Ilaris NIS in Korea
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: Ilaris.
- Кому может быть актуально
- Состояния в реестре: Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS), Colchicine Resistance Familial Mediterranean Fever (crFMF), TNF Receptor Associated Periodic Syndrome (TRAPS). Базовые параметры: 2 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 →
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Официальное название
Real Life Non-interventional Study on Safety and Effectiveness of Ilaris® (Canakinumab) 150 mg for Subcutaneous Injection in Hereditary Periodic Fever Syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) Patients and sJIA Patients (REASSURE)
Обзор
This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes, Cryopyrin-associated periodic syndromes (CAPS), colchicine resistance familial Mediterranean fever (crFMF), TNF receptor associated periodic syndrome (TRAPS), Hyper-IgD syndrome / Mevalonate kinase deficiency (HIDS/MKD) or Systemic juvenile idiopathic arthritis (sJIA).
Подробное описание
This is a prospective observational, multicenter, uncontrolled, open-label non-interventional study in ≥2 year and \<19 year-old pediatric and ≥19 year-old adult hereditary periodic fever syndrome patients and ≥2 year and \<19 year-old sJIA patients receiving Ilaris for the treatment of CAPS, crFMF, TRAPS, HIDS/MKD and sJIA, respectively, partially using retrospective observation to collect and evaluate data on the safety and effectiveness of Ilaris in patients receiving this drug in a clinical setting for any of these indications. The whole study period is up to 4 years, consisting of a 2-year enrollment period and 2-year observation period.
As all pediatric and adult hereditary periodic fever syndrome patients and all sJIA patients receiving Ilaris for approved indications will be enrolled, this study has no fixed sample size.
For subjects who started Ilaris before enrolling in this study, the safety and effectiveness baseline and early period data will be retrospectively collected.
Вмешательства
- Биопрепарат Ilaris
Prospective observational study. There is no treatment allocation.
Первичные конечные точки
- Incidence of adverse events and serious adverse events [Срок оценки: Up to 104 weeks from Ilaris treatment]
Вторичные конечные точки (9)
- Proportion of complete responders [Срок оценки: Up to 16 weeks from Liars treatment]
- Proportion of participants with Physician Global Assessment of Disease Activity (PGA) score <2 [Срок оценки: Up to 104 weeks from Ilaris treatment]
- Proportion of patients with C- reactive protein (CRP) serological response [Срок оценки: Up to 104 weeks from Ilaris treatment]
- Proportions of patients with serum amyloid A (SAA) normalization [Срок оценки: Up to 104 weeks from Ilaris treatment]
- Proportion of patients classified in each severity level in the physician's severity assessment of key disease -specific signs and symptoms [Срок оценки: Up to 104 weeks from Ilaris treatment]
- Proportions of patients classified in each severity level in symptoms likely to significantly affect affect physical functioning and vital prognosis [Срок оценки: Up to 104 weeks from Ilaris treatment]
- Percent change from baseline in Health related quality of life (HRQOL) measured by Child Health Questionnaire-Parent Form 50 (CHQ-PF50) [Срок оценки: Up to 104 weeks from Ilaris treatment]
- Percent change from baseline in Health related quality of life (HRQOL) measured by 36-item Short Form Health Survey (SF-36) [Срок оценки: Up to 104 weeks from Ilaris treatment]
- Percent change from baseline in Health related quality of life (HRQOL) measured by Work Productivity and Activity Impairment Specific Health Problem v2.0 (WPAI-SHP) [Срок оценки: Up to 104 weeks from Ilaris treatment]
Критерии участия
Критерии включения
- Written informed consent/assent of the patient or their legal representative/parent (≥2 year and <19 year-old pediatric patient) for voluntarily participating in this study
- Age: ≥2 year and <19 year-old pediatric and ≥19 year-old adult hereditary periodic fever syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) patients and ≥2 year and <19 year-old sJIA patients
- Patient who have an agreement to be treated or who have already started treatment with Ilaris in accordance with the approved label information
Критерии исключения
- Patients receiving Ilaris treatment for autoimmune disease other than CAPS, crFMF, TRAPS, HIDS/MKD or sJIA
- Patients participating in an interventional clinical trial which would have an impact on routine clinical treatment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
South Korea · 1 центр
- Novartis Investigative Site — Seoul
Идентификаторы
NCT: NCT06838143 · CACZ885NKR01