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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

NCT04998812•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Diagnosis of MS or CIS (in line with the locally approved indications)
•Currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment
•Documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period
•Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy

Exclusion Criteria

•Last exposure to ocrelizumab \>6 months before the woman's LMP or later than the first trimester of pregnancy
•Gestational age at enrolment \>30 weeks
•Non-singleton pregnancy
•Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
•Lack of access to ultrasound pre-natal care as part of standard clinical practice
•Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
•Pre-pregnancy body mass index \>35 kg/m2
•Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
•Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
•Significant and uncontrolled disease that may preclude a woman from participating in the study
+9 more criteria

Locations (12)

University of California San Francisco

San Francisco, California, United States

University Of Colorado

Aurora, Colorado, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Hopital Pierre Wertheimer - Hopital Neurologique

Bron, France

Hôpital de la Pitié Salpétrière

Paris, France

St. Josef Hospital GmbH

Bochum, Germany

Universitaetsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

MultipEL Studies - Institut für klinische Studien

Hamburg, Germany

Hosp. Clinico San Carlos

Madrid, Spain

Key Dates

Start Date

April 13, 2022

Primary Completion Date

April 8, 2024

Completion Date

July 14, 2025

Last Updated

September 4, 2025

Enrollment

ACTUAL participants

Conditions

Multiple SclerosisClinically Isolated Syndrome

Interventions

Ocrelizumab

DRUG

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

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RECRUITINGNA

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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