Multiple Sclerosis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

20

Study ID:

NCT04998851

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 10 Locations for this study

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University of California San Francisco
San Francisco California, 94117, United States
University Of Colorado
Aurora Colorado, 80045, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Brigham and Womens Hospital
Boston Massachusetts, 02115, United States
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso Michigan, 48867, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
St. Josef Hospital GmbH
Bochum , 44791, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden , 01307, Germany
Hosp. Clinico San Carlos
Madrid , 28040, Spain
Queen Mary University of London
London , EC1M , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

20

Study ID:

NCT04998851

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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