Summary

Eligibility
for females ages 18-64 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
Riley Bove, MD, MSc
Photo of Riley Bove
Riley Bove

Description

Summary

The goal of the current project is to measure the levels of ocrelizumab in the breastmilk of 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.

Official Title

Monoclonal Antibodies in Mothers' Milk and Infants: Ocrelizumab in Breastmilk

Details

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 infusion 1 and after infusion 2 at 8H, 24H, 7D, 20D, 30D, 60D, and 90D in 20. Blood samples to determine serum concentration of ocrelizumab will be collected, when possible, at the 24-hour, 14 day (if receiving 300mg infusion x2), and 20D timepoint(s). Both women continuing to breastfeed their infant post-infusion and those that chose to discontinue will be included in the study.

In order to ensure broad collaboration as well as rapid recruitment, samples will be collected from patients fitting eligibility criteria upon referral to our study by other investigators.

Keywords

Multiple Sclerosis Clinically Isolated Syndrome Ocrelizumab

Eligibility

You can join if…

Open to females ages 18-64

  • 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.

You CAN'T join if...

  • Patients unable to provide informed consent.
  • Patients unable or unwilling to provide breast milk samples for analysis.

Location

  • University of California, San Francisco
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Riley Bove, MD, MSc
    Assistant Professor, Neurology. Authored (or co-authored) 89 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04387110
Study Type
Observational
Last Updated