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

Description

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.

Conditions

Myasthenia Gravis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Boca Raton

SFM Clinical Research, LLC, Boca Raton, Florida, United States, 33487

St. Petersburg

BayCare Health System, Inc. St Anthony's Hospital, St. Petersburg, Florida, United States, 33705

O'Fallon

Prairie Education and Research Cooperative and HSHS Medical Group, O'Fallon, Illinois, United States, 62701

Louisville

Norton Neuroscience Institute, Louisville, Kentucky, United States, 40241

Austin

National Neuromuscular Research Institute, Austin, Texas, United States, 78759

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * None

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

argenx,

Study Record Dates

2034-06