Ocrelizumab in Breastmilk

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · May 8, 2020

Keywords

ClinConnect Summary

Levels of ocrelizumab in breastmilk will be serially evaluated across one drug half-life from women with MS and CIS who are postpartum and lactating at the time of the infusion (whether or not they plan to continue to breastfeed their baby after the infusion). The timeline for breastmilk sample is dependent on infusion schedule and dosing if receiving 600mg infusion x1, collection will occur: before infusion and at 8H, 24H, 7D, 20D, 30D, 60D, and 90D post infusion; if receiving 300mg infusion x2 collection will occur: before infusion 1, at 8H, 24H, 7D, and 14D (before infusion 2) after infu...

Gender

FEMALE

Eligibility criteria

• Inclusion 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.