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

Contact details

Amy Miller

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Study protocol
Initial protocol
English (2.76 MB - PDF)View document
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)