The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease：a Randomized, Open Label, Single-center Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- loss of response(LOR) rate at one year
研究概览
简要总结
This study aim to identify the therapeutic effect of azathioprine during infliximab(IFX) treatment in Crohn's disease (CD).Half of patients will receive azathioprine and infliximab combination therapy at the same time. The other half patients will be given infliximab therapy first and then receive azathioprine 14 weeks later.
详细描述
Anti-tumor necrosis factor agents were widely used for many years and were proved to be most reliable drugs in Crohn's disease (CD). About one-third of the patients would develop a secondary lost of response after initiating IFX therapy in one year follow-up. Immunosuppressor was thought to be a useful agent to reduce loss of response rate of infliximab.But It remain unclear when should us add immunosuppressor during infliximab therapy.This study aim to find the most valuable timepoint to initiate combination therapy to maximize therapeutic effect and minimize the adverse effect.
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
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD patients need infliximab and azathioprine combination therapy
排除标准
- •patients had lost response to infliximab or azathioprine previously patients intolerable to infliximab or azathioprine patients need to use 5-Aminosalicylates(5-ASA) patients had participated to other clinical study in two months
研究组 & 干预措施
infliximab and azathioprine at week 0
infliximab and azathioprine combination at week 0
干预措施: infliximab and azathioprine combination at week 0 (Drug)
infliximab and azathioprine at week 14
infliximab and azathioprine combination at week 14
干预措施: infliximab and azathioprine combination at week 14 (Drug)
结局指标
主要结局
loss of response(LOR) rate at one year
时间窗: one year
LOR was defined as recurrence or worsening of symptoms after achieving remission or response that required IFX dose intensification, addition of concomitant therapy, or discontinuation of IFX.
次要结局
- Simple Endoscopic Score for Crohn's Disease(SES-CD) at one year(one year)
- Mucosal healing（MH）status at one year(one year)