Trial record 3 of 439 for:
lupus
Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
This study has been completed.
Sponsor:
The Center for Rheumatic Disease, Allergy, & Immunology
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
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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:
Detailed Description:
-
Drug: atorvastatin
atorvastatin 40mg, given orally daily for 3 months.
Other Name: Lipitor 40mg
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
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 Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013