Trial intelligence / Profile preview

Ocrelizumab in breastfeeding women with MS/CIS

NCT04998851Phase 4Completed

Sponsor
Roche
Start
Sep 2021
Primary completion
Mar 2024
Modality
Monoclonal Antibodies
Countries
3
01

Overview

Phase 4, open-label, single-arm trial of ocrelizumab in multiple sclerosis (MS) and clinically isolated syndrome (CIS), sponsored by Roche. Primary endpoints: Percentage of Infants With B Cell Levels (CD19+ Cells) Below the Lower Limit of Normal at 30 days and Estimated Average Oral Daily Infant Dosage at 60 days. Started Sep 2021; status: completed.

02

Drugs

ocrelizumab
03

Conditions

multiple sclerosis (MS)clinically isolated syndrome (CIS)

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