Набор скоро начнётся NCT07448402

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

— Наблюдательное Psoriasis Psoriasis Arthritis Psoriasis (PsO)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Guselkumab (GUS), Risankizumab (RISA).
Кому может быть актуально: Состояния в реестре: Psoriasis, Psoriasis Arthritis, Psoriasis (PsO). Базовые параметры: от 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Costa Rica
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System

Обзор

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.

Подробное описание

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.

Вмешательства

Биопрепарат Guselkumab (GUS)
Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic immune-mediated inflammatory condition with substantial clinical and quality-of-life impact. Several biologic classes are available for moderate-to-severe disease, including TNF-α inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors. IL-23-specific inhibitors (guselkumab and risankizumab) selectively block the p19 subunit of IL-23, providing targeted suppression of the Th17 pathway while preserving IL-12-dependent immu
Биопрепарат Risankizumab (RISA)
Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic immune-mediated inflammatory condition with substantial clinical and quality-of-life impact. Several biologic classes are available for moderate-to-severe disease, including TNF-α inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors. IL-23-specific inhibitors (guselkumab and risankizumab) selectively block the p19 subunit of IL-23, providing targeted suppression of the Th17 pathway while preserving IL-12-dependent immu

Первичные конечные точки

Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease [Срок оценки: 5 years]
Safety of Interleukin-23 Inhibitors [Срок оценки: 5 years]

Вторичные конечные точки (5)

Change in Psoriasis Severity [Срок оценки: 5 years]
Articular Disease Activity [Срок оценки: 5 years]
Treatment Persistence [Срок оценки: 5 years]
Laboratory Safety Parameters [Срок оценки: 5 years]
Factors Associated With Clinical Response [Срок оценки: 5 years]

Критерии участия

Критерии включения

Confirmed diagnosis of psoriatic disease, including psoriasis (any clinical variant) and/or psoriatic arthritis based on rheumatologic criteria.
Receiving IL-23 inhibitor therapy (guselkumab or risankizumab).
Treated within participating Costa Rican public health centers.
Availability of sufficient clinical records to complete registry data (history, follow-up, labs).
Age ≥12 years, any sex.