Therapeutic Effect of Low Dose IL-2 Combined With Rapamycin in on sjögren's Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of Treg cells in peripheral blood
研究概览
简要总结
The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome
详细描述
A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, and aged 18-70 at the time of screening visit.
- •Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
- •If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
- •Disease activity: ESSDAI≥4 points.
- •The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
- •The written informed consent form approved by the Ethics Committee of Peking University People's Hospital was signed and dated by the subject or legal representative.
排除标准
- •Severe chronic liver, kidney and heart dysfunction.
- •Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
- •Patients with tumor and tumor history.
- •Chronic respiratory failure.
- •Patients who are ineffective in high-dose hormone pulse therapy.
- •Those who use rituximab or other biological agents within 3 months.
- •Patients with active tuberculosis infection or potential tuberculosis infection.
- •There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.
研究组 & 干预措施
Low-dose interleukin-2
One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks.
干预措施: low-dose interleukin-2 (Drug)
Rapamycin
Rapamycin 0.5ml once per day for 12 weeks.
干预措施: rapamycin (Drug)
Low-dose interleukin-2 and rapamycin
One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks.
干预措施: low-dose interleukin-2 (Drug)
Low-dose interleukin-2 and rapamycin
One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks.
干预措施: rapamycin (Drug)
结局指标
主要结局
Proportion of Treg cells in peripheral blood
时间窗: week 12
Proportion of Treg cells in peripheral blood will be detected by flowcytometry
次要结局
- Patient's Global Disease Activity VAS, (potential score 0 - 80)(week 12)
- Rate of Participants with adverse effects associated with experimental drugs(week 12)
- ESSDAI [potential score 0 - 123](week 12)
- Physician's Global Disease Activity VAS, (potential score 0 - 10)(week 12)
研究者
Zhanguo Li
Professor
Peking University People's Hospital