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

NCT00519363 | Completed Phase 1

• 5 other identifiers: 06-316SaintLuke'sHospitalGrant
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Systemic Lupus Erythematosus

Keywords

Lupus; TLR's; Hyperlipidemia; age eighteen to sixty; female with SLE; SLEDAI, greater than four; LDL cholesterol elevated

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

• lower lipid levels in female lupus patients

  3 months

Interventions

atorvastatin DRUG

atorvastatin 40mg, given orally daily for 3 months.

Also known as: Lipitor 40mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• The Center for Rheumatic Disease, Allergy, & Immunology: lead
• Saint Luke's Health System: collaborator

Study Sites (1)

The Center for Rheumatic Disease, Allergy, and Immunology

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Hyperlipidemias; Hyperlipoproteinemia Type II

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Nabih I Abdou, MD, PhD

  The Center for Rheumatic Disease, Allergy, and Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 22, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 24, 2010

Record last verified: 2009-09

Locations

US (1)