A Worldwide Pregnancy Safety Study to Assess Maternal, Foetal, and Infant Outcomes Following Exposure to Efgartigimod alfa during Pregnancy and/or Breastfeeding

Study identification

• EU PAS number:
  EUPAS1000000005
• Study ID:
  1000000005
• Official title and acronym:
  A Worldwide Pregnancy Safety Study to Assess Maternal, Foetal, and Infant Outcomes Following Exposure to Efgartigimod alfa during Pregnancy and/or Breastfeeding
• DARWIN EU® study:
  No
• Study countries:
  European Union

  United States
• Study description:
  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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Actual:03/01/2023

Study start date

Actual:14/12/2023

Date of final study report

Planned:01/06/2034

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)