Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519363
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2007-08-20
Brief Title:
Statins and Lupus Effects of Statins on Clinical Lupus Parameters Serological Markers and Toll-like Receptors
Sponsor:
The Center for Rheumatic Disease Allergy Immunology
Organization:
The Center for Rheumatic Disease Allergy Immunology
Study Overview
Official Title:
Statins and Lupus Effects of Statins on Clinical Lupus Parameters Serological Markers and Toll-like Receptors
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 40mgday 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 SLESystemic Lupus Erythematosus disease activity and down regulates TLRToll-like receptors 24and 9 pathways in addition to lowering lipid levels
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 SLESystemic Lupus Erythematosus
Moderate to Severe disease activity using approved SLEDAISystemic Lupus Erythematosus Disease Activity Index
LDL cholesterol 100-190mgdl
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 CPKcreatine phosphakinase
already on lipid lowering therapy
already on amiodarone clarithromycin cyclosporin erythromycin itraconazole ketoconazole nefazodone verapamil protease inhibitors niacin digoxink 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 TLRsToll-like receptor in SLE patients A p value of 005 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 critera
age 18-60 females as a marjority of lupus patients are female
at least 4 ACR American College of Rheumatology criteria of SLESystemic Lupus Erythematosus
Moderate to Severe disease activity using approved SLEDAISystemic Lupus Erythematosus Disease Activity Index
LDL cholesterol 100-190mgdl
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 CPKcreatine phosphakinase
already on lipid lowering therapy
already on amiodarone clarithromycin cyclosporin erythromycin itraconazole ketoconazole nefazodone verapamil protease inhibitors niacin digoxink 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 TLRsToll-like receptor in SLE patients A p value of 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Saint | None | None | None |
| Lukes | None | None | None |
| Hospital | None | None | None |
| Grant | None | None | None |