Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis - Full Text View

Sponsor:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00555230

Purpose

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 and pulse wave velocity.

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis Statins

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV. [ Time Frame: baseline,wk24,wk52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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,wk0,wk3,wk8,wk12,wk24,wk36,wk52 ] [ Designated as safety issue: Yes ]

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	Drug: Rosuvastatin 5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
2: Placebo Comparator Placebo	Drug: Placebo 5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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≥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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555230

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

No publications provided

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 History of Changes
Health Authority:	Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

HMG-CoA reductase inhibitors
Crestor
Rosuvastatin

Additional relevant MeSH terms:

Antimetabolites
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Joint Diseases
Antilipemic Agents
Arthritis, Rheumatoid
Enzyme Inhibitors
Rheumatic Diseases

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on February 08, 2010