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临床试验/NCT07600255
NCT07600255已完成不适用

Assessment on the Deep Remission Rate and Its Influencing Factors of Individualized Ustekinumab Therapy in Patients With Crohn's Disease

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
试验地点
1

研究概览

简要总结

In alignment with the STRIDE-II consensus, the therapeutic goal for Crohn's disease (CD) has shifted towards "deep remission," which necessitates both mucosal and transmural healing. Recognizing the limitations of relying solely on endoscopic evaluation, this study aims to comprehensively assess the week-44 deep remission status in CD patients undergoing ustekinumab (UST) therapy. By systematically investigating baseline clinical, serological, and sonographic parameters, this research seeks to identify key predictive factors for deep remission, thereby providing robust clinical evidence to guide proactive and personalized UST optimization strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1: Diagnosed with moderate to severe Crohn's disease 2.UST monotherapy 3.Follow-up time ≥44 weeks

排除标准

  • UST combined with glucocorticoids, immunosuppressants, other biological agents or small molecule drugs
  • complicated with infectious diseases (active tuberculosis, septicemia, etc.), cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, malignant tumors
  • combined with systemic lupus erythematosus, rheumatoid arthritis and other autoimmune diseases
  • pregnancy or lactation
  • Clinical data missing > 30%

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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