At a glance
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A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
In Brief
A Phase 4 clinical trial evaluating Ocrelizumab for Multiple Sclerosis and Clinically Isolated Syndrome. Completed, enrolled 70 participants across 11 sites in 5 countries.
Detailed Summary
This study will evaluate the potential placental transfer of ocrelizumab in pregnant 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.
Study Details
Timeline
Interventions
Post-partum dosing and treatment duration are at the discretion of the physicians, in accordance with local clinical practice and local labelling.