Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

NCT ID: NCT00555230

Last Updated: 2011-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-12-31

Brief 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).

Detailed 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Rosuvastatin

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks

Interventions

Rosuvastatin

5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks

Intervention Type: DRUG

Placebo

5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks

Intervention Type: DRUG

Other Intervention Names

crestor; crestor

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

the Chinese University of Hong Kong

Principal Investigators

Edmund Kwok Ming Li, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

School of Pharmacy CUHK

Hong Kong, , China

Countries

China

Other Identifiers

RA-2007-004

Identifier Type: -

Identifier Source: org_study_id