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

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.
 
ClinicalTrials.gov Identifier: NCT00356473
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : June 22, 2012
Sponsor:
Information provided by:
University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE July 25, 2006
First Posted Date  ICMJE July 26, 2006
Last Update Posted Date June 22, 2012
Study Start Date  ICMJE March 2003
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2006)
  • HDL anti-inflammatory properties at 0 and 12 weeks
  • Highly sensitive C-reactive protein (hs-CRP) at 0 and 12 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2006)
  • Disease activity score using a 28 joint count (DAS28) 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
  • Swollen and tender joint counts at 0,3,6,12,and 18 weeks
  • Patient pain assessment on VAS (0-100)at 0,3,6,12, and 18 weeks
  • Erythrocyte sedimentation rate(Westergren) at 0,3,6,12, and 18 weeks
  • Cholesterol levels at 0,3,6,12, and 18 weeks
  • Health assessment questionnaire disability index (HAQ-DI) at 0,3,6,12, and 18 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Atorvastatin on Disease Activity and HDL Cholesterol Function in Patients With Rheumatoid Arthritis
Official Title  ICMJE Effects of Atorvastatin on Disease Activity and HDL Cholesterol Anti-inflammatory Properties in Patients With Rheumatoid Arthritis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: Atorvastatin
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Atorvastatin
  • Experimental: Atorvastatin
    Atorvastatin
    Intervention: Drug: Atorvastatin
Publications * Charles-Schoeman C, Khanna D, Furst DE, McMahon M, Reddy ST, Fogelman AM, Paulus HE, Park GS, Gong T, Ansell BJ. Effects of high-dose atorvastatin on antiinflammatory properties of high density lipoprotein in patients with rheumatoid arthritis: a pilot study. J Rheumatol. 2007 Jul;34(7):1459-64. Epub 2007 Jun 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2006)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00356473
Other Study ID Numbers  ICMJE 02-07-061-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin J Ansell, MD UCLA David Geffen School of Medicine
PRS Account University of California, Los Angeles
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP