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Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab (Soliris®) and ravulizumab (Ultomiris®).
At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participants' medical history and gMG disease treatment history. Following enrollment, prospective data collection will be performed using data obtained as part of the routine clinical care and through patient-reported outcome methods in use. Data will be collected using an electronic data capture system. The duration of data collection for the Registry will be up to 5 years from the day of enrollment.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score | The MG-ADL is an eight-item patient-reported outcome measure assessing MG symptoms and functional activities related to activities of daily living.48 Each of the items is scored from 0 (normal) to 3 (most severe), providing a total MG-ADL score ranging from 0 to 24, where higher scores indicate greater severity of symptoms. | Approximately 5 years from enrollment |
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Inclusion Criteria:
Exclusion Criteria:
1. Participants currently enrolled in an Alexion-sponsored interventional clinical study for treatment of gMG cannot be enrolled in the Alexion gMG Registry while enrolled/participating in the clinical study for gMG therapy.
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Participants with a diagnosis of gMG who are treated with Alexion C5IT at the time of enrollment, or have ever been treated with Alexion C5IT prior to enrollment, and meet the inclusion criteria and exclusion criteria are eligible for registry participation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. (Sponsor) | Contact | 1-855-752-2356 | clinicaltrials@alexion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Recruiting | Birmingham | Alabama | 35294 | United States | |
| Clinical Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40812271 | Derived | Howard JF Jr, Dodig D, Zeinali L, Macwan SP, Yegin A, Pulley MT, Rodrigues E, Narayanaswami P. First analysis of the Myasthenia Gravis SPOTLIGHT Registry: outcomes with eculizumab and ravulizumab. J Neurol Sci. 2025 Sep 15;476:123628. doi: 10.1016/j.jns.2025.123628. Epub 2025 Jul 16. |
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| Recruiting |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Clinical Trial Site | Recruiting | Fresno | California | 93710 | United States |
| Clinical Trial Site | Recruiting | Orange | California | 92868 | United States |
| Clinical Trial Site | Recruiting | Rancho Mirage | California | 92270 | United States |
| Clinical Trial Site | Recruiting | Sylmar | California | 91342 | United States |
| Clinical Trial Site | Recruiting | Colorado Springs | Colorado | 80907 | United States |
| Clinical Trial Site | Recruiting | Fort Collins | Colorado | 80528 | United States |
| Clinical Trial Site | Recruiting | New Haven | Connecticut | 06520 | United States |
| Clinical Trial Site | Recruiting | Washington D.C. | District of Columbia | 10010 | United States |
| Clinical Trial Site | Recruiting | Clearwater | Florida | 33761 | United States |
| Clincal Trial Site | Recruiting | Gainesville | Florida | 32608 | United States |
| Clinical Trial Site | Recruiting | Jacksonville | Florida | 32209 | United States |
| Clinical Trial Site | Recruiting | Tampa | Florida | 33612 | United States |
| Clinical Trial Site | Recruiting | Augusta | Georgia | 30912 | United States |
| Clinical Trial Site | Recruiting | Iowa City | Iowa | 52242 | United States |
| Clinical Trial Site | Recruiting | Lexington | Kentucky | 40503 | United States |
| Clinical Trial Site | Recruiting | Boston | Massachusetts | 02215 | United States |
| Clinical Trial Site | Recruiting | Lansing | Michigan | 48824 | United States |
| Clinical Trial Site | Recruiting | Columbia | Missouri | 65212 | United States |
| Clinical Trial Site | Recruiting | New Hyde Park | New York | 11042 | United States |
| Clinical Trial Site | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| Clinical Trial Site | Recruiting | Charlotte | North Carolina | 28207 | United States |
| Clinical Trial Site | Recruiting | Durham | North Carolina | 27705 | United States |
| Clinical Trial Site | Recruiting | Dayton | Ohio | 45459 | United States |
| Clinical Trial Site | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Trial Site | Recruiting | Chattanooga | Tennessee | 37403 | United States |
| Clinical Trial Site | Recruiting | Knoxville | Tennessee | 37920 | United States |
| Clinical Trial Site | Recruiting | Dallas | Texas | 75206 | United States |
| Clinical Trial Site | Recruiting | Houston | Texas | 77030 | United States |
| Clinical Trial Site | Recruiting | Burlington | Vermont | 05401 | United States |
| Clinical Trial Site | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
| Clinical Trial Site | Recruiting | Vienna | 1090 | Austria |
| Clinical Trial Site | Recruiting | Brampton | Ontario | L6R 3J7 | Canada |
| Clinical Trial Site | Recruiting | London | Ontario | N6A 5A5 | Canada |
| Clinical Trial Site | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
| Clinical Trial Site | Recruiting | Chengdu | Sichuan | 610041 | China |
| Clinical Trial Site | Recruiting | Beijing | 100730 | China |
| Clinical Trial Site | Recruiting | Changchun | 130021 | China |
| Clinical Trial Site | Recruiting | Chengdu | 610072 | China |
| Clinical Trial Site | Recruiting | Guangzhou | 510080 | China |
| Clinical Trial Site | Recruiting | Jinan | 250021 | China |
| Clinical Trial Site | Recruiting | Nanchang | 330006 | China |
| Clinical Trial Site | Recruiting | Qingdao | 266003 | China |
| Clinical Trial Site | Recruiting | Shijiazhuang | 050000 | China |
| Clinical Trial Site | Recruiting | Hanover | Hannover | 30625 | Germany |
| Clinical Trial Site | Recruiting | Milan | 20133 | Italy |
| Clinical Trial Site | Recruiting | Naples | 80138 | Italy |
| Clinical Trial Site | Recruiting | Abhā | 62523 | Saudi Arabia |
| Clinical Trial Site | Recruiting | Jeddah | 22384 | Saudi Arabia |
| Clinical Trial Site | Recruiting | Riyadh | 14611 | Saudi Arabia |
| 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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