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Набор скоро начнётся NCT07297069

Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial

Фаза II С лечением Acute Severe Ulcerative Colitis

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
В протоколе указаны: Infliximab, Tofacitinib.
Кому может быть актуально
Состояния в реестре: Acute Severe Ulcerative Colitis. Базовые параметры: 18 лет — 65 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
Индия
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

Combination of INFLIXIMAB With TOFACITINIB in ASUC - CINTO Trial

Обзор

In adults hospitalized with acute severe ulcerative colitis who fail to respond to intravenous steroids, does treatment with a combination of infliximab and tofacitinib, compared with infliximab alone or tofacitinib alone, result in higher rates of early clinical remission and mucosal healing, and fewer treatment-related complications over a 10 week period

Подробное описание

Acute severe ulcerative colitis (ASUC) is a life threatening manifestation of ulcerative colitis that requires urgent medical treatment and hospitalization. Despite the use of rapid induction intravenous corticosteroids, some patients fail to respond and require rescue therapy. Infliximab is commonly used as rescue treatment; however, its effectiveness may be reduced in patients with severe inflammation and hypoalbuminemia. As a result, colectomy rates for ASUC remain significant and improved early rescue strategies are needed.

Tofacitinib is an oral Janus kinase inhibitor that targets multiple cytokine pathways involved in ulcerative colitis. It has a rapid onset of action and has shown benefit in severe and steroid-refractory disease. Because infliximab and tofacitinib act on different immunologic targets, their combined use may provide complementary therapeutic effects. Emerging observational data suggest that combining a biologic agent with a small-molecule therapy may be safe and potentially more effective in patients with severe disease who are at high risk for treatment failure.

This study is designed to explore whether the combination of infliximab and tofacitinib offers greater early clinical benefit compared to infliximab alone, tofacitinib alone for adults hospitalized with ASUC who do not respond to intravenous corticosteroids.The goal is to generate preliminary data that may inform future treatment approaches aimed at improving remission rates, accelerating mucosal healing, and reducing the need for colectomy in this high risk population.

Вмешательства

  • Препарат Infliximab
    Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive infliximab as rescue therapy. Infliximab 300 mg will be administered intravenously. This arm evaluates the effectiveness and safety of infliximab monotherapy in inducing early clinical remission and mucosal healing.
  • Препарат Tofacitinib
    Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive tofacitinib as rescue therapy. Tofacitinib will be administered orally at 10 mg twice daily. This arm assesses the effectiveness and safety of tofacitinib monotherapy in inducing early clinical remission and mucosal healing.

Первичные конечные точки

  • Clinical Remission Rate [Срок оценки: Week 1 and Week 4]
Вторичные конечные точки (3)
  • Clinical Response Rate [Срок оценки: Week 1 and Week 4]
  • Mucosal Healing Rate [Срок оценки: Week 4 and Week 12]
  • Treatment Related Adverse Events [Срок оценки: Baseline through Week 12]

Критерии участия

Критерии включения

Adult (aged 18 years to 65 years) patients hospitalised due to ASUC

Критерии исключения

  • Patients with UC who did not meet the Truelove Witts criteria for ASUC.
  • Patients who are already on Tofacitinib / Infliximab.
  • Latent or active tuberculosis.
  • Crohn's or Indeterminate colitis.
  • Mega colon (if the diameter of the transverse colon is 5.5 cm or more, with apparent oedema of the bowel wall on plain abdominal radiographs).
  • Pseudomembranous colitis or concomitant CMV colitis.
  • Intestinal perforation.
  • Massive haemorrhage requiring emergency colectomy.
  • Pregnant or lactating female individuals.
  • Current diagnosis or history of thromboembolic disease patients with severe cardiorespiratory, renal or hepatic Co morbidities.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Индия · 1 центр
  • Asian Institute of Gastroenterology — Hyderabad

Публикации

  • Hickman K, Jordan R, Sonnier W. Combination biologic and small molecule therapy for refractory ulcerative colitis. Gastroenterology. 2022;162(3 Suppl):S103.
  • A genome-scale CRISPR tool for targeting multiple gene family members at once. Nat Plants. 2023 Apr;9(4):511-512. doi: 10.1038/s41477-023-01388-y. No abstract available. PMID 36973416

Идентификаторы

NCT: NCT07297069 · CINTO 1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗