Loading clinical trials...

A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

NCT04998851•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) \[in line with the locally approved indications\] treated with ocrelizumab, by assessing the concentration of ocrelizumab in mature breastmilk, as well as the corresponding exposure and pharmacodynamic effects (blood B cell levels) in the infants.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Woman is between 18 and 40 years of age at screening
•Woman is willing to breastfeed for at least 60 days after the first post-partum ocrelizumab infusion (this decision is to be taken prior to and independent from study participation)
•Woman is willing to provide breastmilk samples
•Woman has a diagnosis of MS or CIS (in line with the locally approved indications)
•Woman has delivered a healthy term singleton infant (≥37 weeks gestation)
•Infant is between 2-24 weeks of age at the time of the mother's first post-partum dose of ocrelizumab
•For women who received commercial ocrelizumab (OCREVUS) before enrolment: documentation that last exposure to ocrelizumab occurred more than 3 months before the last menstrual period (LMP) and was given at the approved dose of 2 x 300 mg or 1 x 600 mg
•Woman agrees to use acceptable contraceptive methods during the study

Exclusion Criteria

•Hypersensitivity to ocrelizumab or to any of its excipients
•Received last dose of ocrelizumab \<3 months before the LMP or during pregnancy
•Active infections (may be included once the infection is treated and is resolved; women with bilateral mastitis infection should not have samples collected until the infection is completely resolved)
•Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
•Known active malignancies, or being actively monitored for recurrence of malignancy
•History of breast implants, breast augmentation, breast reduction surgery or mastectomy
•Prior or current history of chronic alcohol abuse or drug abuse
•Positive screening tests for hepatitis B
•Treatment with a DMT for CIS or MS during pregnancy and/or first weeks post-partum, with the exception of formulations of interferon-beta, glatiramer acetate or pulsed corticosteroids
•Treatment with drugs known to transfer to the breastmilk and with established or potential deleterious effects for the infant
+6 more criteria

Locations (8)

University of California San Francisco

San Francisco, California, United States

University Of Colorado

Aurora, Colorado, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

Owosso, Michigan, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Hosp. Clinico San Carlos

Madrid, Spain

Queen Mary University of London

London, United Kingdom

Key Dates

Start Date

September 16, 2021

Primary Completion Date

March 29, 2024

Completion Date

January 13, 2025

Last Updated

January 14, 2026

Enrollment

ACTUAL participants

Conditions

Multiple SclerosisClinically Isolated Syndrome

Interventions

Ocrelizumab

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

RECRUITINGPHASE3

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

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

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: January 14, 2026Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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

Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study