Actively Recruiting
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Led by argenx · Updated on 2026-02-17
680
Participants Needed
35
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe the long-term safety of efgartigimod treatment in adults with generalized myasthenia gravis (gMG). It compares patients who are starting or have recently started efgartigimod treatment with those who have not been exposed to efgartigimod and are receiving other standard treatments. The study is non-interventional and prospective, focusing on real-world safety outcomes over an extended period. Participants are divided into two groups: one receiving efgartigimod and another receiving other medications for myasthenia gravis. This study does not involve any new treatments being administered as part of the trial but monitors patients during their routine care. The study will continue for up to 10 years to gather long-term safety data. During the study, researchers will track the occurrence of serious infections and other safety concerns in both groups. Patients will be monitored through their regular clinical visits without additional interventions from the study. Participants may be followed for up to 10 years to assess safety outcomes associated with their treatments in everyday medical practice.
CONDITIONS
Brief Title
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with generalized myasthenia gravis who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment
- Patients diagnosed with generalized myasthenia gravis 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 will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants who undergo routine care are observed to evaluate the long-term safety of efgartigimod, including the occurrence of serious infections, compared to patients treated with other myasthenia gravis medications.
Periodic visits based on routine healthcare
Trial Site Locations
Total: 35 locations
1
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,
San Francisco, California, United States, 94143
Actively Recruiting
2
SFM Clinical Research, LLC
Boca Raton, Florida, United States, 33487
Actively Recruiting
3
University of Florida College of Medicine Jacksonville
Jacksonville Beach, Florida, United States, 32209
Actively Recruiting
4
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States, 33952
Actively Recruiting
5
BayCare Health System, Inc. St Anthony's Hospital
St. Petersburg, Florida, United States, 33705
Actively Recruiting
6
Prairie Education and Research Cooperative and HSHS Medical Group
O'Fallon, Illinois, United States, 62701
Actively Recruiting
7
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
9
Norton Neuroscience Institute
Louisville, Kentucky, United States, 40241
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
13
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
14
University of Colorado Hospital
Portland, Oregon, United States, 97239
Actively Recruiting
15
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
16
National Neuromuscular Research Institute
Austin, Texas, United States, 78759
Actively Recruiting
17
BCN Research, LLC - Gamma Therapeutic Center
Greenfield, Wisconsin, United States, 53228
Actively Recruiting
18
Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III
Linz, Austria, 4021
Actively Recruiting
19
UZ Leuven (University Hospitals Leuven)
Leuven, Belgium, 3000
Actively Recruiting
20
Klinikum Altenburger Land GmbH
Altenburg, Germany, 04600
Actively Recruiting
21
St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum
Bochum, Germany, 44791
Actively Recruiting
22
Klinikum Christophsbad
Göppingen, Germany, 7303
Actively Recruiting
23
Georg-August-Universität Göttingen
Göttingen, Germany, 37073
Actively Recruiting
24
Klinikum Oberberg
Gummersbach, Germany, 51643
Actively Recruiting
25
Universitätsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
26
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Actively Recruiting
27
Piazza OMS - Organizzazione Mondiale della Sanità
Bergamo, Italy, 24127
Actively Recruiting
28
Ospedale Bellaria - Clinica Neurologica
Bologna, Italy, 40139
Actively Recruiting
29
Azienda Ospedaliera di Rilievo Nazionale Cardarelli
Naples, Italy, 80131
Actively Recruiting
30
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
31
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
32
Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia
Barcelona, Spain, 08035
Actively Recruiting
33
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
34
Hospital Clinico Universitario San Carlos
Madrid, Spain, 28040
Actively Recruiting
35
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here