Official Title: “AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial”

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 atorvastatin 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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Study Primary Completion Date: January 2008

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 atorvastatin (lipitor) 40mg per day or pills which look exactly like atorvastatin 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 atorvastatin 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.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
• Procedure: MRI, Venipuncture

Primary Measures

• A goal of 50% reduction of new AVN with atorvastatin assuming 50% of patients will develop at least one new site of AVN

Secondary Measures

• To determine if atorvastatin is effective in lowering serum lipid levels Chol, TG, HDL, & LDL in SLE patients
• 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)

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: New York University School of Medicine

Overall Clinical Trial Officials and Contacts

Howard M Belmont, M.D. Principal Investigator The New York University Hospital for Joint Diseases  

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00412841

Study ID Number: H-8795

ClinicalTrials.gov Identifier: NCT00412841

Health Authority: United States: Institutional Review Board