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Идёт набор NCT06962020

Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis

— Наблюдательное Ulcerative Colitis (UC)

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: first-line biologic：IFX, first-line biologic:VDZ.
Кому может быть актуально
Состояния в реестре: Ulcerative Colitis (UC). Базовые параметры: 18 лет — 70 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
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Официальное название

Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis: A Prospective, Multi-Center, Real-World Study

Обзор

The purpose of this prospective, multicenter, real-world study is to compare the efficacy differences and influencing factors of different first-line biologics in patients with moderate to severe ulcerative colitis. The question that this study aims to answer is: When treating patients with moderate to severe ulcerative colitis, should IFX or VDZ be prioritized as the first-line choice for biologics?, Which biological agent has better therapeutic effect?. Researchers will observe and follow up with patients with moderate to severe ulcerative colitis treated with different biologics on the front line, evaluate their condition changes, eliminate relevant interfering factors, and draw the final conclusion.

Вмешательства

  • Препарат first-line biologic：IFX
    IFX is administered intravenously at a dose of 5-10mg/kg, once at weeks 0, 2, and 6 (or 0, 1, and 5), and then every 8 weeks at a dose of 5mg/kg for maintenance treatment. VDZ is administered intravenously at a dose of 300mg/time, once at weeks 0, 2, and 6, and then every 8 weeks at a dose of 300mg for maintenance treatment.
  • Препарат first-line biologic:VDZ
    IFX is administered intravenously at a dose of 5-10mg/kg, once at weeks 0, 2, and 6 (or 0, 1, and 5), and then every 8 weeks at a dose of 5mg/kg for maintenance treatment. VDZ is administered intravenously at a dose of 300mg/time, once at weeks 0, 2, and 6, and then every 8 weeks at a dose of 300mg for maintenance treatment.

Первичные конечные точки

  • Clinical remission rates and endoscopic remission rates at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologics treatment [Срок оценки: From enrollment to the end of treatment at 2 years.]
Вторичные конечные точки (2)
  • Clinical response rate, endoscopic response rate, and hormone free response rate at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologics treatment [Срок оценки: From enrollment to the end of treatment at 2 years.]
  • Factors affecting the efficacy of two biological agents in the treatment process [Срок оценки: From enrollment to the end of treatment at 2 years.]

Критерии участия

Критерии включения

  • Age range of 18-70 years old, gender not limited;
  • According to international guidelines and consensus, patients with ulcerative colitis should be diagnosed to exclude radiation enteritis, infectious enteritis, tumor related diseases, etc;
  • Patients assessed as moderate to severe ulcerative colitis based on the Mayo score;
  • During the follow-up period, no relevant treatments (drugs and surgery) were used that could affect the assessment of the efficacy of biologics

Критерии исключения

  • Patients with hemodynamic instability;
  • Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR<60ml/min or dialysis patients;
  • Patients allergic to IFX or VDZ;
  • Patients whose primary disease was gastrointestinal malignancy;
  • Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
  • Female patients during pregnancy and breastfeeding (including patients with reproductive needs);
  • Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.);
  • Patients who cannot cooperate with regular follow-up and review of laboratory indicators;
  • Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • Xijing Hospital of Digestive Diseases — Shanxi

Идентификаторы

NCT: NCT06962020 · KY20232425-F-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗