跳至主要内容
临床试验/NCT05861167
NCT05861167Unknown4 期

Efficacy and Safety of Selective Intensive Induction Therapy Based on Ustekinumab Clinical Decision-making Tools in Patients With Crohn's Disease: A Multicenter, Prospective, Randomized, Controlled Study(SIIT-CD Study)

Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
140
试验地点
1
主要终点
Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen

研究概览

简要总结

ustekinumab (UST) can effectively induce and maintain clinical remission and mucosal healing of Crohn's disease (CD), but some patients still have poor response. Dose optimization is an effective way to improve the response rate of UST, and re-intravenous induction is a common way of optimization. For patients with secondary loss of response, about half of the patients can re-respond after dose optimization. We plan to use CDST-UST to stratify the response level of patients before treatment, select patients with poor response, and initially give multiple intravenous therapy as an intensive induction therapy strategy, so as to improve the response rate of these patients and achieve individualized treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with CD;
  • Active period; Age 18-75 years old;
  • UST-CDST scores were used to treat patients with moderate and low responsive activity

排除标准

  • Subjects had undergone extensive colectomy, subtotal colectomy, or total colectomy; The subject currently has ileostomy and colostomy; Patients with significant liver, kidney, endocrine, respiratory, neurological or cardiovascular diseases; Patients with fibrous stenosis and prestenosis dilatation; Contraindications of UST as documented in other specifications.

结局指标

主要结局

Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen

时间窗: week 24

Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen

次要结局

未报告次要终点

研究者

发起方
Sixth Affiliated Hospital, Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiang Gao

Sixth Affiliated Hospital, Sun Yat-sen University

Sixth Affiliated Hospital, Sun Yat-sen University

研究点 (1)

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