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)
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
- 否
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
Xiang Gao
Sixth Affiliated Hospital, Sun Yat-sen University
Sixth Affiliated Hospital, Sun Yat-sen University
