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

February 13, 2026 updated by: argenx
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

680

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Recruiting
        • Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III
        • Contact:
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven (University Hospitals Leuven)
        • Contact:
  • Germany
      • Altenburg, Germany, 04600
        • Recruiting
        • Klinikum Altenburger Land GmbH
        • Contact:
      • Bochum, Germany, 44791
        • Recruiting
        • St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum
        • Contact:
      • Gummersbach, Germany, 51643
      • Göppingen, Germany, 7303
        • Recruiting
        • Klinikum Christophsbad
        • Contact:
      • Göttingen, Germany, 37073
        • Recruiting
        • Georg-August-Universität Göttingen
        • Contact:
      • Jena, Germany, 07747
        • Recruiting
        • Universitätsklinikum Jena
        • Contact:
      • Würzburg, Germany, 97080
        • Recruiting
        • Universitatsklinikum Wurzburg
        • Contact:
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • Piazza OMS - Organizzazione Mondiale della Sanità
        • Contact:
      • Bologna, Italy, 40139
        • Recruiting
        • Ospedale Bellaria - Clinica Neurologica
        • Contact:
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera di Rilievo Nazionale Cardarelli
        • Contact:
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico Universitario San Carlos
        • Contact:
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Recruiting
        • SFM Clinical Research, LLC
        • Contact:
      • Jacksonville Beach, Florida, United States, 32209
        • Recruiting
        • University of Florida College of Medicine Jacksonville
        • Contact:
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Medsol Clinical Research Center Inc
        • Contact:
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • BayCare Health System, Inc. St Anthony's Hospital
        • Contact:
    • Illinois
      • O'Fallon, Illinois, United States, 62701
        • Recruiting
        • Prairie Education and Research Cooperative and HSHS Medical Group
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Norton Neuroscience Institute
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • University of Colorado Hospital
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • National Neuromuscular Research Institute
        • Contact:
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Recruiting
        • BCN Research, LLC - Gamma Therapeutic Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with gMG

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
efgartigimod cohort
patients treated with efgartigimod
Biological: efgartigimod
efgartigimod
non-efgartigimod cohort
patient treated with other MG medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Estimated)

June 1, 2034

Study Completion (Estimated)

June 1, 2034

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-PASS-2208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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