NCT05966467

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 122 (estimated)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Neuromyelitis Optica Spectrum Disorder
• NMOSD
• AQP4+ NMOSD

Timeline

• Start date: 2024-02-01
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2023-07-28
• Last updated: 2026-02-10

Locations

33 sites across 8 countries: United States, Argentina, Canada, China, Germany, Italy, Japan, South Korea