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

argenx

Status: Enrolling

Conditions: Myasthenia Gravis

Treatments: Biological: efgartigimod

Study type: Observational

Funder types: Industry

Identifiers

NCT06298565

ARGX-113-PASS-2208

Details and patient eligibility

About

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.

Enrollment: 680 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

680 participants in 2 patient groups

efgartigimod cohort

Description:

patients treated with efgartigimod

Treatment:

Biological: efgartigimod

non-efgartigimod cohort

Description:

patient treated with other MG medication