RecruitingPhase 4NCT06444113

Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis

A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab


Sponsor

Novartis Pharmaceuticals

Enrollment

20 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study measures how much of a multiple sclerosis (MS) medication called ofatumumab (Kesimpta) passes into breast milk when nursing mothers take it. This helps researchers understand whether it is safe to breastfeed while on this treatment. **You may be eligible if...** - You are a woman with a relapsing form of MS - You are at least 18 years old and have recently given birth (at least 37 weeks gestation) - You are currently breastfeeding exclusively and plan to start or restart ofatumumab between 2 and 24 weeks after delivery - The decision to take ofatumumab and breastfeed was made independently with your doctor before joining the study **You may NOT be eligible if...** - You have had breast implants, augmentation, or reduction surgery - You have a history of alcohol or drug abuse in the past year - You have active hepatitis B, HIV, or a serious immune deficiency - You are pregnant - You have had a cancer diagnosis in the past 5 years - You received anti-CD20 therapy during the second or third trimester Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOfatunumab

No study-treatment is provided for this study. Study participants will be treated with commercially available ofatumumab according to the local label.


Locations(22)

Duke Neurology

Durham, North Carolina, United States

UC Health Neuroscience Ctr

Aurora, Colorado, United States

UCSF

San Francisco, California, United States

Northwestern Medicine Northwestern University

Winfield, Illinois, United States

Brigham and Womens Hospital

Brookline, Massachusetts, United States

Novartis Investigative Site

Bochum, Germany

Novartis Investigative Site

Tübingen, Germany

Novartis Investigative Site

Foggia, FG, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Torino, TO, Italy

Novartis Investigative Site

Bialystok, Poland

Novartis Investigative Site

Kielce, Poland

Novartis Investigative Site

Rzeszów, Poland

Novartis Investigative Site

Zabrze, Poland

Caribbean Center for Clinical Research, Inc

Guaynabo, Puerto Rico

Novartis Investigative Site

Krakow, Poland

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Salford, United Kingdom

Novartis Investigative Site

Oxford, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Cambridge, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06444113


Related Trials