Rheumatoid Arthritis Clinical Trial
Official title:
Effects of Atorvastatin on Disease Activity and HDL Cholesterol Anti-inflammatory Properties in Patients With Rheumatoid Arthritis
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2005 |
Est. primary completion date | September 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HDL anti-inflammatory properties at 0 and 12 weeks | at 0 and 12 weeks | No | |
Primary | Highly sensitive C-reactive protein (hs-CRP) at 0 and 12 weeks | at 0 and 12 weeks | No | |
Secondary | Disease activity score using a 28 joint count (DAS28) at 0,3,6,12, and 18 weeks | at 0,3,6,12, and 18 weeks | No | |
Secondary | Patient and physician global assessments on visual analogue pain scale (VAS; 0-100) at 0,3,6,12, and 18 weeks | at 0,3,6,12, and 18 weeks | No | |
Secondary | Swollen and tender joint counts at 0,3,6,12,and 18 weeks | at 0,3,6,12, and 18 weeks | No | |
Secondary | Patient pain assessment on VAS (0-100)at 0,3,6,12, and 18 weeks | at 0,3,6,12, and 18 weeks | No | |
Secondary | Erythrocyte sedimentation rate(Westergren) at 0,3,6,12, and 18 weeks | at 0,3,6,12, and 18 weeks | No | |
Secondary | Cholesterol levels at 0,3,6,12, and 18 weeks | at 0,3,6,12, and 18 weeks | No | |
Secondary | Health assessment questionnaire disability index (HAQ-DI) at 0,3,6,12, and 18 weeks | at 0,3,6,12, and 18 weeks | No |
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