A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks.
研究概览
简要总结
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome
详细描述
NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of Sjögren 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
- •Diagnosis of a primary Sjögren´s Syndrome
- •Liver values above 1,5 ULN
- •uncontrolled arterial hypertension
- •intraarticular or systemic use of Glucocorticoids in the last 4 weeks before
- •begin with Study medication
排除标准
- •pre-treatment with Cyclosporine A
- •Infection
- •Neoplasia
- •relevant cardiac, pulmonary, neurologic or psychiatric disease
- •life-Vaccination within 4 weeks before begin with study medication
- •pregnant or breast-feeding
- •weight under 45kg or more than 110kg
研究组 & 干预措施
Cyclosporine A
All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks
干预措施: Cyclosporine A (Drug)
结局指标
主要结局
Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks.
时间窗: 16 weeks
次要结局
- Evaluation of the safety (type and number of adverse events and serious adverse events) of low-dose Cyclosporine A in patients with primary Sjögren Syndrome(28 weeks)
研究者
Eugen Feist
PD. Dr. med. Eugen Feist
Charite University, Berlin, Germany