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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000005
• 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: 31/12/2033

Study protocol

Initial protocol

ARGX-113-PAC-2206-EU Protocol v2.0_Redacted

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)