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ACTIVE NOT RECRUITING
NCT06444113
PHASE4

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

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