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| Sponsor: | University of California, Los Angeles |
|---|---|
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00356473 |
Purpose
Heart attacks are the leading cause of death in patients with rheumatoid arthritis (RA). They occur more frequently than would be expected in patients with RA and traditional heart risk factors do not explain this increased risk.
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 as well as reduce risk of cardiovascular events. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Atorvastatin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effects of Atorvastatin on Disease Activity and HDL Cholesterol Anti-Inflammatory Properties in Patients With Rheumatoid Arthritis |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | September 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Fulfill American College of Rheumatology (ACR) criteria for RA
At least 18 years of age
Have RA for at least one year with ongoing active disease (active disease defined as at least two of three: 1) ≥ six tender joints; 2) ≥ three swollen joints; 3) ≥ 45 minutes of morning stiffness)
Taking stable doses of disease modifying anti-rheumatic drug (DMARD) therapy for at least 3 months prior to study entry -
Exclusion Criteria:
Unable to give informed consent
Pregnant or lactating
Eligible for pharmacologic lipid-lowering therapy per National Cholesterol Treatment Program Adult Treatment Panel III guidelines
Using any lipid lowering medication
Known hepatic disease
Elevated liver transaminase levels within the past two months
Previous treatment in the last three months with hydroxychloroquine
-
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00356473 History of Changes |
| Other Study ID Numbers: | 02-07-061-02 |
| Study First Received: | July 25, 2006 |
| Last Updated: | July 25, 2006 |
| Health Authority: | United States: Institutional Review Board |
|
Rheumatoid arthritis Atherosclerosis High density lipoprotein (HDL) cholesterol |
Statins HDL anti-inflammatory properties Atorvastatin |
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Anti-Inflammatory Agents Atorvastatin |
Therapeutic Uses Pharmacologic Actions Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
