Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562270
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
CorEvitas International Adolescent Alopecia Areata AA Drug Safety and Effectiveness Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CorEvitas International Adolescent Alopecia Areata AA Drug Safety and Effectiveness Registry
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective observational registry focusing on an adolescent cohort diagnosed with severe alopecia areatareceiving routine care from dermatology providers Visit schedules for patients will be determined by the provider in accordance with routine clinical care and any prescriptions provided to patients will adhere to product availability and local prescribing guidelinesregulations in the country where the participating registry site is located
Detailed Description:
The objective of the registry is to create a cohort of adolescent subjects to evaluate the long-term real-world safety and effectiveness of routine clinical care of treatments for severe AA Data collected through the registry may be used to address a range of research questions and use cases including but not limited to better characterizing the natural history of the disease evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators and research related to drug utilization disease burden and unmet needs Further data collected may be used to generate real world evidence to inform clinical decision making by patients and treating providers
This will be enabled through standardized data collection including validated instruments for patient-reported outcomes PROs and clinician-reported outcomes ClinROs the active evaluation of prevalent and incident comorbidities and adverse events and the recording of medication utilization data
This will be enabled through standardized data collection including validated instruments for patient-reported outcomes PROs and clinician-reported outcomes ClinROs the active evaluation of prevalent and incident comorbidities and adverse events and the recording of medication utilization data
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