Overview

A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This study will evaluate the potential placental transfer of ocrelizumab in women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.
Phase:
Phase 4
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborators:
Illingworth
LabCorp
PPD
Treatments:
Ocrelizumab