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
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Written informed consent must be obtained before any study assessment is performed.
• Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
• Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples.
• Participant has delivered term infant (at least 37 weeks gestation).
• Participant must plan to initiate or re-initiate or have initiated or re-initiated treatment with ofatumumab between 2 to 24 weeks postpartum. The decision to be treated with ofatumumab and to breastfeed is made in accordance with the treating physician and must be completely independent of the decision to participate in this study.
Locations
United States
California
UCSF
ACTIVE_NOT_RECRUITING
San Francisco
Colorado
UC Health Neuroscience Ctr
ACTIVE_NOT_RECRUITING
Aurora
Illinois
Northwestern Medicine Northwestern University
ACTIVE_NOT_RECRUITING
Winfield
Massachusetts
Brigham and Womens Hospital
ACTIVE_NOT_RECRUITING
Brookline
North Carolina
Duke Neurology
RECRUITING
Durham
Other Locations
Germany
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bochum
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Munich
Novartis Investigative Site
RECRUITING
Tübingen
Italy
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Foggia
Novartis Investigative Site
WITHDRAWN
Roma
Novartis Investigative Site
WITHDRAWN
Torino
Poland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bialystok
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kielce
Novartis Investigative Site
RECRUITING
Krakow
Novartis Investigative Site
RECRUITING
Rzeszów
Novartis Investigative Site
RECRUITING
Zabrze
Puerto Rico
Caribbean Center for Clinical Research, Inc
RECRUITING
Guaynabo
United Kingdom
Novartis Investigative Site
RECRUITING
Cambridge
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
London
Novartis Investigative Site
RECRUITING
Oxford
Novartis Investigative Site
RECRUITING
Salford
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date:2024-11-25
Estimated Completion Date:2027-02-23
Participants
Target number of participants:20
Treatments
Experimental: Ofatunumab
Recommended dose as per ofatumumab label. Injection at weeks 0,1,2 and monthly starting at week 4.