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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    20
  • sponsor
    Hoffmann-La Roche
Updated on 20 September 2022
clinically isolated syndrome
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.

Details
Condition Multiple Sclerosis, Clinically Isolated Syndrome
Treatment Ocrelizumab
Clinical Study IdentifierNCT04998851
SponsorHoffmann-La Roche
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 term singleton infant (≥37 weeks gestation)
Infant is between 2-24 weeks of life
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

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
Any medical, obstetrical or psychiatric condition that, in the opinion of the Investigator, would compromise the woman's ability to participate in this study
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)
Any other medical condition or abnormality that, in the opinion of the investigator, could compromise the infant's ability to participate in this study
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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