Monoclonal Antibodies in Mothers’ Milk and Infants: Ocrelizumab in Breastmilk
Sponsor:
Brief Summary:
women with multiple sclerosis (MS) and clinically isolated syndrome (CIS) who are postpartum,
and to collect information on 12-month infant development outcomes (length, weight, head
circumference, infections) in their offspring.
This study will fill a significant unmet need as many women with MS at high risk for
postpartum relapses are not effectively treated for their MS in the postpartum period due to
lack of information about the presence, concentration and effects of medications in
breastmilk.
Criteria
– Women between the ages of 18 and 64 that carry a diagnosis of Clinically Isolated
Syndrome or Multiple Sclerosis (based on the 2010 McDonald Criteria).
– Participants must be pregnant, contemplating pregnancy or postpartum at the time of
enrollment.
– Participants must be receiving treatment with ocrelizumab infusion between 2 and 36
weeks postpartum (300mg x2 or 600mg x1).
– Participants must be willing to provide breastmilk samples before and after their
first and, if applicable, second ocrelizumab infusions postpartum.
– A signed informed consent and HIPAA authorization form is required for participation.
Exclusion Criteria:
– Patients unable to provide informed consent.
– Patients unable or unwilling to provide breast milk samples for analysis.
Locations
- University of California, San Francisco, San Francisco, California, United States, 94158
