A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of patients with complete response
研究概览
简要总结
This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.
详细描述
In this study, 40 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized into the tofacitinib treatment group and prednisolone treatment group. Patients will follow the same reduction steps for prednisolone and its placebo. The primary end point is the percentage of patients who are in complete response at week 24.
The efficacy will be evaluated at week 4, 12 and 24. 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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;
- •Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;
- •Patients who signed the informed consent form.
排除标准
- •Patients who failed or intolerant to either tofacitinib or its similar drugs;
- •Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
- •Not well controlled diabetes;
- •Moderate and severe hyperlipedimia;
- •Patients with history of thrombus;
- •Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min);
- •Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;
- •Upper GI bleeding happened in 3 months before enrollment;
- •Refractory hypertension;
- •Pregnant or intended to be pregnant recently;
- •Severe coronary artery involvement demonstrated by CTA;
- •Severe cranial or cervical or renal artery diseases that need surgery;
- •Patients that should not be included judged by the investigator.
研究组 & 干预措施
Tofacitinib group
Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
干预措施: Tofacitinib 5 MG (Drug)
Tofacitinib group
Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
干预措施: Placebo of prednisolone (Other)
Prednisolone group
Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks
干预措施: Prednisolone (Drug)
Prednisolone group
Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks
干预措施: Placebo of tofacitinib 5mg (Other)
结局指标
主要结局
Percentage of patients with complete response
时间窗: week 24
Percentage of patients with complete response at week 24
次要结局
- Percentage of patients with adverse events due to treatment of tofacitinib(24 weeks)
- Percentage of patients with progression, no change, and improvement in vessel image at the end of study(week 24)
- Percentage of patients with partial response(week 24)
- Percentage of patients with adverse events due to treatment of prednisolone(24 weeks)
- Intervention procedures(24 weeks)
- Glucocorticoid toxicity index(week 24)
- Complication of Takayasu's arteritis(24 weeks)
研究者
Xinping Tian
Professor of Medicine
Chinese SLE Treatment And Research Group