Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
A Long-Term, Prospective, Observational, Registry of Patients With Anti-Aquaporin 4 Antibody-Positive (AQP4+) Neuromyelitis Optica Spectrum Disorder (NMOSD) Treated With Alexion Complement Component 5 (C5) Inhibitor Therapies (ALXN-C5IT)
1 other identifier
observational
122
8 countries
33
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2024
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2023
CompletedFirst Posted
Study publicly available on registry
July 28, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
February 10, 2026
February 1, 2026
6.1 years
July 7, 2023
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Participants with a diagnosis of AQP4+ NMOSD who are being treated with ALXN-C5IT at the time of enrollment.
You may qualify if:
- 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.
You may not qualify if:
- Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Clinical Trial Site
Washington D.C., District of Columbia, 20010, United States
Research Site
Boston, Massachusetts, 02114, United States
Clinical Trial Site
Chapel Hill, North Carolina, 27599, United States
Clinical Trial Site
Columbus, Ohio, 43215, United States
Clinical Trial Site
Plano, Texas, 75024, United States
Clinical Trial Site
Milwaukee, Wisconsin, 53215, United States
Clinical Trial Site
Buenos Aires, Argentina
Clinical Trial Site
Buenos Aires, Argentina
Clinical Trial Site
Buenos Aires, Argentina
Clinical Trial Site
Buenos Aires, Argentina
Clinical Trial Site
Burnaby, British Columbia, Canada
Clinical Trial Site
Beijing, China
Clinical Trial Site
Guangzhou, China
Clinical Trial Site
Henan, China
Clinical Trial Site
Shanghai, China
Clinical Trial Site
Sichuan, China
Clinical Trial Site
Wuhan, China
Clinical Trial Site
Dresden, Germany
Clinical Trial Site
Essen, Germany
Clinical Trial Site
München, Germany
Clinical Trial Site
Naples, Italy
Clinical Trial Site
Fukuoka, Japan
Clinical Trial Site
Kawasaki, Japan
Clinical Trial Site
Miyagi, Japan
Clinical Trial Site
Tokyo, Japan
Clinical Trial Site
Daejeon, South Korea
Clinical Trial Site
Gyeonggi-do, South Korea
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Lopez
Hospital Aleman
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2023
First Posted
July 28, 2023
Study Start
February 1, 2024
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR