Registry of Patients with AQP4+ NMOSD Treated with Alexion C5 Inhibitor Therapies
Study Identifier:
D9282C00003
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruiting
Study Details
Medical Condition
- Neuromyelitis Optica Spectrum Disorder
- NMOSD
- AQP4+ NMOSD
Study Drug
Date
Feb 2024 - Mar 2030
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 Years - n/a
Requirements Information
Inclusion and Exclusion 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.
Sex
Female & Male
Age
18 Years - n/a
Study Details
Medical Condition
- Neuromyelitis Optica Spectrum Disorder
- NMOSD
- AQP4+ NMOSD
Study Drug
Date
Feb 2024 - Mar 2030
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 Years - n/a years
Requirements Information
Inclusion and Exclusion 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.
Protocol 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.
Trial Locations
Location
Status
Location
Research Site
Boston, MA, United States, 02114
Status
Recruiting
Location
Clinical Trial Site
Buenos Aires, Argentina
Status
Recruiting
Location
Clinical Trial Site
Burnaby, BC, Canada
Status
Recruiting
Location
Clinical Trial Site
Guangzhou, China
Status
Not yet recruiting
Location
Clinical Trial Site
Wuhan, China
Status
Not yet recruiting
Location
Clinical Trial Site
Beijing, China
Status
Not yet recruiting
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