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Combined Advanced Targeted Therapy for Inflammatory Bowel Disease

2026年6月21日 更新者：Yongquan Shi、Xijing Hospital of Digestive Diseases

Efficacy and Safety of Combined Advanced Targeted Therapy for Inflammatory Bowel Disease: A Prospective, Multicenter, Real-World Study

The aim of this retrospective and prospective observational study is to investigate and compare the real-world effectiveness and safety of different dual-target combination therapies in patients with inflammatory bowel disease (IBD).

The key questions to be addressed are:

In patients with refractory IBD who receive either two biologic agents or one biologic agent plus one small molecule drug, what is the real-world effectiveness and safety of different combination regimens?

The researchers will conduct a retrospective analysis of medical records and electronic health data from patients diagnosed with IBD, and will enroll and document patients receiving combination advanced targeted therapy (CATT) for long-term follow-up. The treatments received by these patients are part of routine first-line clinical care or routine rescue clinical care. All treatment decisions were made by treating clinicians according to the standard of care; the investigator did not assign or modify any therapeutic interventions. Data will be collected during a defined follow-up period to compare the real-world effectiveness and safety profiles of different treatment exposure strategies.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a retrospective and prospective observational cohort study. All described interventions are part of routine clinical care for patients with inflammatory bowel disease (IBD). Treatment decisions were made by treating clinicians according to the standard of care; the investigator did not prospectively assign, modify, or control any therapeutic interventions. Participants did not receive any intervention specifically for the purpose of this study. The study only involves retrospective analysis of existing medical records to compare real-world outcomes between different treatment exposure patterns.

研究类型

观察性的

注册 (实际的)

117

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Shaanxi
      • Xi'an、Shaanxi、中国、710005
        • Xijing Hosipital of Digestive Disease

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

This is a multicenter, retrospective and prospective cohort study conducted at 4 tertiary inflammatory bowel disease (IBD) centers in China from April 2023 to April 2026. A total of 117 patients with IBD were enrolled. All patients received Combined Advanced Targeted Therapy (either two biologic agents, or one biologic agent together with one small molecule agent).

描述

Inclusion Criteria:

  1. Patients diagnosed with IBD;
  2. Patients treated with Combined Advanced Targeted Therapy at 4 tertiary IBD centers in China from June 2023 to December 2026.
  3. Patients with complete and available clinical, endoscopic, and follow-up data；
  4. Patients for whom the study was approved by the Institutional Research 5.Ethics Committee and conducted in accordance with the Declaration of Helsinki.

Exclusion Criteria:

  • 1.Patients with hemodynamic instability; 2.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; 3.Patients allergic to biologic agents or small molecule agents; 4.Patients whose primary disease was gastrointestinal malignancy; 5.Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.; 6.Female patients during pregnancy and breastfeeding (including patients with reproductive needs)； 7.Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.); 8.Patients with missing key data for outcome assessment; 9.Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
IBD Patients with Combined Advanced Targeted Therapy
Group/Cohort Description: This retrospective and prospective observational cohort includes patients with inflammatory bowel disease (IBD) who received combination therapy (two biologic agents or one biologic agent and one small molecule agent) in routine clinical practice. All treatment decisions were made by treating clinicians according to the standard of care; the investigator did not assign or modify any therapeutic interventions, and only retrospectively collected and analyzed clinical outcomes from medical records.
药品：Combination therapy
Combination therapy in this study is defined as the concurrent use of either two biologic agents, or one biologic agent together with one small molecule agent.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
clinical response/remission rate at week 12.
大体时间：week 12
Clinical remission is defined as a Mayo score ≤ 2 with no subscore > 1 and a rectal bleeding subscore of 0;
week 12
Colectomy-free rate within 90 days
大体时间：90 days
The proportion of IBD patients who did not undergo colectomy within 90 days after the Combined Advanced Targeted Therapy
90 days

次要结果测量

结果测量
大体时间
Adverse events (AEs) rate
大体时间：90 days
90 days
Endoscopic response/remission rate at week 12
大体时间：week 12
week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Xijing Hospital of Digestive Diseases

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年4月20日

初级完成 (实际的)

2026年5月10日

研究完成 (实际的)

2026年6月10日

研究注册日期

首次提交

2026年6月16日

首先提交符合 QC 标准的

2026年6月16日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月21日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • KY20232425-F-1-2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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