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 before enrolment during the screening period
Documentation that the last exposure to ocrelizumab occurred up to 6 months before the 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 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