Safety study of patients treated with efgartigimod for Myasthenia Gravis
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
This study is testing how safe the medication efgartigimod is for people with generalized Myasthenia Gravis who are just starting treatment or are in their first treatment cycle.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 680 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | argenx Industry-sponsored |
| Locations | 35 sites (San Francisco, California and 34 other locations) |
| Trial ID | NCT06298565 on ClinicalTrials.gov |
What this trial studies
This is a non-interventional, prospective safety study focusing on patients with generalized Myasthenia Gravis (gMG) who are either starting treatment with efgartigimod or are within their first treatment cycle. The study includes two cohorts: one for patients beginning efgartigimod and another for those who have not been exposed to the treatment. The aim is to monitor the safety and tolerability of efgartigimod in real-world settings. Participants will provide informed consent before enrollment.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with generalized Myasthenia Gravis who are starting or have recently started treatment with efgartigimod.
Not a fit: Patients who are not diagnosed with generalized Myasthenia Gravis or those who are not starting efgartigimod treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data that enhances the understanding of efgartigimod's effects in gMG patients.
How similar studies have performed: While this study is observational and focuses on safety, similar studies have shown success in monitoring treatment effects in other conditions, indicating a potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California and 34 other locations
- UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center, — San Francisco, California, United States (Recruiting)
- SFM Clinical Research, LLC — Boca Raton, Florida, United States (Recruiting)
- University of Florida College of Medicine Jacksonville — Jacksonville Beach, Florida, United States (Recruiting)
- Medsol Clinical Research Center Inc — Port Charlotte, Florida, United States (Recruiting)
- BayCare Health System, Inc. St Anthony's Hospital — St. Petersburg, Florida, United States (Recruiting)
- Prairie Education and Research Cooperative and HSHS Medical Group — O'Fallon, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Norton Neuroscience Institute — Louisville, Kentucky, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of Colorado Hospital — Portland, Oregon, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- National Neuromuscular Research Institute — Austin, Texas, United States (Recruiting)
- BCN Research, LLC - Gamma Therapeutic Center — Greenfield, Wisconsin, United States (Recruiting)
- Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III — Linz, Austria (Recruiting)
- UZ Leuven (University Hospitals Leuven) — Leuven, Belgium (Recruiting)
- Klinikum Altenburger Land GmbH — Altenburg, Germany (Recruiting)
- St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum — Bochum, Germany (Recruiting)
- Klinikum Christophsbad — Göppingen, Germany (Recruiting)
- Georg-August-Universität Göttingen — Göttingen, Germany (Recruiting)
- Klinikum Oberberg — Gummersbach, Germany (Recruiting)
- Universitätsklinikum Jena — Jena, Germany (Recruiting)
- Universitätsklinikum Würzburg — Würzburg, Germany (Recruiting)
- Piazza OMS - Organizzazione Mondiale della Sanità — Bergamo, Italy (Recruiting)
- Ospedale Bellaria - Clinica Neurologica — Bologna, Italy (Recruiting)
- Azienda Ospedaliera di Rilievo Nazionale Cardarelli — Naples, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
- Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia — Barcelona, Spain (Recruiting)
- Hospital Universitari de Bellvitge — Barcelona, Spain (Recruiting)
- Hospital Clinico Universitario San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario Virgen Macarena — Seville, Spain (Recruiting)
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: Clinicaltrials@argenx.com
- Phone: 857-350-4834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.