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Идёт набор NCT07598422

A Study to Assess the Effectiveness and Safety of Canakinumab in Clinical Use in Patients With Schnitzler's Syndrome

— Наблюдательное Schnitzler Syndrome

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: Schnitzler Syndrome. Базовые параметры: от 0 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
Япония
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

Specified Use-Results Study of ILARIS Solution for S.C. Injection (Schnitzler's Syndrome)

Обзор

The aim of this study is to assess the effectiveness and safety of Ilaris (canakinumab) in clinical use in patients with Schnitzler's syndrome.

Первичные конечные точки

  • Proportion of Patients Achieving Complete Clinical Response in the Period From 7 Days to 8 Weeks After the First Dose [Срок оценки: Day 8 to Week 8]
  • Proportion of Patients Achieving Partial or Complete Clinical Response at all Time Points From 7 Days After the First Dose to 48 Weeks After the First Dose [Срок оценки: Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Rate of Each Clinical Response [Срок оценки: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Mean PGA Score [Срок оценки: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Change From Baseline in PGA Score [Срок оценки: Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Mean White Blood Cell Count [Срок оценки: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Change From Baseline in White Blood Cell Count [Срок оценки: Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Mean Neutrophil Count [Срок оценки: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Change From Baseline in Neutrophil Count [Срок оценки: Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Mean C-reactive Protein (CRP) Level [Срок оценки: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
Вторичные конечные точки (2)
  • Number and Percentage of Patients With Adverse Reactions [Срок оценки: From Baseline to Week 48]
  • Number and Percentage of Patients With Serious Adverse Events [Срок оценки: From Baseline to Week 48]

Критерии участия

Критерии включения

1\. Patients diagnosed with Schnitzler's syndrome using canakinumab for the first time for the indication of Schnitzler's syndrome as described in the package insert.

Patients starting treatment with canakinumab before conclusion of the contract for this study will also be included in the study so that all patients diagnosed with Schnitzler's syndrome who received canakinumab will be registered in this study.

Критерии исключения

  • Patients previously treated with canakinumab in Study IACT21071.
  • All patients treated with canakinumab for the following indications:

Indications: Cryopyrin-associated periodic syndromes (familial cold autoinflammatory syndrome, Muckle-Wells syndrome, neonatal onset multisystem inflammatory disease), hyper immunoglobulin D (IgD) syndrome (mevalonate kinase deficiency), tumor necrosis factor (TNF) receptor-associated periodic syndrome, familial mediterranean fever, systemic juvenile idiopathic arthritis, adult-onset Still's disease.

  • Patients receiving canakinumab for off-label use under the Clinical Trials Act or GCP (e.g., patient-proposed healthcare services, investigator-initiated clinical trial).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Япония · 2 центра
  • Novartis Investigative Site — Kanoya
  • Novartis Investigative Site — Osaka

Идентификаторы

NCT: NCT07598422 · CACZ885C21401

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗