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NCT05966467Recruiting

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

Alexion Pharmaceuticals, Inc.

Start Date

2/1/2024

Completion Date

9/27/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Neuromyelitis Optica Spectrum DisorderNMOSDAQP4+ NMOSD

Locations

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