RecruitingObservational

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

NCT ID: NCT06298565Sponsor: argenxLast updated: 2026-02-17

Summary

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

Arms & interventions

Biologicalefgartigimod
efgartigimod

Outcome measures

Primary

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
Time frame: up to 10 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * 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 Criteria: * None

Study locations (17)

UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,

San Francisco, California, 94143

Recruiting

Min Kang, MD · Contact