Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:24 PM
Study NCT ID:
NCT07448402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease
Sponsor:
Caja Costarricense de Seguro Social
Organization:
Study Overview
Official Title:
National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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:
The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:
* Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
* What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
* Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.
* Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
* What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
* Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.
Detailed Description:
Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic inflammatory condition with substantial clinical and functional impact. Although IL-23 inhibitors such as guselkumab and risankizumab have shown high efficacy and favorable safety in international trials, real-world evidence in Latin America-and particularly Costa Rica-is limited. Differences in comorbidities, population genetics, access to therapy, and health-system factors may influence treatment response and safety outcomes.
This national observational registry is designed to generate standardized real-world data on patients with psoriatic disease treated with IL-23 inhibitors within the Costa Rican public health system. The registry will collect demographic and clinical characteristics, dermatologic and rheumatologic disease activity scores, treatment patterns, persistence, and adverse events over time. The resulting evidence will support clinical decision-making, optimize therapeutic strategies, and inform national health policy regarding biologic therapies for psoriatic disease.
This national observational registry is designed to generate standardized real-world data on patients with psoriatic disease treated with IL-23 inhibitors within the Costa Rican public health system. The registry will collect demographic and clinical characteristics, dermatologic and rheumatologic disease activity scores, treatment patterns, persistence, and adverse events over time. The resulting evidence will support clinical decision-making, optimize therapeutic strategies, and inform national health policy regarding biologic therapies for psoriatic disease.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: