NCT00683345已完成2 期
Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale
研究概览
简要总结
Fatigue is a prevalent phenomenon in Primary Sjøgrens syndrome (PSS). Observations indicate that the cytokine IL-1 is of importance for this phenomenon. In this study the investigators block IL-1 by giving Anakinra (an IL-1 receptor antagonist) to patients with PSS.
详细描述
A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Sjøgrens Syndrome according to the European-American criteria
- •Age 18-80 years
- •Written informed consent
排除标准
- •Hyper- og hypothyreosis
- •Malignant disease
- •Parkinsons disease
- •Multiple sclerosis
- •Conditions or diseases where Anakinra is contraindicated
- •Mental depression (BDI >13)
- •Neutropenia (<1.5*10.9)
- •Frequent infections
- •Pregnancy, lactating women.
研究组 & 干预措施
Anakinra
Active Comparator
Anakinra self-administered s.c. in a dose of 100mg daily
干预措施: Anakinra (Drug)
Placebo
Placebo Comparator
Placebo self-adminsitered s.c in a dose 0.67ml daily
干预措施: Placebo (Drug)
结局指标
主要结局
Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale
时间窗: 4 weeks
次要结局
- Inflammatory cytokines and measures of oxidative stress(4 weeks)
研究者
研究点 (1)
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