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Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Rosuvastatin

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring HMG-CoA reductase inhibitors, Crestor, Rosuvastatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

School of Pharmacy CUHK

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Rosuvastatin

Placebo

Outcomes

Primary Outcome Measures

Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.

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.

Full Information

NCT ID

NCT00555230

First Posted

November 7, 2007

Last Updated

January 26, 2011

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00555230

Brief Title

Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

Official Title

Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

HMG-CoA reductase inhibitors, Crestor, Rosuvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Rosuvastatin

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

crestor

Intervention Description

5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

crestor

Intervention Description

5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks

Primary Outcome Measure Information:

Title

Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.

Time Frame

baseline,week24,week52

Secondary Outcome Measure Information:

Title

Time Frame

baseline,week0,week3,week8,week12,week24,week36,week52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edmund Kwok Ming Li, MD

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Pharmacy CUHK

City

Hong Kong

Country

China

12. IPD Sharing Statement

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Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

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