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NCT Number: NCT00519363

Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors

This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9 pathways in addition to lowering lipid levels.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Immune System Diseases Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lupus Erythematosus, Systemic Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Center for Rheumatic Disease, Allergy, and Immunology

Kansas City, Missouri, 64111, United States

About this study

Atorvastin (Lipitor) is a commonly used drug approved by the FDA for treatment of dyslipidemias. It is a relatively safe drug to use with periodic monitoring.

Eligibility critera:

  • age 18-60, females, as a marjority of lupus patients are female
  • at least 4 ACR (American College of Rheumatology) criteria of SLE(Systemic Lupus Erythematosus)
  • Moderate to Severe disease activity using approved SLEDAI(Systemic Lupus Erythematosus Disease Activity Index)
  • LDL cholesterol 100-190mg/dl

Exclusion criteria

  • Pregnancy, and or lactating or wants to get pregnant
  • Unable to take atorvastatin due to allergy, liver disease, elevated liver functions, myositis, or elvated CPK(creatine phosphakinase)
  • already on lipid lowering therapy
  • already on amiodarone, clarithromycin, cyclosporin, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin,k cholestyramine, colestipol
  • has a dianosis of Myositis. Our goal is to colledt preliminary data to see if there is a trend for the efficacy of atorvastatin in ameliorating SLE disease activity and to evaluate TLRs(Toll-like receptor) in SLE patients. A p value of <0.05 will be considered statistically significant. Our baseline and at subsequent visits, we will have 80% power to detect a minimum of 34%-39% difference for most of the continous variables measured at different intervals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-60, female
  • have at least four ACR criteria for SLE
  • SLEDAI score > 4
  • LDL cholesterol level from 100-190mg/dl

Exclusion criteria

  • Pregnant, lactating, or wanting to become pregnant
  • unable to take atorvastatin due to allergy, liver disease, elevated lever function test, myositis, or eleveated CPK
  • already on lipid lowering therapy
  • participating in another lupus study
  • on drugs such as: amiodarone, clarithromycin, clclosporine, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin, cholestryrmine, colestipol
  • has a diagnosis of myositis

Treatment and study plan

atorvastatin

Drug

atorvastatin 40mg, given orally daily for 3 months.

Other names: Lipitor 40mg

Primary outcomes

  1. decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9.

    Time frame: 3 months

Secondary outcomes

  1. lower lipid levels in female lupus patients

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

The Center for Rheumatic Disease, Allergy, & Immunology

Other

Collaborators

  • Saint Luke's Health System

Registry information

Official study title

Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2007
Registry last updated
Mar 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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