Enrolment of ~44 women between GWk 22–26, whose last OCR dose occurred at any time from 6 months before the LMP until the end of the first trimester
Primary endpoint: Proportion of infants with B-cell levels below LLN at Week 6 of life
Enrolment of at least 20 women who delivered a term infant and
made the decision to breastfeed whilst receiving OCR
(inclusion from 2–24 weeks post-partum)
Co-primary endpoints: Proportion of infants with B-cell levels below the LLN, measured 30 days after the mother’s first postpartum OCR infusion; Estimated ADID over 60 days after the mother’s first postpartum OCR infusion
More information is available at ClinicalTrials.gov
Do you have patients with MS receiving OCR who are pregnant? Please remember to report the pregnancy accordingly:
If you are in the United States, your patients may be able to take part in a global registry of women with MS who are pregnant and either have or have not received ocrelizumab during or within 6 months before their pregnancy. Click here for information
Outside the United States: Please report any occurrence of pregnancy in women receiving OCR here
*In utero exposure based on timing of last OCR dose relative to LMP. †Percentages represent fractions of the total known outcomes of the respective exposure category (not exposed in utero, exposed in utero, unknown exposure, total). ‡Percentages represent fractions of the total live births for the respective exposure category (not exposed in utero, exposed in utero, unknown exposure, total). §The dash indicated that no cases were reported.
ADID, average daily oral infant dose; CIS, clinically isolated syndrome; EUROCAT, European Surveillance of Congenital Anomalies; GWk, gestation week; LLN, lower limit of normal; LMP, last menstrual period; MCA, major congenital anomalies; OCR, ocrelizumab.
M-XX-00012408 (Date of preparation: February 2023)