Actively Recruiting
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding
Led by argenx · Updated on 2026-02-17
279
Participants Needed
4
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety of efgartigimod or efgartigimod PH20 SC exposure in pregnant women and breastfeeding mothers across multiple countries. It focuses on monitoring maternal, fetal, and infant outcomes related to these exposures, including rates of major congenital malformations. The study collects background data from similar populations for comparison. Participants include women who were exposed to efgartigimod or efgartigimod PH20 SC within 25 days before conception, during pregnancy, or exclusively during breastfeeding. Women who are no longer pregnant at enrollment but had prior exposure are included, as well as those currently pregnant or breastfeeding. During the study, researchers will observe pregnancy outcomes, congenital malformations, fetal growth issues, maternal complications and infections, and serious illnesses in newborns and infants. These outcomes will be tracked for up to 10 years, providing long-term safety data. Participants provide consent and are monitored through routine data collection without assigned treatments.
CONDITIONS
Brief Title
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days before conception or during pregnancy
- Women exposed to efgartigimod or efgartigimod PH20 SC during breastfeeding
- Able to provide written or verbal informed consent or eConsent
- For pregnant minors, assent or eConsent by participant and consent by parent or legal guardian
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 10 years
Participants are monitored for maternal, fetal, and infant outcomes following exposure to efgartigimod during pregnancy and/or breastfeeding.
Periodic visits depending on pregnancy and infant follow-up schedules
Trial Site Locations
Total: 4 locations
1
United BioSource LLC
Morgantown, West Virginia, United States, 26508
Actively Recruiting
2
Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1)
Bochum, Germany, 44791
Actively Recruiting
3
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
4
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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