An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- percentage of patients with complete response
研究概览
简要总结
This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.
详细描述
In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78.
The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18-65 years old;
- •Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;
- •relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018;
- •Patients who signed the informed consent form.
排除标准
- •Patients who failed or intolerant to either adalimumab or tofacitinib;
- •patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
- •not well controlled diabetes;
- •uncontrolled heart failure od renal dysfunction(eGFR<30ml/min);
- •Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;
- •upper GI bleeding 3 months before enrolement;
- •refractory hypertension;
- •Pregnant or intended to be pregnant 3 months after the trial;
- •Severe coronary artery involvement demonstrated by CTA;
- •severe cranial or cervical or renal artery diseases that need surgery;
- •Patients that should not be included by the investigator.
研究组 & 干预措施
Adalimumab group
Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.
干预措施: Adalimumab Injection (Drug)
Tofacitinib 5MG group
Tofacitinib 5mg BID taken orally for 78 weeks.
干预措施: Tofacitinib 5 MG (Drug)
结局指标
主要结局
percentage of patients with complete response
时间窗: week 78
percentage of patients with complete response at week 78
次要结局
- Percentage of patients with image progression at the end of study(week 78)
- intervention procedures(78 weeks)
- adverse events(78 weeks)
- percentage of patients with partial response(week 78)
研究者
Xinping Tian
Professor of Medicine
Chinese SLE Treatment And Research Group