Clinical trial NCT00555230: Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis
Official title: Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: HMG-CoA reductase inhibitors
Crestor
Rosuvastatin
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-11-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
timeFrame: baseline,week24,week52
Secondary outcomes:
measure: 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.
timeFrame: baseline,week0,week3,week8,week12,week24,week36,week52
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Pharmacy CUHK
Study officials:
affiliation: Chinese University of Hong Kong
name: Edmund Kwok Ming Li, MD
role: PRINCIPAL_INVESTIGATOR
References: