must be at least 18 years old.
You should be **postpartum**, meaning you have recently given birth, and you plan to exclusively breastfeed your baby. You must also be willing to provide samples of your breast milk for the study.
You must have delivered a **term infant**, which means your baby was born after at least 37 weeks of pregnancy.
You should plan to start or have already started treatment with **ofatumumab**, a medication, between 2 to 24 weeks after giving birth. The decision to use ofatumumab and to breastfeed should be made with your doctor and should not be influenced by your participation in the study.

Who cannot join the trial?

10 criteria

Participants must not have any other serious health conditions that could interfere with the study.
Participants should not be taking any other medications that might affect the study results.
Participants must not have any allergies to the study medication or its ingredients.
Participants should not have any history of drug or alcohol abuse.
Participants must not be pregnant or planning to become pregnant during the study.
Participants should not have participated in another clinical trial recently.
Participants must not have any infections that could affect the study.
Participants should not have any conditions that affect their immune system.
Participants must not have any mental health conditions that could interfere with the study.
Participants should not have any history of cancer, except for certain types that have been treated successfully.

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Verified sites

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

Verified
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Turin, Italy
Verified
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia, Italy
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany

Trial locations

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Investigated drugs

Ofatumumab (Kesimpta®) is a medication used in the treatment of relapsing forms of multiple sclerosis (RMS). In this clinical trial, the focus is on measuring the concentration of ofatumumab in the breast milk of lactating women who have started or restarted treatment with this medication after giving birth. Ofatumumab works by targeting specific cells in the immune system to help reduce the frequency of relapses and slow the progression of the disease.

Ofatumumab

What is already known about the treatment

Ofatumumab – This medication is administered as an injection under the skin, typically used for treating relapsing forms of multiple sclerosis (RMS). It is currently being studied in clinical trials to understand its concentration in the breast milk of lactating women with RMS. Ofatumumab works by targeting and depleting specific immune cells known as B-cells, which are involved in the abnormal immune response seen in multiple sclerosis. It belongs to the pharmacological class of monoclonal antibodies, which are designed to specifically target and bind to certain proteins in the body.

Investigated diseases

Relapsing forms of Multiple Sclerosis (RMS) – This is a type of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During a relapse, individuals may experience symptoms such as fatigue, vision problems, muscle weakness, or difficulty with coordination and balance. These symptoms can vary in severity and duration. Between relapses, the disease may remain stable for some time, but it can also progress, leading to a gradual worsening of symptoms. RMS is the most common form of multiple sclerosis at the time of diagnosis. The exact cause of RMS is not fully understood, but it involves an abnormal immune response that damages the protective covering of nerve fibers in the central nervous system.