Ocrelizumab in Breastmilk

University of California San Francisco (UCSF)

Status

Completed

Conditions

Multiple Sclerosis

Clinically Isolated Syndrome

Treatments

Drug: Ocrelizumab

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04387110

17-22422

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

Female

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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