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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate the potential placental transfer of ocrelizumab in women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborators: Illingworth; LabCorp; PPD
• Treatments: Ocrelizumab

Criteria

Inclusion Criteria:

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

• Currently pregnant with singleton pregnancy at gestational week ≤26 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 >26 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 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