Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00519363 |
Recruitment Status
:
Completed
First Posted
: August 22, 2007
Last Update Posted
: March 24, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: atorvastatin | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors. |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | December 2008 |

-
Drug: atorvastatin
- decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9. [ Time Frame: 3 months ]
- lower lipid levels in female lupus patients [ Time Frame: 3 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519363
United States, Missouri | |
The Center for Rheumatic Disease, Allergy, and Immunology | |
Kansas City, Missouri, United States, 64111 |
Principal Investigator: | Nabih I Abdou, MD, PhD | The Center for Rheumatic Disease, Allergy, and Immunology |
Responsible Party: | Nabih I Abdou, MD, PhD, Center for Rheumatic Disease Allergy & Immunology |
ClinicalTrials.gov Identifier: | NCT00519363 History of Changes |
Other Study ID Numbers: |
06-316 Saint Luke's Hospital Grant |
First Posted: | August 22, 2007 Key Record Dates |
Last Update Posted: | March 24, 2010 |
Last Verified: | September 2009 |
Keywords provided by The Center for Rheumatic Disease, Allergy, & Immunology:
Lupus TLR's Hyperlipidemia age eighteen to sixty |
female with SLE SLEDAI, greater than four LDL cholesterol elevated |
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Atorvastatin Calcium Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |