NCT00555230

Brief Summary

The purpose of this study is:

  1. 1.To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA compared to healthy controls.
  2. 2.To determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness.
  3. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jul 2007

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 27, 2011

Status Verified

December 1, 2008

Enrollment Period

2.4 years

First QC Date

November 7, 2007

Last Update Submit

January 26, 2011

Conditions

Rheumatoid Arthritis

Keywords

HMG-CoA reductase inhibitorsCrestorRosuvastatin

Outcome Measures

Primary Outcomes (1)

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

    baseline,week24,week52

Secondary Outcomes (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.

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

Study Arms (2)

1

EXPERIMENTAL

Rosuvastatin

Drug: Rosuvastatin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RosuvastatinDRUG

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

Also known as: crestor
1
PlaceboDRUG

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

Also known as: crestor
2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Pharmacy CUHK

Hong Kong, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Edmund Kwok Ming Li, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 8, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 27, 2011

Record last verified: 2008-12

Locations

CN(1)