A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Recruiting now
Conditions studied: Myasthenia Gravis
In brief
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.
Key facts
- Study ID
- NCT06298565
- Run by
- argenx
- People needed
- 680
- Starts
- 2024-11-04
- Expected to finish
- 2034-06-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center, — San Francisco, California, United States (enrolling)
- SFM Clinical Research, LLC — Boca Raton, Florida, United States (enrolling)
- University of Florida College of Medicine Jacksonville — Jacksonville Beach, Florida, United States (enrolling)
- Medsol Clinical Research Center Inc — Port Charlotte, Florida, United States (enrolling)
- BayCare Health System, Inc. St Anthony's Hospital — St. Petersburg, Florida, United States (enrolling)
- Prairie Education and Research Cooperative and HSHS Medical Group — O'Fallon, Illinois, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
- Norton Neuroscience Institute — Louisville, Kentucky, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Henry Ford Health System — Detroit, Michigan, United States (enrolling)
- Oregon Health and Science University — Portland, Oregon, United States (enrolling)
- University of Colorado Hospital — Portland, Oregon, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- National Neuromuscular Research Institute — Austin, Texas, United States (enrolling)
- BCN Research, LLC - Gamma Therapeutic Center — Greenfield, Wisconsin, United States (enrolling)
- Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III — Linz, Austria (enrolling)
- UZ Leuven (University Hospitals Leuven) — Leuven, Belgium (enrolling)
- Klinikum Altenburger Land GmbH — Altenburg, Germany (enrolling)
- St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum — Bochum, Germany (enrolling)
- Klinikum Christophsbad — Göppingen, Germany (enrolling)
- Georg-August-Universität Göttingen — Göttingen, Germany (enrolling)
- Klinikum Oberberg — Gummersbach, Germany (enrolling)
- Universitätsklinikum Jena — Jena, Germany (enrolling)
Full record on ClinicalTrials.gov
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