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Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

NCT05966467

RecruitingN/A

Sponsor: Alexion Pharmaceuticals, Inc.

Conditions: Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD

Countries: United States, Argentina, Canada, China, Germany, Italy, Japan, South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Participant is ≥ 18 years of age at the time of enrollment in the Registry.
* Participant must have a confirmed diagnosis of AQP4+ NMOSD.
* At the time of enrollment in the Registry, participants must be receiving treatment with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent with the local label. Specifically, they should have received at least 1 dose of eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within 12 weeks prior to enrollment.
* Participants must have both the following historical data available to be enrolled in the Registry: ALXN-C5IT dosing information since initiation and number and types of relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment.

Exclusion Criteria:

* Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.
Locations (33)
  • Washington D.C., District of Columbia, United States
  • Boston, Massachusetts, United States
  • Chapel Hill, North Carolina, United States
  • Columbus, Ohio, United States
  • Plano, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Burnaby, British Columbia, Canada
  • Beijing, China
  • Guangzhou, China
  • Henan, China
  • Shanghai, China
  • Sichuan, China
  • Wuhan, China
  • Dresden, Germany
  • Essen, Germany
  • München, Germany
  • Naples, Italy
  • Fukuoka, Japan
  • Kawasaki, Japan
  • Miyagi, Japan
  • Tokyo, Japan
  • Daejeon, South Korea
  • Gyeonggi-do, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • + 3 more on CT.gov