Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Men or women, 18 years of age or older

• Clinical diagnosis of RA with a duration of at least 6 month

• Prednisolone < =10 mg/day

• NSAID or DMARD

• Informed consent

Exclusion Criteria:

• Little or no ability for self-care

• Type 1 diabetes mellitus

• Uncontrolled hypertension(> 160/95 mmHg)

• Total cholesterol > 240 mg/dl, current or recent (within the past 3 months)

• History of coronary bypass grafting, myocardial infraction within 28days, left ventricular dysfunction (ejection fraction < 40%), significant valvular heart disease

• Current treatment with ACE inhibitor, angiotensin II receptor blockers or beta-blockers, lipid lowering drug, or contra-indication to statins

• Current treatment of oral contraceptives, estrogen and progestin was allowed but patient not willing to stop during study

• Current treatment with antioxidant therapy (Vitamin C or multivitamin)

• Received intra-articular, intramuscular, or intravenous corticosteroids in the past 4 weeks before screening

• Clinically significant renal disease(serum creatinine level ≥ 270 µmol/L) or aspartate aminotransferase(AST), alanine aminotransferase ALT), or creatine kinase (CK)≥ 2 X ULN

• Female of childbearing potential, unwilling to use adequate contraception during the study

• Current or recent (within the past 3 months) pregnancy and cancer