Official Title: “Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis”

Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our study is aimed at looking at the effects of proven cholesterol lowering treatment drug called rosuvastatin in rheumatoid arthritis patients on few cardiovascular markers.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2006

Intervention(s) in this Clinical Trial

• Drug: rosuvastatin
  • tablet 10 mgs once daily
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Placebo Comparator: B

Primary Measures

• measurement of intima media thickness
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• blood cardiovascular surrogate markers, lipid profiles and oxidises LDL
  • Time Frame: 6 months
    Safety Issue?: No
• liver function tests, creatinine kinase
  • Time Frame: 3 and 6 months
    Safety Issue?: Yes

Inclusion Criteria:

• Patients will be selected from a high risk population of hospital clinic attendees, defined as RA greater than 5 years' disease duration, and all will be RA latex seropositive or IgM RF ELISA >14iu/ml. The subjects will be of either sex and >40 years of age.
• Patients should have both tender and swollen joint counts >4 each and either a CRP
• >10mg/l, ESR >25mm/h or PV >1.78.
• Patients on cyclosporine or other medications known to be contraindicated with this form of drug will not be enrolled.

Exclusion Criteria:

• The patient's hospital and general practice records will be scrutinised for evidence of symptomatic vascular disease.
• Any patient not free from vascular disease symptoms will be excluded.
• In addition to evidence of symptomatic vascular disease (either previous or current), the exclusion criteria consist also of those already taking lipid-lowering therapy or those with contraindications to these therapies.
• Also excluded will be subjects with a total cholesterol level of >7.5mmol/L as it might be argued that such patients merit primary prevention on the basis of dyslipidemia alone.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Dundee

Overall Clinical Trial Officials and Contacts

Jill Belch, MD FRCP Study Chair University of Dundee  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00679510

Study ID Number: 21726/0204/001-0001

ClinicalTrials.gov Identifier: NCT00679510

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency