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Идёт набор NCT07541261

A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia

— Наблюдательное 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: 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
Саудовская Аравия
Следующий шаг
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Официальное название

A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia

Обзор

The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) 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 Discontinuation [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 for Crohn's Disease (CD) [Срок оценки: Weeks 0, 1, 2, 4, 8, and 12]
  • Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Ulcerative Colitis (UC) [Срок оценки: Weeks 0, 1, 2, 4, 8, and 12]
  • Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency [Срок оценки: Weeks 0, 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 Corticosteroid-free remission for UC [Срок оценки: Weeks 24, 48 and 96]
  • Number of Participants Achieving Corticosteroid-free remission for CD [Срок оценки: Weeks 24, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC [Срок оценки: Weeks 24, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD [Срок оценки: Weeks 24, 48 and 96]
  • Characteristics of Participants Receiving Guselkumab Treatment: Age [Срок оценки: At Baseline]
  • Characteristics of Participants Receiving Guselkumab Treatment: Sex [Срок оценки: At Baseline]
  • Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use [Срок оценки: At Baseline]

Критерии участия

Критерии включения

  • The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent
  • The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
  • The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification

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

Саудовская Аравия · 1 центр
  • Al Salama Hospital — Jeddah

Идентификаторы

NCT: NCT07541261 · CNTO1959IBD4009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗