Viewing Study NCT00356473



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Study NCT ID: NCT00356473
Status: COMPLETED
Last Update Posted: 2012-06-22
First Post: 2006-07-25

Brief Title: Effects of Atorvastatin on Disease Activity and HDL Cholesterol Function in Patients With Rheumatoid Arthritis
Sponsor: University of California Los Angeles
Organization: University of California Los Angeles

Study Overview

Official Title: Effects of Atorvastatin on Disease Activity and HDL Cholesterol Anti-inflammatory Properties in Patients With Rheumatoid Arthritis
Status: COMPLETED
Status Verified Date: 2006-06
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 research evaluates the effects of a cholesterol-lowering medication atorvastatin on both arthritis activity and the ability of high-density lipoprotein cholesterol HDL-C sometimes referred to as good cholesterol to prevent changes in low-density lipoprotein cholesterol LDL-C sometimes referred to as bad cholesterol which lead to atherosclerosis or hardening of the arteries We hypothesize that atorvastatin may improve both joint inflammation and the anti-inflammatory properties of HDL cholesterol
Detailed Description: Heart attacks are the leading cause of death in patients with rheumatoid arthritis RA Cardiovascular events occur more frequently than would be expected in patients with RA and traditional heart risk factors do not explain this increased risk Further research is needed to pursue ways of reducing heart disease mortality and improving outcome in patients with RA

There is reason to believe that a class of cholesterol-lowering medications called statins beneficial in cardiovascular disease prevention may be able to reduce the irritation of the joints inflammation associated with RA Statins have been shown to reduce manifestations of inflammation in the blood of patients at increased risk for heart disease and in the process reduce the risk of heart attack stroke and sudden death Some similarities in the nature of both RA and heart disease may suggest potential benefits of statin therapy in both conditions

In addition to inflammation another factor which may contribute to coronary heart disease CHD risk in RA patients is dysfunctional high-density lipoprotein cholesterol HDL-C sometimes referred to as good cholesterol Normally HDL-C acts to counter a type of damage called oxidation within LDL-C which is a critical step in the development and progression of heart disease Data from patients with RA and system lupus erythematosus SLE suggests that patients with active rheumatic diseases such as RA and SLE may have increased amounts of dysfunctional HDL-C and therefore they may be at increased risk of heart disease A blood test developed by Dr Navab and colleagues at UCLA rapidly assesses this HDL-C function This study will investigate both the level of HDL-C antioxidant function in patients with active RA as well as whether abnormal HDL function can be improved by statin use in this population This research also evaluates the effects of atorvastatin on arthritis activity We hypothesize that atorvastatin may improve both joint inflammation and the anti-inflammatory properties of HDL cholesterol

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