Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT00555230 |
Recruitment Status :
Completed
First Posted : November 8, 2007
Last Update Posted : January 27, 2011
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: Rosuvastatin Drug: Placebo | Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Rosuvastatin
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Drug: Rosuvastatin
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
Other Name: crestor |
Placebo Comparator: 2
Placebo
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Drug: Placebo
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
Other Name: crestor |
- Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV. [ Time Frame: baseline,week24,week52 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555230
China | |
School of Pharmacy CUHK | |
Hong Kong, China |
Principal Investigator: | Edmund Kwok Ming Li, MD | Chinese University of Hong Kong |
Responsible Party: | Edumun K Li,MD, the Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00555230 |
Other Study ID Numbers: |
RA-2007-004 |
First Posted: | November 8, 2007 Key Record Dates |
Last Update Posted: | January 27, 2011 |
Last Verified: | December 2008 |
HMG-CoA reductase inhibitors Crestor Rosuvastatin |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |