Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06100991
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-10-03
Brief Title:
CorEvitas Generalized Pustular Psoriasis GPP Drug Safety and Effectiveness Registry
Sponsor:
CorEvitas
Organization:
CorEvitas
Study Overview
Official Title:
CorEvitas Generalized Pustular Psoriasis GPP Drug Safety and Effectiveness Registry
Status:
RECRUITING
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:
Prospective observational registry for subjects with GPP under the care of a dermatology investigatorApproximately 200 subjects and 75 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 obtain information on the treatment patterns disease activity progression and the development of comorbidities and adverse events in a cohort of patients with GPP Data collected will be used to better characterize the natural history and longitudinal trajectory of the disease This will be done through the standardized data collection including validated 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 subject 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 GPP 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 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