Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: Rosuvastatin; Drug: Placebo	Phase 2

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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; Rosuvastatin	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	Drug: Placebo; 5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks; Other Name: crestor

Outcome Measures

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Primary Outcome Measures :

1. Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV. [ Time Frame: baseline,week24,week52 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China
School of Pharmacy CUHK
Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:	Edmund Kwok Ming Li, MD	Chinese University of Hong Kong

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Edumun K Li,MD, the Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00555230 History of Changes
Other Study ID Numbers:	RA-2007-004
First Posted:	November 8, 2007
Last Update Posted:	January 27, 2011
Last Verified:	December 2008

Keywords provided by Chinese University of Hong Kong:

HMG-CoA reductase inhibitors; Crestor; Rosuvastatin

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases	Rosuvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Enzyme Inhibitors