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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT04998812

Public ClinicalTrials.gov record NCT04998812. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 4:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04998812
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
70 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 40 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 12, 2022
Primary completion
Apr 7, 2024
Completion
Jul 13, 2025
Last update posted
Apr 14, 2026

2022 – 2025

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
University of California San Francisco San Francisco California 94158
University Of Colorado Aurora Colorado 80045
The Ken and Ruth Davee department of Neurology Chicago Illinois 60611-4296
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04998812, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 14, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04998812 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →