A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.

Myasthenia Gravis Clinical Trial

Official title:

A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06299748
• Other study ID #: ARGX-113-PAC-2206
• Status: Not yet recruiting
• Start date: February 29, 2024
• Est. completion date: December 2033

Study information

• Verified date: March 2024
• Source: argenx
• Contact: Sabine Coppieters, MD
• Phone: 857-350-4834
• Email: Clinicaltrials[@]argenx.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 279
• Est. completion date: December 2033
• Est. primary completion date: December 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with exposure to efgartigimod any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod 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 informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written informed assent or eConsent by the pregnant minor (where applicable) and written informed consent or eConsent by the parent/legal guardian).

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Myasthenia Gravis

Intervention

Biological:
• Efgartigimod
Efgartigimod IV or SC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
argenx

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy outcomes	Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery)	up to 10 years
Secondary	Congenital malformations	Congenital malformations (CDC 2020b) identified in the developing fetus, neonate, or infant: Major congenital malformations (MCMs); Minor congenital malformations	up to 10 years
Secondary	The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness)	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	up to 10 years
Secondary	Maternal complications of pregnancy	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	up to 10 years
Secondary	Maternal infections		up to 10 years
Secondary	The number of observed fetal growth deficiency		up to 10 years