A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Efgartigimod.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding
Overview
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.
Interventions
- Biological Efgartigimod
Efgartigimod IV or SC
Primary outcome measures
- Pregnancy outcomes [Time frame: up to 10 years]
Secondary outcome measures (5)
- Congenital malformations [Time frame: up to 10 years]
- The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness) [Time frame: up to 10 years]
- Maternal complications of pregnancy [Time frame: up to 10 years]
- Maternal infections [Time frame: up to 10 years]
- The number of observed fetal growth deficiency [Time frame: up to 10 years]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- United BioSource LLC — Morgantown
Germany · 1 center
- Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre In — Bochum
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Spain · 1 center
- Hospital Universitari Vall d'Hebron — Barcelona
Identifiers
NCT: NCT06299748 · ARGX-113-PAC-2206