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Rosuvastatin in Rheumatoid Arthritis (RORA) (RORA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679510
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : November 5, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: rosuvastatin Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Patients were randomly allocated either rosuvastatin (crestor) 10 mgs or placebo. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd. Computerised randomisation was done by an independent person from Tayside pharmacy and both patients and doctors were unaware of drug allocation. In order to blind the trial drugs during the study period, the blood tests for cholesterol were checked by research nurse who was not involved in the clinical assessment of patients.
Primary Purpose: Treatment
Official Title: Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis
Study Start Date : February 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: rosuvastatin
Rosuvastatin Patients were randomly allocated rosuvastatin (crestor) 10 mgs. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.
Drug: rosuvastatin
tablet 10 mgs once daily
Other Name: crestor

Placebo Comparator: Placebo
Placebo. Patients were randomly allocated placebo. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.
Drug: placebo

Primary Outcome Measures :
  1. measurement of intima media thickness [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00679510

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United Kingdom
University of Dundee
Dundee, United Kingdom
Sponsors and Collaborators
University of Dundee
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Study Chair: Jill Belch, MD FRCP University of Dundee
Additional Information:
Publications of Results:
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Responsible Party: University of Dundee Identifier: NCT00679510    
Other Study ID Numbers: 21726/0204/001-0001
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Dundee:
Rheumatoid Arthritis
Intima media thickness
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors