Меню
Идёт набор NCT07102368

A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany

— Наблюдательное Inflammatory Bowel Disease Colitis, Ulcerative Crohn's 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's 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects

Обзор

The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.

Первичные конечные точки

  • Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) [Срок оценки: Week 48]
  • Percentage of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) [Срок оценки: Week 48]
Вторичные конечные точки (12)
  • Time to Guselkumab Discontinuation [Срок оценки: Up to Week 96]
  • Change in Stool Frequency Within the First 4 Weeks of Guselkumab Administration [Срок оценки: Up to Week 4]
  • Change in Rectal Bleeding Within First 4 Weeks of Guselkumab Administration [Срок оценки: Up to Week 4]
  • Change in Abdominal Pain Within the First 4 Weeks of Guselkumab Administration [Срок оценки: Up to Week 4]
  • Change in Bowel Urgency and Nocturnal Bowel Movement (NBM) Within the First 4 Weeks of Guselkumab Administration [Срок оценки: Up to Week 4]
  • Percentage of Participants Achieving Clinical Response for CD as Measured by HBI [Срок оценки: Up to Week 96]
  • Percentage of Participants Achieving Clinical Response for UC as Measured by PMS [Срок оценки: Up to Week 96]
  • Percentage of Participants Achieving Clinical Remission for CD as Measured by HBI [Срок оценки: Up to Week 96]
  • Percentage of Participants Achieving Clinical Remission for UC as Measured by PMS [Срок оценки: Up to Week 96]
  • Percentage of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI [Срок оценки: Up to Week 96]
  • Percentage of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS [Срок оценки: Up to Week 96]
  • Percentage of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI [Срок оценки: Up to Week 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
  • Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements
  • By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study

Критерии исключения

  • Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy
  • Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included
  • Has had a colectomy and/or a pouch
  • Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \& Johnson (J\&J)

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
  • Praxis Fur Gastroenteroligie — Berlin

Идентификаторы

NCT: NCT07102368 · CNTO1959IBD4002 · CNTO1959IBD4002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗