Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-31 @ 12:32 AM
Study NCT ID:
NCT04886492
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-10
First Post:
2021-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Sponsor:
CorEvitas
Organization:
Study Overview
Official Title:
CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
This is a Prospective, observational research study for patients with NMOSD under the care of a licensed neurologist. Approximately 800 patients and 35 clinical sites in North America will be recruited to participate with no defined upper limit for either target.
Detailed Description:
The objective of the registry is to create a cohort of patients with NMOSD. Data collected will be used to prospectively study the natural history of NMOSD, real-word effectiveness and safety of medications used to treat NMOSD, and drug utilization treatment patterns. Additionally, the data will be used to systematically evaluate the burden for patients with NMOSD and the impact of therapies on quality of life. This will be done through real time capture and adjudication of relapses, the standardized collection of patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.
Personal information is also collected from each consenting registry patient allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of NMOSD for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and patient adherence.
Consent for additional ad hoc surveys will be solicited which can allow evaluation of additional aspects of the disease impact such as care giver burden or impact of disease on productivity.
Personal information is also collected from each consenting registry patient allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of NMOSD for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and patient adherence.
Consent for additional ad hoc surveys will be solicited which can allow evaluation of additional aspects of the disease impact such as care giver burden or impact of disease on productivity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: