Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

Launched by ALEXION PHARMACEUTICALS, INC. · Jul 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of a specific treatment called Alexion C5 inhibitors in patients with a condition known as AQP4+ Neuromyelitis Optica Spectrum Disorder (NMOSD). NMOSD is a rare autoimmune disease that affects the spinal cord and eyes, leading to serious health issues. The trial aims to gather information on how well this treatment works and its safety by collecting data from patients who are already receiving the medication. Researchers will also look into how this treatment affects patients' quality of life and their overall health outcomes.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of AQP4+ NMOSD. They should currently be receiving Alexion C5 inhibitor therapy for preventing relapses of their condition. Participants will be asked to share information about their past treatments and health history. This study is a great opportunity for eligible patients to contribute to our understanding of this treatment's impact in real-world settings.

Gender

ALL

Eligibility criteria

• 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.