Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis
Information source: Chinese University of Hong Kong
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Rosuvastatin (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Chinese University of Hong Kong Official(s) and/or principal investigator(s):
Edmund Kwok Ming Li, MD, Principal Investigator, Affiliation: Chinese University of Hong Kong
Overall contact:
Lai-Shan Tam, MD, Phone: (852)2632-3173, Email: lstam@cuhk.edu.hk
Summary
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 and pulse
wave velocity.
Clinical Details
Official title: Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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≥270µmol/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
Locations and Contacts
Lai-Shan Tam, MD, Phone: (852)2632-3173, Email: lstam@cuhk.edu.hk
School of Pharmacy CUHK, Hong Kong, China; Recruiting
VIVIAN LEE, Phone: (852)2609-6860, Email: pharmacy@cuhk.edu.hk
Additional Information
Starting date: July 2007
Ending date: December 2009
Last updated: April 2, 2008
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