Observational Study of Efgartigimod Alfa for Myasthenia Gravis

This is an observational study looking at the long-term safety of efgartigimod alfa in people with generalized myasthenia gravis (gMG), a condition causing muscle weakness. The study will compare patients taking efgartigimod alfa to those not taking it. Researchers are especially interested in serious infections. You can join if you are 18 or older, have gMG, and are either starting efgartigimod alfa, are in your first cycle of treatment, or are not taking efgartigimod alfa. The study aims to follow participants for up to 10 years. The current status of this study is unclear.

Study design
This is an observational study with a planned enrollment of 680 participants. It compares patients taking efgartigimod alfa to those not taking it.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years to assess the long-term safety of efgartigimod alfa.

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NCT06298565

A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

Recruiting
Not specifiedAges 18+Observational
argenx
~680 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:efgartigimod

At a glance

Recruiting sites
35 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod
Measured over up to 10 years
Myasthenia Gravis
35 sites across 17 states
Germany7
Italy5
Florida4
Spain4
Massachusetts2
Oregon2
California1
Illinois1

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Eligibility criteria

Inclusion

Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment
Have provided appropriate written informed consent

Exclusion

None
  • The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimodup to 10 years