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

Last updated: December 4, 2024
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

4

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

Ocrelizumab

Clinical Study ID

NCT04998851
MN42989
2021-000063-79
  • Ages 18-40
  • Female

Study 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 Criteria

Inclusion

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 related to the Mother:

  • 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

  • Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the LMP

Exclusion Criteria related to the Infant:

  • >24 weeks of life at the time of the mother's first dose of ocrelizumab

  • Any abnormality that may interfere with breastfeeding or milk absorption

  • Active infection (may be included once the infection resolves)

  • Infant has any other medical condition or abnormality that, in the opinion of the investigator, could compromise the infant's ability to participate in this study, including interference with the interpretation of study results

  • At least one documented brief resolved unexplained event (BRUE), as defined by the 2016 Guidelines of the American Academy of Pediatrics

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Ocrelizumab
Phase: 4
Study Start date:
September 16, 2021
Estimated Completion Date:
February 26, 2025

Connect with a study center

  • John Hunter Hospital; Cardiology

    Newcastle, New South Wales 2305
    Australia

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 1Z1
    Canada

    Site Not Available

  • Hopital Pierre Wertheimer - Hopital Neurologique

    Bron, 69677
    France

    Site Not Available

  • Hôpital de la Pitié Salpétrière

    Paris, 75013
    France

    Site Not Available

  • St. Josef Hospital GmbH

    Bochum, 44791
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • St. Josef Hospital; Zentralapotheke

    Troisdorf, 53842
    Germany

    Site Not Available

  • Fondazione Ptv Policlinico Tor Vergata

    Roma, Lazio 00133
    Italy

    Site Not Available

  • Hosp. Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • Neurocenter of Southern Switzerland

    Lugano, 6900
    Switzerland

    Site Not Available

  • Queen Mary University of London

    London, EC1M 6BQ
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94117
    United States

    Site Not Available

  • University Of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

    Owosso, Michigan 48867
    United States

    Site Not Available

  • NYU-Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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