Phase
Condition
Multiple Sclerosis
Memory Loss
Neurologic Disorders
Treatment
Ocrelizumab
Clinical Study ID
Ages 18-40 Female
Study Summary
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
Connect with a study center
John Hunter Hospital; Cardiology
Newcastle, New South Wales 2305
AustraliaSite Not Available
University of Alberta Hospital
Edmonton, Alberta T6G 1Z1
CanadaSite Not Available
Hopital Pierre Wertheimer - Hopital Neurologique
Bron, 69677
FranceSite Not Available
Hôpital de la Pitié Salpétrière
Paris, 75013
FranceSite Not Available
St. Josef Hospital GmbH
Bochum, 44791
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307
GermanyActive - Recruiting
St. Josef Hospital; Zentralapotheke
Troisdorf, 53842
GermanySite Not Available
Fondazione Ptv Policlinico Tor Vergata
Roma, Lazio 00133
ItalySite Not Available
Hosp. Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Universitätsspital Basel
Basel, 4031
SwitzerlandSite Not Available
Neurocenter of Southern Switzerland
Lugano, 6900
SwitzerlandSite Not Available
Queen Mary University of London
London, EC1M 6BQ
United KingdomSite Not Available
Salford Royal NHS Foundation Trust
Salford, M6 8HD
United KingdomSite Not Available
University of California San Francisco
San Francisco, California 94117
United StatesSite Not Available
University Of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Brigham and Womens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso, Michigan 48867
United StatesSite Not Available
NYU-Langone Medical Center
New York, New York 10016
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
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