Rosuvastatin in Rheumatoid Arthritis (RORA) (RORA)
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ClinicalTrials.gov Identifier: NCT00679510 |
Recruitment Status :
Completed
First Posted : May 19, 2008
Last Update Posted : November 5, 2019
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Condition or disease | Intervention/treatment | Phase |
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Rheumatoid Arthritis | Drug: rosuvastatin Drug: placebo | Phase 2 Phase 3 |
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 |

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.
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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.
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Drug: placebo
placebo |
- measurement of intima media thickness [ Time Frame: 6 months ]

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00679510
United Kingdom | |
University of Dundee | |
Dundee, United Kingdom |
Study Chair: | Jill Belch, MD FRCP | University of Dundee |
Publications of Results:
Responsible Party: | University of Dundee |
ClinicalTrials.gov Identifier: | NCT00679510 |
Other Study ID Numbers: |
21726/0204/001-0001 2004-001909-10 |
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 |
Rheumatoid Arthritis Rosuvastatin Cardiovascular Intima media thickness |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |