Rosuvastatin in Rheumatoid Arthritis (RORA)

Condition(s) targeted: Rheumatoid Arthritis

Intervention: rosuvastatin (Drug); placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Dundee

Official(s) and/or principal investigator(s):
Jill Belch, MD FRCP, Study Chair, Affiliation: University of Dundee

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.

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

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

Primary outcome: measurement of intima media thickness

Secondary outcome:

blood cardiovascular surrogate markers, lipid profiles and oxidises LDL

liver function tests, creatinine kinase

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: February 2004
Ending date: January 2008
Last updated: May 15, 2008