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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| efgartigimod cohort | patients treated with efgartigimod |
| |
| non-efgartigimod cohort | patient treated with other MG medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efgartigimod | Biological | efgartigimod |
|
| Measure | Description | 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 | up to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with gMG
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Coppieters, MD | Contact | 857-350-4834 | Clinicaltrials@argenx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center, | Recruiting | San Francisco | California | 94143 | United States |
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| SFM Clinical Research, LLC | Recruiting | Boca Raton | Florida | 33487 | United States |
|
| University of Florida College of Medicine Jacksonville | Recruiting | Jacksonville Beach | Florida | 32209 | United States |
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| Medsol Clinical Research Center Inc | Recruiting | Port Charlotte | Florida | 33952 | United States |
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| BayCare Health System, Inc. St Anthony's Hospital | Recruiting | St. Petersburg | Florida | 33705 | United States |
|
| Prairie Education and Research Cooperative and HSHS Medical Group | Recruiting | O'Fallon | Illinois | 62701 | United States |
|
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Norton Neuroscience Institute | Recruiting | Louisville | Kentucky | 40241 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
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| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Colorado Hospital | Recruiting | Portland | Oregon | 97239 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| National Neuromuscular Research Institute | Recruiting | Austin | Texas | 78759 | United States |
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| BCN Research, LLC - Gamma Therapeutic Center | Recruiting | Greenfield | Wisconsin | 53228 | United States |
|
| Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III | Recruiting | Linz | 4021 | Austria |
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| UZ Leuven (University Hospitals Leuven) | Recruiting | Leuven | 3000 | Belgium |
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| Klinikum Altenburger Land GmbH | Recruiting | Altenburg | 04600 | Germany |
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| St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum | Recruiting | Bochum | 44791 | Germany |
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| Klinikum Christophsbad | Recruiting | Göppingen | 7303 | Germany |
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| Georg-August-Universität Göttingen | Recruiting | Göttingen | 37073 | Germany |
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| Klinikum Oberberg | Recruiting | Gummersbach | 51643 | Germany |
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| Universitätsklinikum Jena | Recruiting | Jena | 07747 | Germany |
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| Universitätsklinikum Würzburg | Recruiting | Würzburg | 97080 | Germany |
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| Piazza OMS - Organizzazione Mondiale della Sanità | Recruiting | Bergamo | 24127 | Italy |
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| Ospedale Bellaria - Clinica Neurologica | Recruiting | Bologna | 40139 | Italy |
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| Azienda Ospedaliera di Rilievo Nazionale Cardarelli | Recruiting | Naples | 80131 | Italy |
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| Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | 56126 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitari de Bellvitge | Recruiting | Barcelona | 08907 | Spain |
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| Hospital Clinico Universitario San Carlos | Recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
|
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
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