CTIS2024-510974-25-00
Active, not recruiting
Phase 1
A Phase IV, Multicenter, Open-Label Study Evaluating B-Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy – The MINORE Study - MN42988
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- F. Hoffmann-La Roche AG
- Enrollment
- 29
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18\-40 years, inclusive, at screening., Have a 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 (12\-week) and second (18 to 20\-week) obstetric ultrasound (prenatal screening) has been conducted before enrolment, 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 (up to gestational week 13 inclusive)
Exclusion Criteria
- •Last exposure to ocrelizumab \>6 months before the woman’s LMP or later than the first trimester (i.e., after gestational week 13\), Gestational age at enrolment \>30 weeks, Non\-singleton pregnancy, Received last dose of ocrelizumab at a different posology other than per the local prescribing information, Social circumstances, that may preclude a woman from participating in the study, Additional exclusions related to obstetric and gynecological health, general health, laboratory findings, and medications
Outcomes
Primary Outcomes
Not specified
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