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Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.
At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participant's medical history and AQP4+ NMOSD treatment history for the time period beginning 1 year prior to ALXN-C5IT initiation through Registry enrollment. The duration of data collection for the Registry will be approximately 5 years from the day the last participant is enrolled.
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| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) | The ARR is defined as the total number of relapses divided by the total number of participant-years. | Up to approximately 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with a diagnosis of AQP4+ NMOSD who are being treated with ALXN-C5IT at the time of enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. (Sponsor) | Contact | 1-855-752-2356 | clinicaltrials@alexion.com |
| Name | Affiliation | Role |
|---|---|---|
| Pablo Lopez | Hospital Aleman | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Research Site | Recruiting | Boston | Massachusetts | 02114 | United States |
| Clinical Trial Site | Not yet recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Clinical Trial Site | Recruiting | Columbus | Ohio | 43215 | United States |
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| Clinical Trial Site | Recruiting | Plano | Texas | 75024 | United States |
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| Clinical Trial Site | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
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| Clinical Trial Site | Recruiting | Buenos Aires | Argentina |
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| Clinical Trial Site | Not yet recruiting | Buenos Aires | Argentina |
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| Clinical Trial Site | Recruiting | Buenos Aires | Argentina |
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| Clinical Trial Site | Recruiting | Buenos Aires | Argentina |
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| Clinical Trial Site | Recruiting | Burnaby | British Columbia | Canada |
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| Clinical Trial Site | Not yet recruiting | Beijing | China |
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| Clinical Trial Site | Not yet recruiting | Guangzhou | China |
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| Clinical Trial Site | Not yet recruiting | Henan | China |
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| Clinical Trial Site | Not yet recruiting | Shanghai | China |
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| Clinical Trial Site | Not yet recruiting | Sichuan | China |
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| Clinical Trial Site | Not yet recruiting | Wuhan | China |
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| Clinical Trial Site | Recruiting | Dresden | Germany |
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| Clinical Trial Site | Recruiting | Essen | Germany |
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| Clinical Trial Site | Not yet recruiting | München | Germany |
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| Clinical Trial Site | Recruiting | Naples | Italy |
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| Clinical Trial Site | Recruiting | Fukuoka | Japan |
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| Clinical Trial Site | Recruiting | Kawasaki | Japan |
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| Clinical Trial Site | Recruiting | Miyagi | Japan |
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| Clinical Trial Site | Not yet recruiting | Tokyo | Japan |
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| Clinical Trial Site | Recruiting | Daejeon | South Korea |
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| Clinical Trial Site | Recruiting | Gyeonggi-do | South Korea |
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| Clinical Trial Site | Recruiting | Seoul | South Korea |
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| Clinical Trial Site | Recruiting | Seoul | South Korea |
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| Clinical Trial Site | Recruiting | Seoul | South Korea |
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| Clinical Trial Site | Recruiting | Seoul | South Korea |
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| Clinical Trial Site | Recruiting | Seoul | South Korea |
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| Clinical Trial Site | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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