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

  • Autoimmune Disorder
  • Multiple Sclerosis (MS)
  • Clinically Isolated Syndrome (CIS)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • Aurora
  • Boston
  • Dresden
  • London
  • Owosso
  • Philadelphia
  • San Francisco
Trial Identifier:

NCT04998851 2021-000063-79 MN42989

  • Brigham and Womens Hospital

    75 Francis St02115BostonUnited States
  • Hospital of the University of Pennsylvania

    3400 Spruce St19104PhiladelphiaUnited States
  • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

    819 North Shiawassee St48867OwossoUnited States
  • Northwestern Memorial Hospital

    251 E Huron St60611-2987
  • Queen Mary University of London

    EC1M 6BQLondonUnited Kingdom
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden

    74 Fetscherstraße01307DresdenGermany
  • University of California San Francisco

    94158San FranciscoUnited States
  • University Of Colorado

    12505 E 16th Ave80045AuroraUnited States
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    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.

    Hoffmann-La Roche Sponsor
    Phase 4 Phase
    NCT04998851, MN42989, 2021-000063-79 Trial Identifier
    Ocrelizumab Treatments
    Multiple Sclerosis, Clinically Isolated Syndrome Condition
    Official Title

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

    Eligibility Criteria

    Female Gender
    ≥18 Years & ≤ 40 Years Age
    No 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

    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

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