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Ocrelizumab in Breastmilk

NCT04387110 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-12-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ocrelizumab

Receiving either 1infusion (600mg) or 2 infusions (300mg).

Sponsors & Collaborators

Principal Investigators

  • Riley Bove, MD, MSc · University of California, San Francisco

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2022-03-01
Completion
2022-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04387110 on ClinicalTrials.gov