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

Purpose

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.

Condition

  • Myasthenia Gravis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
efgartigimod cohort patients treated with efgartigimod
  • Biological: efgartigimod
    efgartigimod
non-efgartigimod cohort patient treated with other MG medication

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Amanda Guidon, MD
857-350-4834
clinicaltrials@argenx.com

More Details

Status
Recruiting
Sponsor
argenx

Study Contact

Sabine Coppieters, MD
857-350-4834
Clinicaltrials@argenx.com