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Effects of Atorvastatin on Disease Activity and HDL Cholesterol Function in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356473
First Posted: July 26, 2006
Last Update Posted: June 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, Los Angeles
  Purpose
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Atorvastatin on Disease Activity and HDL Cholesterol Anti-inflammatory Properties in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • HDL anti-inflammatory properties at 0 and 12 weeks [ Time Frame: at 0 and 12 weeks ]
  • Highly sensitive C-reactive protein (hs-CRP) at 0 and 12 weeks [ Time Frame: at 0 and 12 weeks ]

Secondary Outcome Measures:
  • Disease activity score using a 28 joint count (DAS28) at 0,3,6,12, and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ]
  • Patient and physician global assessments on visual analogue pain scale (VAS; 0-100) at 0,3,6,12, and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ]
  • Swollen and tender joint counts at 0,3,6,12,and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ]
  • Patient pain assessment on VAS (0-100)at 0,3,6,12, and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ]
  • Erythrocyte sedimentation rate(Westergren) at 0,3,6,12, and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ]
  • Cholesterol levels at 0,3,6,12, and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ]
  • Health assessment questionnaire disability index (HAQ-DI) at 0,3,6,12, and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ]

Enrollment: 20
Study Start Date: March 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Atorvastatin
Experimental: Atorvastatin
Atorvastatin
Drug: Atorvastatin

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356473


Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Benjamin J Ansell, MD UCLA David Geffen School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00356473     History of Changes
Other Study ID Numbers: 02-07-061-02
First Submitted: July 25, 2006
First Posted: July 26, 2006
Last Update Posted: June 22, 2012
Last Verified: June 2006

Keywords provided by University of California, Los Angeles:
Rheumatoid arthritis
Atherosclerosis
High density lipoprotein (HDL) cholesterol
Statins
HDL anti-inflammatory properties
Atorvastatin

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Atorvastatin Calcium
Anti-Inflammatory Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors