A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding

ARGX-113-PAC-2206

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported.

2024-02-29

2033-12-01

2033-12-01

Not yet recruiting

279

Inclusion Criteria: * Women with exposure to efgartigimod any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days. * Written informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written informed assent or eConsent by the pregnant minor (where applicable) and written informed consent or eConsent by the parent/legal guardian). Exclusion Criteria: * None

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Year', 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 279, 'type': 'ESTIMATED'}}

2024-03-08