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

This study has been completed.
Sponsor:
Collaborator:
Saint Luke's Health System
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology
ClinicalTrials.gov Identifier:
NCT00519363
First received: August 20, 2007
Last updated: March 23, 2010
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: atorvastatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.

Resource links provided by NLM:


Further study details as provided by The Center for Rheumatic Disease, Allergy, & Immunology:

Primary Outcome Measures:
  • decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9. [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • lower lipid levels in female lupus patients [ Time Frame: 3 months ]

Estimated Enrollment: 15
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: atorvastatin
    atorvastatin 40mg, given orally daily for 3 months.
    Other Name: Lipitor 40mg
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519363

Locations
United States, Missouri
The Center for Rheumatic Disease, Allergy, and Immunology
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
The Center for Rheumatic Disease, Allergy, & Immunology
Saint Luke's Health System
Investigators
Principal Investigator: Nabih I Abdou, MD, PhD The Center for Rheumatic Disease, Allergy, and Immunology
  More Information

No publications provided

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
Study First Received: August 20, 2007
Last Updated: March 23, 2010
Health Authority: United States: Institutional Review Board

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014