- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555230
Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis
Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis
The purpose of this study is:
- To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA compared to healthy controls.
- To determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness.
- 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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Hong Kong, China
- School of Pharmacy CUHK
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
Other Names:
|
Experimental: 1
Rosuvastatin
|
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
Time Frame: baseline,week24,week52
|
baseline,week24,week52
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: baseline,week0,week3,week8,week12,week24,week36,week52
|
baseline,week0,week3,week8,week12,week24,week36,week52
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- RA-2007-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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