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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555230
• Other study ID #: RA-2007-004
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2007
• Last updated: January 26, 2011
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2008
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Intervention

Drug:
• Rosuvastatin
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
• Placebo
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks

Locations

Country	Name	City	State
China	School of Pharmacy CUHK	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.		baseline,week24,week52	Yes
Secondary	physical examination,blood pressure,pulse rate,and body weight measurements at each visit.Liver function and CK are performed at baseline,week 12,24 and 52.Correlation between clinical parameters,inflammatory markers and atherosclerosis.		baseline,week0,week3,week8,week12,week24,week36,week52	Yes