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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00555230 |
The purpose of this study is:
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Rosuvastatin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis |
Estimated Enrollment: | 150 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Rosuvastatin
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Drug: Rosuvastatin
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
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2: Placebo Comparator
Placebo
|
Drug: Placebo
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
|
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:
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | the Chinese University of Hong Kong ( Edumun K Li,MD ) |
Study ID Numbers: | RA-2007-004 |
Study First Received: | November 7, 2007 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00555230 |
Health Authority: | Hong Kong: Department of Health |
HMG-CoA reductase inhibitors Crestor Rosuvastatin |
Rosuvastatin Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Disease Progression Arthritis, Rheumatoid Rheumatic Diseases |
Antimetabolites Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |