A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
1 other identifier
observational
680
6 countries
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedStudy Start
First participant enrolled
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2034
February 17, 2026
February 1, 2026
9.6 years
March 1, 2024
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
up to 10 years
Study Arms (2)
efgartigimod cohort
patients treated with efgartigimod
non-efgartigimod cohort
patient treated with other MG medication
Interventions
Eligibility Criteria
Patients diagnosed with gMG
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- argenxlead
Study Sites (35)
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,
San Francisco, California, 94143, United States
SFM Clinical Research, LLC
Boca Raton, Florida, 33487, United States
University of Florida College of Medicine Jacksonville
Jacksonville Beach, Florida, 32209, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, 33952, United States
BayCare Health System, Inc. St Anthony's Hospital
St. Petersburg, Florida, 33705, United States
Prairie Education and Research Cooperative and HSHS Medical Group
O'Fallon, Illinois, 62701, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Norton Neuroscience Institute
Louisville, Kentucky, 40241, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Colorado Hospital
Portland, Oregon, 97239, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
National Neuromuscular Research Institute
Austin, Texas, 78759, United States
BCN Research, LLC - Gamma Therapeutic Center
Greenfield, Wisconsin, 53228, United States
Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III
Linz, 4021, Austria
UZ Leuven (University Hospitals Leuven)
Leuven, 3000, Belgium
Klinikum Altenburger Land GmbH
Altenburg, 04600, Germany
St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum
Bochum, 44791, Germany
Klinikum Christophsbad
Göppingen, 7303, Germany
Georg-August-Universität Göttingen
Göttingen, 37073, Germany
Klinikum Oberberg
Gummersbach, 51643, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Piazza OMS - Organizzazione Mondiale della Sanità
Bergamo, 24127, Italy
Ospedale Bellaria - Clinica Neurologica
Bologna, 40139, Italy
Azienda Ospedaliera di Rilievo Nazionale Cardarelli
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia
Barcelona, 08035, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital Clinico Universitario San Carlos
Madrid, 28040, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 7, 2024
Study Start
November 4, 2024
Primary Completion (Estimated)
June 1, 2034
Study Completion (Estimated)
June 1, 2034
Last Updated
February 17, 2026
Record last verified: 2026-02