Summary

Eligibility
for females ages 18-40 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Multiple Sclerosis Clinically Isolated Syndrome ocrelizumab, OCREVUS, breastmilk transfer, breast milk transfer, lactation Ocrelizumab

Eligibility

You can join if…

Open to females ages 18-40

  • 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

You CAN'T join if...

related to the Mother:

  • 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

Locations

  • University of California San Francisco
    San Francisco California 94117 United States
  • University of Alberta Hospital
    Edmonton Alberta T6G 1Z1 Canada

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04998851
Phase
Phase 4
Study Type
Interventional
Last Updated