Tracks pregnancy and infant outcomes after efgartigimod use in myasthenia gravis and CIDP
Follows pregnant women and breastfeeding mothers who took efgartigimod for nerve or muscle disease.
Key facts
- Who runs it
- argenx
- Where
- Roma, ItalySee the siteAlso in 3 other countries, 3 sites
- Trial code
- Registry title
- A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
- Status
- Recruiting
- People taking part
- 279 people, planned
- Started
- 30 Nov 2023
- Expected to end
- Dec 2033
- Type of study
- Observational, 2 groups
- Treatments tested
- Efgartigimod
- Record updated
- 17 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women who took efgartigimod before or during pregnancy, or while breastfeeding. It follows the health of the mother, the pregnancy and the baby.
- Sex
- Women only.
- Earlier treatment
- Must have taken efgartigimod or efgartigimod PH20 SC within 25 days before conception, at any time during pregnancy, or during breastfeeding.
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC 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/verbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or eConsent by the pregnant minor (where applicable) and written/verbal informed consent or eConsent by the parent/legal guardian)
Who cannot take part
- None
Where in Italy
Also in 3 other countries, 3 sites
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyContact: Sabine Coppieters, MDTaking people
About the trial
What the trial wants to find out
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC 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 efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.
The 2 groups in the trial
- Retrospective Pregnancy
woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy
Treatment: Efgartigimod
- Prospective Pregnancy
woman is pregnant or breastfeeding at time of study enrollment.
Treatment: Efgartigimod
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding
- Plain-language title
- Tracks pregnancy and infant outcomes after efgartigimod use in myasthenia gravis and CIDPGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 February 2026