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

Korábbi kezelés

• Last exposure to ocrelizumab >6 months before the woman's LMP or later than the first trimester of pregnancy
• Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
• Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
• 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
• Prior or current history of alcohol or drug abuse, or current use of tobacco
• 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

Más betegség

• 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
• Positive screening tests for hepatitis B

Életkor

• Gestational age at enrolment >30 weeks

Egyéb

• Non-singleton pregnancy
• Lack of access to ultrasound pre-natal care as part of standard clinical practice
• Pre-pregnancy body mass index >35 kg/m2

• 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