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

• Status: Recruiting
• Trial end date: 2023-11-08
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborators: Illingworth; LabCorp; PPD
• Treatments: Ocrelizumab

Criteria

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 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