Идёт набор NCT07517250

A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients

— Наблюдательное Familial Mediterranean Fever Still Disease Systemic Juvenile Idiopathic Arthritis Adult-Onset Still Disease

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Familial Mediterranean Fever, Still Disease, Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still Disease. Базовые параметры: от 1 год · 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: Швейцария
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

Non-interventional Study on the Use of ILARIS® (Canakinumab) Among Familial Mediterranean Fever and Still's Disease Patients Across Europe and Israel

Обзор

This study aims to assess and characterize the treatment patterns, and long-term clinical outcomes and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease (including systemic juvenile idiopathic arthritis \[SJIA\] and adult-onset Still's disease \[AOSD\]) that received canakinumab for at least 6 months.

Первичные конечные точки

Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents [Срок оценки: Up to 3 years]
Percentage of Patients With Partial Remission Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents [Срок оценки: Up to 3 years]
Percentage of Patients With Complete Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents [Срок оценки: Up to 3 years]
Percentage of Patients With Partial Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents [Срок оценки: Up to 3 years]
Percentage of Patients With Poor Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents [Срок оценки: Up to 3 years]
Percentage of Patients With Clinically Inactive FMF Disease After Completing Treatment With Canakinumab [Срок оценки: Up to 3 years]
Percentage of Patients With Complete Remission/Response in Still's Disease After Completing Treatment With Canakinumab [Срок оценки: Up to 3 years]
Percentage of Patients who are Taking Canakinumab and Stopped or Significantly Tapered Administration of Steroids [Срок оценки: Up to 3 years]
Percentage of Patients who Discontinued Canakinumab 6 Months After Initiation by Reason for Discontinuation [Срок оценки: 6 months]

Вторичные конечные точки (12)

Percentage of Patients Using Anakinra, Tocilizumab and Canakinumab as First, Second or Posterior Line of Treatment [Срок оценки: Up to 3 years]
Percentage of Patients Using Colchicine Only or Corticosteroids as First Line of Treatment [Срок оценки: Up to 3 years]
Percentage of Patients who Switch From Anakinra or Tocilizumab to Canakinumab [Срок оценки: Up to 3 years]
Time to Switch From Anakinra or Tocilizumab to Canakinumab [Срок оценки: Up to 3 years]
Percentage of Patients by Reason for Switching From Anakinra or Tocilizumab to Canakinumab Treatment [Срок оценки: Up to 3 years]
Percentage of Patients by Dosing Regimen [Срок оценки: Up to 3 years]
Time From Disease Onset to Prescription of First Biologic Treatment [Срок оценки: Up to 3 years]
Time From Diagnosis to Prescription of First Biologic Treatment [Срок оценки: Up to 3 years]
Percentage of Patients by Concomitant Treatments Received Before Canakinumab Treatment [Срок оценки: 12 months]
Percentage of Patients by Concomitant Treatments Received During Canakinumab Treatment [Срок оценки: Up to 3 years]
Percentage of Patients With Hospitalizations Before Canakinumab Treatment [Срок оценки: 12 months]
Percentage of Patients With Hospitalizations During Canakinumab Treatment [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

Pediatric or adult patients who were prescribed canakinumab before October 2021 and received canakinumab for at least 6 months for the treatment of FMF or Still's disease (including SJIA or AOSD).
Have data on clinical characteristics and treatments available for at least 3 years following the initiation of canakinumab treatment.