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

Inclusion Criteria:

• Diagnosis of MS or CIS (in line with the locally approved indications)

• Currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment

• Documentation that first and second obstetric ultrasound has been conducted beforeenrolment during the screening period

• Documentation that the last exposure to ocrelizumab occurred up to 6 months beforethe LMP before the woman became pregnant OR during the first trimester of pregnancy

Exclusion Criteria:

• Last exposure to ocrelizumab >6 months before the woman's LMP or later than thefirst 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 thelocal prescribing information

• Lack of access to ultrasound pre-natal care as part of standard clinical practice

• Prior or current obstetric/gynecological conditions associated with adversepregnancy outcomes

• Pre-pregnancy body mass index >35 kg/m2

• Any concomitant disease that may require chronic treatment with systemiccorticosteroids or immunosuppressants during the course of the study

• Prior or current history of primary or secondary immunodeficiency, or woman in anotherwise severely immunocompromised state

• Significant and uncontrolled disease that may preclude a woman from participating inthe study

• Women with known active malignancies or being actively monitored for recurrence ofmalignancy 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 asa bridging therapy after the last ocrelizumab dose and throughout pregnancy

• Treatment with disease-modifying therapies for MS within their respective half-livesprior 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 plasmaconcentrations are <0.02 mg/L. If levels are >0.02 mg/L or not known, an acceleratedelimination procedure is required

• Treatment with any investigational agent within 6 months or five half-lives of theinvestigational drug prior to the last ocrelizumab dose or prior to the LMP