Rosuvastatin in Rheumatoid Arthritis (RORA)

Rheumatoid Arthritis Clinical Trial

— RORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679510
• Other study ID #: 21726/0204/001-0001
• Secondary ID: 2004-001909-10
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2004
• Est. completion date: January 2008

Study information

• Verified date: November 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Dundee	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Kumar P, Kennedy G, Khan F, Pullar T, Belch JJ. Rosuvastatin might have an effect on C-reactive protein but not on rheumatoid disease activity: Tayside randomized controlled study. Scott Med J. 2012 May;57(2):80-3. doi: 10.1258/smj.2012.012004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of intima media thickness		6 months

External Links

•   Link to results paper