Rosuvastatin in Rheumatoid Arthritis (RORA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2008-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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rosuvastatin

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

Group Type ACTIVE_COMPARATOR

rosuvastatin

Intervention Type DRUG

tablet 10 mgs once daily

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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rosuvastatin

tablet 10 mgs once daily

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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crestor

Eligibility Criteria

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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.
* 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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No