A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

Exclusion Criteria

• •Last exposure to ocrelizumab \>6 months before the woman's LMP or later than the first trimester of pregnancy
• •Gestational age at enrolment \>30 weeks
• •Non-singleton pregnancy
• •Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
• •Lack of access to ultrasound pre-natal care as part of standard clinical practice
• •Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
• •Pre-pregnancy body mass index \>35 kg/m2
• •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• •Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
• •Significant and uncontrolled disease that may preclude a woman from participating in the study
• •Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies
• •Prior or current history of alcohol or drug abuse, or current use of tobacco
• •Positive screening tests for hepatitis B
• •Treatment with drugs known to have teratogenic effects
• •Planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose and throughout pregnancy
• •Treatment with disease-modifying therapies for MS within their respective half-lives prior to the last ocrelizumab dose or prior to the LMP
• •Treatment with natalizumab within 12 weeks prior to the LMP
• •Treatment with teriflunomide within the last two years, unless measured plasma concentrations are \<0.02 mg/L. If levels are \>0.02 mg/L or not known, an accelerated elimination procedure is required
• •Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the last ocrelizumab dose or prior to the LMP