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Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
Sponsor: Novartis Pharmaceuticals
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-11-25
Completion Date
2026-10-29
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Ofatunumab
No study-treatment is provided for this study. Study participants will be treated with commercially available ofatumumab according to the local label.
Locations (15)
UCSF
San Francisco, California, United States
UC Health Neuroscience Ctr
Aurora, Colorado, United States
Northwestern Medicine Northwestern University
Winfield, Illinois, United States
Brigham and Womens Hospital
Brookline, Massachusetts, United States
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Tübingen, Germany
Novartis Investigative Site
Foggia, FG, Italy
Novartis Investigative Site
Bialystok, Poland
Novartis Investigative Site
Kielce, Poland
Novartis Investigative Site
Cambridge, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Oxford, United Kingdom
Novartis Investigative Site
Salford, United Kingdom