CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis
Conditions
Brief summary
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
BIOLOGICALEfgartigimod
Efgartigimod IV or SC
Sponsors
argenx
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy outcomes | up to 10 years | Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Congenital malformations | up to 10 years | Congenital malformations (CDC 2020b) identified in the developing fetus, neonate, or infant: Major congenital malformations (MCMs); Minor congenital malformations |
| The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness) | up to 10 years | Other events of interest identified in the developing neonate and infant (Hospitalizations for serious illness; Potential adverse reactions to medications; Growth and development milestones as described by the Centers for Disease Control and Prevention or other accepted standard assessments; Infant developmental deficiency; Postnatal growth deficiency or failure to thrive (FTT); Neonatal and infant mortality; Infections; Transient neonatal myasthenia; Vaccination and vaccine reactions |
| Maternal complications of pregnancy | up to 10 years | Maternal complications of pregnancy, including but not limited to: Premature rupture of membranes (PROM); Preterm PROM (PPROM); Pre-eclampsia; Gestational hypertension; Eclampsia; Proteinuria; Gestational diabetes; Intrauterine growth restriction (IUGR); Polyhdramnios |
| Maternal infections | up to 10 years | — |
| The number of observed fetal growth deficiency | up to 10 years | — |
Countries
Germany, Italy, Spain, United States
Contacts
CONTACTSabine Coppieters, MD
Outcome results
None listed