NCT05043870招募中4 期
Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- endoscopic remission
研究概览
简要总结
This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-18 years old
- •diagnosis of Crohn's Disease
- •Pediatric Crohn's disease Activity Index (PCDAI)>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) >10 before treatment
- •receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids
- •The patient or legal guardian sign the informed consent documents
排除标准
- •history of biological agents targeting at tumor necrosis factor (TNF)
- •Crohn's Disease-related surgery
研究组 & 干预措施
infliximab and immunosuppressives therapy
Experimental
the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week
干预措施: Infliximab and immunosuppressives (Drug)
infliximab therapy
Active Comparator
the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
干预措施: Infliximab (Drug)
结局指标
主要结局
endoscopic remission
时间窗: week 54
The endoscopic remission rate at week 54
clinical remission
时间窗: week 54
The clinical remission rate at week 54
次要结局
- Pediatric Crohn's disease Activity Index score(week0, week2, week6, week14, week22, week30, week38, week46, week54)
研究者
Ying HUANG
Head of department of gastroenterology
Children's Hospital of Fudan University
研究点 (1)
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