An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving ASAS20 improvement.
研究概览
简要总结
This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not necessary. The adverse events at any time were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 to 65 years old, having signed the informed consent;
- •fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
- •have inflammatory back pain defined by Calin criteria;
- •disease duration range from 6 months to 2 years;
- •BASDAI score more than 4;
- •MRI score of sacroiliac joint more than 4;
- •lab examination: hemoglobin more than 90 gram/liter. Aspartate aminotransferase and Alanine aminotransferase less than 2 fold of upper level of normal range. Creatine less than upper level of normal range.
排除标准
- •History of psoriasis or inflammatory bowel disease.
- •Intra-articular injection of cortisone within 3 months.
- •Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
- •Active iritis.
- •History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
- •Female of pregnancy or breast feeding.
- •History of mental disease and poor compliance.
- •History of drug abuse or alcoholism.
研究组 & 干预措施
infliximab
200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
干预措施: infliximab (Drug)
结局指标
主要结局
Proportion of patients achieving ASAS20 improvement.
时间窗: 6th week
次要结局
- Proportion of patients achieving ASAS50 and ASAS70(6th week and 24 week.)
研究者
Gu Jieruo
Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University