Меню
Идёт набор NCT07302360

A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis

— Наблюдательное Colitis, Ulcerative

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. 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
Китай
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

Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study

Обзор

The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \[part of large intestine\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.

Первичные конечные точки

  • Percentage of Participants Achieving Clinical Response at Week 12 [Срок оценки: At Week 12]
Вторичные конечные точки (12)
  • Percentage of Participants Achieving Clinical Response at Week 24 and Week 48 [Срок оценки: At Week 24 and Week 48]
  • Percentage of Participants Achieving Symptomatic Response at Week 2 [Срок оценки: At Week 2]
  • Mean Change from Baseline in Stool Frequency Subscore (SFS) Over Week 2 [Срок оценки: From Baseline to Week 2]
  • Mean Change from Baseline in RBS Over Week 2 [Срок оценки: From Baseline to Week 2]
  • Percentage of Participants Achieving Clinical Remission at Week 12, Week 24 and Week 48 [Срок оценки: At Week 12, Week 24 and Week 48]
  • Percentage of Participants Achieving Symptomatic Remission at Week 2 [Срок оценки: At Week 2]
  • Percentage of Participants Achieving Steroid-Free Remission at Week 12, 24 and 48 [Срок оценки: At Weeks 12, 24 and 48]
  • Percentage of Participants Achieving Sustained Remission at Week 24 and Week 48 [Срок оценки: At Week 24 and Week 48]
  • Percentage of Participants with Endoscopic Improvement (Healing) at Week 24 and Week 48 [Срок оценки: At Week 24 and Week 48]
  • Percentage of Participants Achieving Endoscopic Remission (Normalization) at Week 24 and Week 48 [Срок оценки: At Week 24 and Week 48]
  • Percentage of Participants Discontinuing from Treatment [Срок оценки: Up to Week 48]
  • Percentage of Participants Switching from Treatment [Срок оценки: Up to Week 48]

Критерии участия

Критерии включения

  • Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (>=) 2; c) Mayo rectal bleeding subscore (RBS) >= 1 at baseline
  • Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert
  • Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment
  • Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements

Критерии исключения

  • Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy
  • Contraindicated to guselkumab per the label
  • Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab
  • Participants who will be receiving guselkumab therapy combined with a second advanced therapy
  • Participants with a history of colectomy and/or pouch

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 10 центров
  • Peking Union Medical College Hospital — Пекин
  • Peking University People's Hospital — Пекин
  • Changzhou No 2 Peoples Hospital — Changzhou
  • The First Affiliated Hospital Sun Yat-Sen University — Гуанчжоу
  • The Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
  • The Second Affiliated Hospital of Zhejiang University — Ханчжоу
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Ханчжоу
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Нанкин
  • … и ещё 2 центра

Идентификаторы

NCT: NCT07302360 · CNTO1959UCO4003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗