Rosuvastatin in Rheumatoid Arthritis (RORA)

University of Dundee

Status and phase

Completed

Phase 3

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: placebo

Drug: rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00679510

2004-001909-10

21726/0204/001-0001

Details and patient eligibility

About

Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. The investigator's study is aimed at looking at the effects of proven cholesterol lowering treatment drug called rosuvastatin in rheumatoid arthritis patients on few cardiovascular markers. Endothelial behaviour improved on treatment.

Enrollment

50 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.