AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of Participants With AVN After 9 Months
研究概览
简要总结
This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. The collapse of bone may require a surgical replacement of the joint and can be disabling for life. Avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in animals. We therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids.
详细描述
If you have started on prednisone 30mg or greater and expect to be on it for greater than two weeks you may be a candidate for the study. Also, you would need to be enrolled in the study within three days of starting prednisone. If you are eligible you will receive lipitor 40mg per day or pills which look exactly like lipitor but do not contain any medication (called placebo). During the time of the study, you will not know if you are taking lipitor or the placebo. The period of time that you will receive lipitor or placebo is 9 months and you must be willing to return for 5 follow up visits during this time which include blood tests, physical exams and 3 MRI studies of the hips, knees and ankles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All individuals must fulfill 4 of the revised criteria of the American College of Rheumatology for SLE
- •Patient started on corticosteroids at a dose of at least .5mg/kg for an interval greater than two weeks
- •To be able to come for all follow-up visits for nine months
- •No contraindications to undergoing MRI
- •Age 18-75 years
排除标准
- •Evidence of liver disease, not secondary to active lupus, or liver enzyme greater than 2x normal
- •Elevated CPK at baseline
- •Pregnancy or Lactating
- •Allergy to a statin
- •Current or recent use of a statin within 3 months
研究组 & 干预措施
Placebo
Tablets identical to atorvastatin 40mg
干预措施: MRI, Venipuncture (Procedure)
Atorvastatin
Atorvastatin 40mg
干预措施: Atorvastatin (Drug)
Atorvastatin
Atorvastatin 40mg
干预措施: MRI, Venipuncture (Procedure)
Placebo
Tablets identical to atorvastatin 40mg
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With AVN After 9 Months
时间窗: 9 months
次要结局
- To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients(6 years)
- To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI)(6 years)
- Number of Participants With AVN After 4 Months(4 months)