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

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Resmedica Sp. z o.o.	Kielce	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Nupchu Sxd z ogmw	Rzeszow	Poland
Svpbnzfzolt Poagmhbsf Sdiyain Kbjglhrbe Nw 1 Iaipndatytfolzjgue Syiiprs Soziqyqar Uurpldoafrqi Mmsogefgwz W Kiwrypfyif	Zabrze	Poland
Aezbauu Oqcpcyizisz Ugawohihmjeyu Clqbzjdjthmr Diayo Sigmzh E Deife Souliqa Dr Thsczr	Turin	Italy
Aebrsao Oubfjfaccwc Uqidsjzpwaiwp Oilgusmu Rqxawme	Foggia	Italy
Ktjrmucd dzq Ulkqxuldcswe Mjjmxnwd Awu	Munich	Germany
Mzohiqmx Sfzvksg	Hamburg	Germany
Hpqbwzud Uwwhkfveyxufjr Slwaswybyx &fvupxa Helfzem dl Hvfmzylrguo	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	15.05.2024
Germany	Not recruiting	15.05.2024
Italy	Not recruiting	15.05.2024
Poland	Not recruiting	15.05.2024

Trial locations

Investigated drugs:

Ofatumumab

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.

Investigated diseases:

Multiple sclerosis relapse

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.

Trial ID:

2023-505283-11-00

Protocol code:

COMB157G2410

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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