Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238765
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-02
First Post:
2024-01-16
Brief Title:
CorEvitas International Adolescent Atopic Dermatitis AD Drug Safety and Effectiveness Registry
Sponsor:
CorEvitas
Organization:
CorEvitas
Study Overview
Official Title:
CorEvitas International Adolescent Atopic Dermatitis AD Drug Safety and Effectiveness Registry
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider Approximately 1500 subjects and 75 clinical sites in North America and select European countries 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 adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators Further data collected will inform clinical decision making by patients and treating providers This will be done 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 patterns
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 subject adherence
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 subject adherence
Study Oversight
Has Oversight DMC:
None
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?:
None