Rosuvastatin in Rheumatoid Arthritis (RORA)

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00679510

Acronym

RORA

Enrollment

Registered

2008-05-19

Start date

2004-02-29

Completion date

2008-01-31

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Rosuvastatin, Cardiovascular, Intima media thickness

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.

Interventions

DRUGrosuvastatin

tablet 10 mgs once daily

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, 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.

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
measurement of intima media thickness	6 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026