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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:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00356473
First received: July 25, 2006
Last updated: June 21, 2012
Last verified: June 2006
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Highly sensitive C-reactive protein (hs-CRP) at 0 and 12 weeks [ Time Frame: at 0 and 12 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Swollen and tender joint counts at 0,3,6,12,and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Erythrocyte sedimentation rate(Westergren) at 0,3,6,12, and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ] [ Designated as safety issue: No ]
  • Cholesterol levels at 0,3,6,12, and 18 weeks [ Time Frame: at 0,3,6,12, and 18 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356473

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

No publications provided by University of California, Los Angeles

Additional 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
Study First Received: July 25, 2006
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

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
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

ClinicalTrials.gov processed this record on May 21, 2013