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Идёт набор NCT07532213

A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab

— Наблюдательное Inflammatory Bowel Disease Colitis, Ulcerative Crohn 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: Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease. 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
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

Long-Term Use of Guselkumab: Non-interventional Assessment of Real-world Outcomes

Обзор

The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.

Первичные конечные точки

  • Time to Guselkumab Persistence [Срок оценки: Up to Week 96]
Вторичные конечные точки (12)
  • Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components [Срок оценки: Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12]
  • Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency [Срок оценки: Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12]
  • Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) [Срок оценки: Weeks 12, 48 and 96]
  • Number of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS) [Срок оценки: Weeks 12, 48 and 96]
  • Number of Participants Achieving Clinical Remission for CD as Measured by HBI [Срок оценки: Weeks 12, 48 and 96]
  • Number of Participants Achieving Clinical Remission for UC as Measured by PMS [Срок оценки: Weeks 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI [Срок оценки: Weeks 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS [Срок оценки: Weeks 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI [Срок оценки: Weeks 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-free Clinical Remission for UC as Measured by PMS [Срок оценки: Weeks 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD [Срок оценки: Baseline (Week 0), Weeks 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC [Срок оценки: Baseline (Week 0), Weeks 12, 48 and 96]

Критерии участия

Критерии включения

  • Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)
  • Must have confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
  • Must sign a participation agreement/Informed consent form (ICF) allowing source data verification in accordance with local requirements

Критерии исключения

  • Contraindicated to guselkumab per the label
  • Is currently enrolled in an interventional clinical study
  • Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included
  • History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
  • Is unable to provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern — Bern

Идентификаторы

NCT: NCT07532213 · CNTO1959IBD4008 · CNTO1959IBD4008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗