A Phase IV, Multicenter, Open-Label Study Evaluating B-Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy – The MINORE Study

Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]

1. Proportion of infants with B-cell levels (CD19+ cells, absolute counts) below the lower limit of normal (LLN), measured at week 6 of life

1. B-cell levels (CD19+ cells, absolute counts and percentage of lymphocytes) measured at week 6 of life, 2. Serum concentration of ocrelizumab in the umbilical cord blood at birth, 3. Serum concentration of ocrelizumab in the infant at week 6 of life, 4. Mean titers of antibody immune response(s) to vaccination to common childhood vaccinations with full or partial doses given prior to 1 year, which include responses to diphtheria, tetanus, pertussis, Hib, PCV-13, MMR, and HBV, 5. Proportion of infants with positive humoral response (seroprotective titers; as defined for the individual vaccine) to vaccines, 6. Serum concentration of ocrelizumab in the mother during pregnancy (time frame of blood sampling: Week 24-30, Week 35) and at delivery (time frame of blood sampling: within 24 hours after delivery), 7. Rate and nature of adverse events (AEs) in the mother throughout the study, including changes in clinical and laboratory results, 8.Rate and nature of AEs in the infant throughout the study, including infections and hospitalizations, 9. Proportion of pregnancies resulting in live births (term and preterm, with and without congenital anomalies), therapeutic abortions, or stillbirths, 10. Infant characteristics at birth, including but not limited to body weight, head circumference and length

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