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OpenTrials
Completed

NCT Number: NCT00679510

Rosuvastatin in Rheumatoid Arthritis (RORA)

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Dundee

Dundee, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

tablet 10 mgs once daily

Other names: crestor

Placebo

Drug

placebo

Primary outcomes

  1. measurement of intima media thickness

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Official study title

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

Acronym: RORA

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
May 19, 2008
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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