A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ESSDAI improvement
研究概览
简要总结
A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome
详细描述
In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
- •Positive dry eyes and (or) dry mouth symptoms
- •Hyperglobulinemia
排除标准
- •Complicated with other systemic autoimmune diseases
- •Severe complications of Sjogren's syndrome
- •Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit
- •Active infections or chronic infectious diseases
- •A history of malignancies
- •Pregnancy or breathfeeding
- •Inability to comply with the study protocol for any other reason
研究组 & 干预措施
Iguratimod
Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks.
干预措施: Iguratimod (Drug)
结局指标
主要结局
ESSDAI improvement
时间窗: week 24
The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.
ESSPRI improvement
时间窗: week 24
The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.
次要结局
- SF-36(week 24)
- HAQ(week 24)
- Unstimulated salivary flow rate(week 24)
- Rheumatoid Factors(week 24)
- Schimer's test(week 24)
- Immunoglobulins(week 24)