Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
Completed · Phase 1/Phase 2
Conditions studied: Systemic Lupus Erythematosus
In brief
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.
Key facts
- Study ID
- NCT00519363
- Run by
- The Center for Rheumatic Disease, Allergy, & Immunology
- People needed
- 15
- Starts
- 2007-09-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2010-03-24
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-60, female
- have at least four ACR criteria for SLE
- SLEDAI score > 4
- LDL cholesterol level from 100-190mg/dl
You may not qualify if…
- 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
Where it is running
- The Center for Rheumatic Disease, Allergy, and Immunology — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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