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The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod PH20 SC | Experimental | Participants receiving efgartigimod PH20 SC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod PH20 SC | Biological | Subcutaneous injection of efgartigimod PH20 SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve MSE of MG at any time within the first 16 weeks of treatment with efgartigimod PH20 SC | MSE (minimal symptom expression) is defined as an MG-ADL (Myasthenia Gravis Activities of Daily Living) total score of 0 or 1. The MG-ADL scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe). | up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in MG-ADL total scores over time | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe). | up to 51 weeks |
| Changes from baseline in MG-QOL-15r total scores over time |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI) | Recruiting | La Jolla | California | 92037 | United States |
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The MG-QoL15r (Myasthenia Gravis Quality of Life 15-item scale revised) questionnaire is a patient-reported instrument that measures the impact of MG symptoms on Quality of Life. The score varies between 0 and 30 (with 30 the lowest quality of life). |
| up to 51 weeks |
| Proportion of participants who are administered systemic corticosteroid therapy as background add-on therapy throughout the study | up to 55 weeks |
| Incidence of adverse events, serious adverse events and adverse events leading to study drug discontinuation | up to 55 weeks |
| Samir Macwan, M.D., Inc. (S corporation) | Recruiting | Rancho Mirage | California | 92270 | United States |
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| EZR Research | Recruiting | Boca Raton | Florida | 33486 | United States |
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| University of Florida Jacksonville | Recruiting | Jacksonville | Florida | 32209 | United States |
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| Visionary Investigators Network | Recruiting | Miami | Florida | 33133 | United States |
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| University of California Irvine | Recruiting | Orange | Florida | 92868 | United States |
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| Medsol Clinical Research Center Inc | Recruiting | Port Charlotte | Florida | 33952 | United States |
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| Baycare Medical Group | Recruiting | St. Petersburg | Florida | 33705 | United States |
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| Emory Brain Health Center | Recruiting | Atlanta | Georgia | 30329 | United States |
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| The Queen's Medical Center - West Oahu | Recruiting | Honolulu | Hawaii | 96813 | United States |
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| Hawaii Pacific Neuroscience | Recruiting | Honolulu | Hawaii | 96817 | United States |
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| HSHS Medical Group | Recruiting | O'Fallon | Illinois | 62269 | United States |
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| UMass Memorial Medical Center | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Erlanger Neuroscience Institute | Recruiting | Chattanooga | Tennessee | 37403 | United States |
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| Central Texas Neurology Consultants - Elligo | Recruiting | Round Rock | Texas | 78681 | United States |
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| Center for Neurological Disorders - Greenfield | Recruiting | Greenfield | Wisconsin | 53228-1321 | United States |
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