Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- difference CDAI between thalidomide group and placebo group
研究概览
简要总结
With the development and application of biological agents, the treatment effect was considerable degree improvement on refractory corn's disease. However, there are quite a part of the CD patients lost response during treatment of using response. Moreover, due to various reasons, there still a lot limited on the using of biological agents in China, that make quite a part of the refractory CD patients lack of further medical treatment options. There has been a RCT study which prove that thalidomide effect and safety on treating refractory CD or who were lost response by using biological agents in Italy, but the object of study is only limited in children and adolescents. There are some small sample studies also confirmed the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT evidence.
详细描述
It will be divided two groups of patients by using randomized, double-blind. One group was treated by thalidomide, the other was placebo. It will be unlocked blind and analysis the effect and safety about thalidomide after 8 weeks. The second, patients still use thalidomide after unlock blind to prove its longtime treatment effect and safety.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years old
- •Diagnosis of patients with CD
- •Disease in the activity: CDA Ⅰ > 150 points, endoscopic see active lesions
- •Refractory: immunosuppressive drugs or biological agents which are used in current treatment is invalid and/or intolerance
排除标准
- •Fiber stenosis caused by gastrointestinal obstruction symptoms
- •Fistula exclude anal fistula
- •Pregnancy or lactation
- •Period of women have fertility program during the study
- •Treatment not foot eight weeks after last IFX
- •Central or peripheral nerve disease
- •Abnormal in liver and renal function
- •Heart function failure
- •Malignant tumor
- •Active tuberculosis
研究组 & 干预措施
thalidomide
thalidomide 100mg tablet by mouth, every night for 8 weeks
干预措施: Thalidomide (Drug)
placebo
placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks
干预措施: placebo(for thalidomide) (Drug)
结局指标
主要结局
difference CDAI between thalidomide group and placebo group
时间窗: 8 weeks
CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says "generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores."
difference SES-CD score between thalidomide group and placebo group
时间窗: 8weeks
SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission.
次要结局
- difference CDAI between different thalidomide dosage group(1 year)
- difference SES-CD score between different thalidomide dosage group(1 year)
研究者
Xiang Gao
Clinical Professor
Sixth Affiliated Hospital, Sun Yat-sen University