Rosuvastatin in Rheumatoid Arthritis (RORA)

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: placebo; Drug: rosuvastatin

• Registration Number: NCT00679510
• Lead Sponsor: University of Dundee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo. Patients were randomly allocated placebo. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.
rosuvastatin	rosuvastatin	Rosuvastatin Patients were randomly allocated rosuvastatin (crestor) 10 mgs. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.

Primary Outcome Measures

Name	Time	Method
measurement of intima media thickness	6 months

Trial Locations

Locations (1)

University of Dundee; 🇬🇧 Dundee, United Kingdom