Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
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.
Conditions:
🦠 Neuromyelitis Optica Spectrum Disorder 🦠 NMOSD 🦠 AQP4+ NMOSD
🗓️ Study Start (Actual) 30 August 2023
🗓️ Primary Completion (Estimated) 30 September 2026
✅ Study Completion (Estimated) 30 September 2026
👥 Enrollment (Estimated) 122
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 July 2023
  • First Submitted that Met QC Criteria 21 July 2023
  • First Posted 28 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 January 2024
  • Last Update Posted 1 February 2024
  • Last Verified January 2024