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Идёт набор NCT07642557

Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)

— Наблюдательное Chronic Spontaneous Urticaria

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: Chronic Spontaneous Urticaria. Базовые параметры: от 18 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
Германия
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

Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study (REASSERT) - Local Adaptation in Germany From Global Umbrella Protocol (CLOU064A2402)

Обзор

Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.

Подробное описание

This is a prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, covering a broader, real-world clinical practice population. This local Germany study is part of an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program (CLOU064A2402).

Первичные конечные точки

  • Achievement of well-controlled disease (UCT7 ≥ 12) [Срок оценки: 12 weeks after initiating remibrutinib treatment]
Вторичные конечные точки (12)
  • Number and proportion of participants with well-controlled disease and complete disease [Срок оценки: Up to 24 months]
  • Change from baseline (CFB) in UCT score [Срок оценки: Up to 24 months]
  • Change from Baseline in UAS7 score ≥ minimal important difference [Срок оценки: Up to 24 months]
  • Change from baseline in UAS7 score [Срок оценки: Up to 24 months]
  • Number of weeks without angioedema [Срок оценки: Up to 24 months]
  • Change in Angioedema Control Test (AECT) [Срок оценки: Baseline, up to 24 months]
  • Number of participants with rescue medication requirement [Срок оценки: Up to 24 months]
  • Characterize CSU relapse [Срок оценки: Up to 24 months]
  • UCT7 score [Срок оценки: Up to 12 weeks]
  • UAS7 score [Срок оценки: Up to 12 weeks]
  • Number of participants with administration of remibrutinib according to label [Срок оценки: Up to 24 weeks]
  • Number of participants with usage of concomitant sgH1-AHs and additional prescribed CSU treatments [Срок оценки: Up to 24 weeks]

Критерии участия

Критерии включения

7.2.1 Inclusion criteria Patients must meet all the following criteria to be eligible for inclusion in this study.

  • Patients with a confirmed diagnosis of primary CSU by the treating physician.
  • Aged at least 18 years on the date of enrollment.
  • Written informed consent of the patient to participate in the study and willingness to complete full follow-up period of 24 months.
  • Cohort-specific observational inclusion criteria:
  • Cohort 2: Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label.
  • Cohort3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Note, occasional steroid rescue medication is out of scope for cohort definition. If a patient had been on continuous steroids for at least 3 weeks during treatment history, they will be included in cohort 3.

Критерии исключения

Patients are excluded if they meet any of the following criteria:

  • Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with remibrutinib.
  • Patients within the safety follow-up phase of a previous interventional or non-interventional study.
  • Patients who received remibrutinib at any time in the past.
  • Patients not capable or willing to continuously provide ePRO/eDiary data via electronic means throughout the duration of the study.
  • Patients who are treated with remibrutinib outside of the local label.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Novartis Investigative Site — Düren

Идентификаторы

NCT: NCT07642557 · CLOU064ADE02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗