NCT04998812

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

A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Clinically Isolated Syndrome

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Post-partum dosing and treatment duration are at the discretion of the physicians, in accordance with local clinical practice and local labelling.

Timeline

• Start date: 2022-04-13
• Primary completion: 2024-04-08
• Completion: 2025-07-14
• First posted: 2021-08-10
• Last updated: 2026-04-15
• Results posted: 2025-05-22

Locations

11 sites across 5 countries: United States, France, Germany, Spain, Switzerland

Regulatory

• FDA-regulated drug study