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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2033-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myasthenia Gravis CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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

Efgartigimod

Intervention Type BIOLOGICAL

Efgartigimod IV or SC

Prospective Pregnancy

woman is pregnant or breastfeeding at time of study enrollment.

Efgartigimod

Intervention Type BIOLOGICAL

Efgartigimod IV or SC

Interventions

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Efgartigimod

Efgartigimod IV or SC

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).