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Retrospective Pregnancy for Myasthenia Gravis

N/A
Recruiting
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pregnancy outcomes
Secondary outcome measures
Congenital malformations
Maternal complications of pregnancy
Maternal infections
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Retrospective PregnancyExperimental Treatment1 Intervention
woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy
Group II: Prospective PregnancyExperimental Treatment1 Intervention
woman is pregnant or breastfeeding at time of study enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efgartigimod
2022
Completed Phase 2
~130

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Who is running the clinical trial?

argenxLead Sponsor
64 Previous Clinical Trials
9,917 Total Patients Enrolled
13 Trials studying Myasthenia Gravis
4,377 Patients Enrolled for Myasthenia Gravis
~186 spots leftby Dec 2033
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