Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- DAS28
研究概览
简要总结
The primary hypothesis constitutes that the fish-oil preparation (Omegaven) is superior to the preparation based on Soja-oil (Lipovenös)to reduce signs and symptoms in patients with active rheumatoid arthritis.
详细描述
The study can be considered a phase III trial (comparison of two licensed preparations in a non-approved indication). This controlled double blind trial aims to compare the effect of parenterally applied fat emulsions on the disease activity of RA patients, as expressed by changes of the DAS28.
To test for the hypothesis patients are randomized and treated with 2ml/kg bodyweight of both preparations for seven consecutive days. These treatment cycles are repeated four times at monthly intervals. For not improving patients (DAS28 decrease <0.6) escapes before the third and the fourth treatment cycle are foreseen. In case of escape patients are treated with Omegaven in an open manner.
Efficacy parameters comprise the DAS28, the ACR-criteria, the M-HAQ, the SF-36, and the co-medication consumption. To assess safety laboratory parameters, comprising, LFT, KFT, CBC, fasting glucose, cholesterol, HDL, LDL, neutral fat, and urinary analysis are performed. Moreover, blood pressure control and clinically examinations are performed on a regular basis.
Study recruitment started in fall 2004 and was completed in November 2006.
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
- Double
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
- •written informed consent
- •RA according to the ACR criteria
- •active RA (DAS28 > 4.0) at the screening visit
- •insignificant DAS28-change (<0.6) between screening and the first intervention
排除标准
- •age lower than 18 yrs.
- •pregnancy and insufficient birth control
- •lactation
- •army service
- •lack of independence
- •relevant therapeutic or dietary changes during the last three months
- •relevant therapeutic or dietary changes foreseen for the study duration (including surgery)
- •application of Omega-3 fatty acids during the last three months
- •application of Omega-3 fatty acids intended for the study duration
- •prednisolone > 10 mg/day
- •contraindication for Omegaven or Lipovenös (according to the label)
研究组 & 干预措施
未命名试验
干预措施: Omegaven (10% fish-oil emulsion; Fresenius-Kabi) (Drug)
结局指标
主要结局
DAS28
次要结局
- ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption