Status:
RECRUITING
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Neuromyelitis Optica Spectrum Disorder
NMOSD
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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 peri...
Eligibility Criteria
Inclusion
- 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
- Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05966467
Start Date
February 1 2024
End Date
March 1 2030
Last Update
November 26 2025
Active Locations (33)
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1
Clinical Trial Site
Washington D.C., District of Columbia, United States, 20010
2
Research Site
Boston, Massachusetts, United States, 02114
3
Clinical Trial Site
Chapel Hill, North Carolina, United States, 27599
4
Clinical Trial Site
Columbus, Ohio, United States, 43215