Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05966467
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-07-07
Brief Title:
Registry of Patients With AQP4 NMOSD Treated With Alexion C5 Inhibitor Therapies
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None