Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
NCT00519363 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2010-03-24
Summary
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.
Conditions
Interventions
- DRUG
-
atorvastatin 40mg, given orally daily for 3 months.
Sponsors & Collaborators
-
Saint Luke's Health System
collaborator OTHER -
The Center for Rheumatic Disease, Allergy, & Immunology
lead OTHER
Principal Investigators
-
Nabih I Abdou, MD, PhD · The Center for Rheumatic Disease, Allergy, and Immunology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-30
- Primary Completion
- 2008-10-31
- Completion
- 2008-12-31
Countries
- United States
Study Locations
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