Long-term registry of patients with AQP4-positive neuromyelitis optica treated with C5 inhibitors
Follows adults with AQP4-positive NMOSD treated with Alexion C5 inhibitor therapies.
Key facts
- Who runs it
- Alexion Pharmaceuticals, Inc.
- Where
- Buenos Aires, ArgentinaSee the siteAlso in 7 other countries, 24 sites
- Trial code
- Registry title
- Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 30 Aug 2023
- Expected to end
- 27 Sept 2029
- Type of study
- Observational
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with AQP4+ NMOSD who already take eculizumab or ravulizumab to prevent relapses. It follows their health over the long term.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Confirmed diagnosis of AQP4+ NMOSD (neuromyelitis optica spectrum disorder with anti-aquaporin 4 antibodies).
- Earlier treatment
- Must be treated with eculizumab or ravulizumab to prevent relapses, in line with the local label. At least 1 dose of eculizumab within 4 weeks before joining, or at least 1 dose of ravulizumab within 12 weeks before joining. Dosing history since the start and the number and types of relapses from 1 year before the start must be available.
- Biomarker or test result
- Anti-aquaporin 4 antibody-positive (AQP4+).
Main reasons for not taking part
- Currently in a clinical study testing a drug for AQP4+ NMOSD
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug
Where in Argentina
Also in 7 other countries, 24 sites
- Buenos AiresHospital not named in the registryContact: Pablo LopezTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Long-term registry of patients with AQP4-positive neuromyelitis optica treated with C5 inhibitorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 October 2026