Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title: Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis

Status Completed

Clinical Trial Summary

The purpose of this study is:

1. To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA compared to healthy controls.

2. To determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness.

3. To ascertain the efficacy and safety of rosuvastatin in the prevention of atherosclerosis in patients with RA measured by carotid intima-media thickness (IMT) and pulse wave velocity (PWV).

Clinical Trial Description

150 consecutive RA patients followed at the Rheumatology clinic of the Prince of Wales Hospital will be recruited for this double-blind, randomized, placebo-control trial. Patients were matched to 150 controls on the basis of age (within 5 years), sex, body mass index (+/-5Kg) and ethnicity for the cross sectional study on the prevalence of subclinical atherosclerosis. Controls were healthy individuals recruited from the same community who underwent similar imaging protocols of the IMT and PWV assessments.

Primary outcome is the improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.

Secondary outcomes:

• Prevalence of premature atherosclerosis in RA patients compared to healthy controls in terms of the presence of plague and PWV.

• Correlation between clinical parameters, inflammatory markers (CRP/hsCRP, TNF-alpha and IL-6) and atherosclerosis (evaluated by IMT, the presence of plaque and PWV).

• Relation among PWV, ABI and AI in RA patients, and clinical significance of their combination.

• Determine which segment's PWV has a better relation with RA disease activity. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT00555230
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Status: Completed
• Phase: Phase 2
• Start date: July 2007
• Completion date: December 2009