Status:
COMPLETED
Ocrelizumab in Breastmilk
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Multiple Sclerosis
Clinically Isolated Syndrome
Eligibility:
FEMALE
18-64 years
Brief 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 collec...
Detailed 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 pl...
Eligibility Criteria
Inclusion
- 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
- Patients unable to provide informed consent.
- Patients unable or unwilling to provide breast milk samples for analysis.
Key Trial Info
Start Date :
August 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04387110
Start Date
August 7 2020
End Date
March 1 2022
Last Update
December 16 2022
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94158