Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment？
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- Lesion progression
研究概览
简要总结
Currently, the traditional disease activity of Takayasu arteritis is mainly based on National Institutes of Health criteria and the inactive cases don't need anti-inflammatory treatment. However, pathologic findings showed that there was still inflammatory activity in the affected vessels, and the follow-up data also found significant lesion progression in some inactive cases. Sixty inactive Takayasu arteritis patients will be recruited to determine whether these individuals are active by screening new inflammatory markers in this study. New inflammatory markers included tumor necrosis factor,interleukin-2,interleukin-6,interleukin-8,interleukin-10,high-sensitivity C-reactive protein, and 18f-FDG positron emission tomograph. According to new inflammatory markers, sixty patients will be divided into two categories: inactive patients (n=20) and active patients (n=40). And then, Forty active patients diagnosed by new inflammatory markers will be randomly assigned to either anti-inflammatory therapy group or control group. The changes of inflammatory activity and lesion progression will be observed during one-year follow up in all 60 patients.
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
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria;
- •Inactive Takayasu arteritis according to National Institutes of Health criteria;
- •Age ≥ 14 and ≤ 40 years old at the time of informed consent;
- •Patients or guardian agree to participate in the study.
排除标准
- •Active Takayasu arteritis according to National Institutes of Health criteria;
- •Poor compliance, intolerance to or poor response to hormone therapy;
- •Allergy to contrast agent;
- •Renal insufficiency (serum creatinine >133μmol/L), cardiac insufficiency (NYHA functional class III and IV) or abnormal liver function (Alanine transaminase >1.5 times upper limit of normal)
研究组 & 干预措施
Anti-inflammatory treatment group
Prednisone and/or cyclophosphamide
干预措施: Prednisone, cyclophosphamide (Drug)
结局指标
主要结局
Lesion progression
时间窗: baseline and 12 months
Progression of previous lesion degree\>20% or new lesion
次要结局
- Changes in plasma concentration of interleukin-10(baseline, 3 months, 6 months, 9 months and 12 months)
- Changes in plasma concentration of tumor necrosis factor(baseline, 3 months, 6 months, 9 months and 12 months)
- Changes in plasma concentration of interleukin-2(baseline, 3 months, 6 months, 9 months and 12 months)
- Lesion progression(baseline, 3 months, 6 months, 9 months)
- Changes in plasma concentration of interleukin-6(baseline, 3 months, 6 months, 9 months and 12 months)
- Changes in plasma concentration of interleukin-8(baseline, 3 months, 6 months, 9 months and 12 months)
- Changes in plasma concentration of high-sensitivity C-reactive protein(baseline, 3 months, 6 months, 9 months and 12 months)
- Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph(baseline, 3 months, 6 months, 9 months and 12 months)
研究者
Xiongjing Jiang
Professor
Chinese Academy of Medical Sciences, Fuwai Hospital