Идёт набор NCT07243782

Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea

— Наблюдательное Hidradenitis Suppurativa Pediatric Plaque Psoriasis Juvenile Idiopathic Arthritis

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: Secukinumab.
Кому может быть актуально: Состояния в реестре: Hidradenitis Suppurativa, Pediatric Plaque Psoriasis, Juvenile Idiopathic Arthritis. Базовые параметры: 6 лет — 100 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: South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Regulatory Post-Marketing Surveillance to Assess Safety and Effectiveness in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea : a rPMS Study

Обзор

Regulatory Post-Marketing Surveillance in hidradenitis suppurativa, pediatric plaque psoriasis and JIA treated with Cosentyx®(secukinumab) in Korea

Подробное описание

This post-marketing study is a multicenter, single-arm, prospective, observational study.

Cosentyx is prescribed within the scope of the approved indications for hidradenitis suppurativa, pediatric plaque psoriasis, enthesitis-related arthritis and juvenile psoriatic arthritis in the juvenile idiopathic arthritis category. The decision to treat patients with the drug will be made within current clinical practice and will be clearly distinguished from the decision to include patients in this investigation. No additional diagnostics or monitoring will be performed for this study beyond what is typically performed in clinical practice.

Вмешательства

Препарат Secukinumab
This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Первичные конечные точки

Number of participants having Adverse Events (AEs) and Serious Adverse Events (SAEs) within each indication [Срок оценки: Up to 24 weeks]

Вторичные конечные точки (12)

Proportion of paticipants achieving 50% reduction in hidradenitis suppurativa clinical response (HiSCR50) - HS participants [Срок оценки: 12 and 24 weeks]
Proportion of participants achieving a severity of 0 or 1 on the hidradenitis supurativa-physician's global assessment (HS-PGA) - HS participants [Срок оценки: 12 and 24 weeks]
Proportion of participants with a 55% or greater reduction in international hidradenitis suppurativa severity scoring system (IHS4-55) - HS participants [Срок оценки: 12 and 24 weeks]
Proportion of participants with a ≥30% reduction in Hidradenitis suppurativa-related skin pain numerical rating scale (NRS) - HS participants [Срок оценки: 12 and 24 weeks]
Proportion of participants with an Hidradenitis supurativa flare - HS participants [Срок оценки: 12 and 24 weeks]
Proportion of participants by Hurley stage - HS participants [Срок оценки: 12 and 24 weeks]
Change from baseline in Psoriasis Area and Severity Index (PASI) - Pediatric plaque psoriasis participants [Срок оценки: 12 and 24 weeks]
Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 - Pediatric plaque psoriasis participants [Срок оценки: 12 and 24 weeks]
Change from baseline in active joints by Tender Joint Count (TJC) - JIA participants [Срок оценки: 12 and 24 weeks]
Change from baseline in active joints by swollen joint count (SJC)- JIA participants [Срок оценки: 12 and 24 weeks]
Change from baseline in clinical juvenile arthritis disease activity score (cJADAS) - JIA participants [Срок оценки: 12 and 24 weeks]
Physician evaluation of participant symptoms [Срок оценки: 12 and 24 weeks]

Критерии участия

Критерии включения

Hidradenitis suppurativa:

Adults 18 years of age and older with moderate to severe hidradenitis suppurativa who are or will be receiving Cosentyx within the scope of approved indication.
Patients who have agreed to participate in study (written informed consent)

Pediatric plaque psoriasis:

Patients with moderate to severe plaque psoriasis between the ages of 6 and 18 years who are receiving or will receive Cosentyx within the scope of approved indication.
Patients with patient or guardian consent to participate in study (written informed consent)

Juvenile idiopathic arthritis:

Enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category patients with enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category between the ages of 6 and 18 years and are receiving or will receive Cosentyx within the scope of approved indication.
Patients with patient or guardian consent to participate in study (written informed consent)