CompletedNCT00679510RORAUpdated Nov 5, 2019

Rosuvastatin in Rheumatoid Arthritis (RORA)

A Phase 2/3 interventional study of rosuvastatin and placebo in Rheumatoid Arthritis, sponsored by University of Dundee. Completed at 1 site in United Kingdom. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-11-05.

Sponsored by University of Dundee · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 40 Years and older
Sex: All

Study 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.

Conditions studied

Rheumatoid Arthritis

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Keywords

Rheumatoid Arthritis
Rosuvastatin
Cardiovascular
Intima media thickness

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

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Lead sponsor

University of Dundee is the lead sponsor of 111 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: 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

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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 50 participants (actual)

Study arms

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

Interventions

Drugrosuvastatin
tablet 10 mgs once daily
Also known as: crestor
Drugplacebo
placebo

What researchers measure

Primary outcomes

measurement of intima media thickness
Time frame: 6 months

Study locations

1 site

University of Dundee
Dundee, United Kingdom

References and documents

Publications

Kumar P, Kennedy G, Khan F, Pullar T, Belch JJ. Rosuvastatin might have an effect on C-reactive protein but not on rheumatoid disease activity: Tayside randomized controlled study. Scott Med J. 2012 May;57(2):80-3. doi: 10.1258/smj.2012.012004. PubMed 22555227 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00679510
Lead sponsor: University of Dundee
Responsible party: Sponsor
First posted: May 19, 2008
Start date: Feb 2004
Primary completion: Jan 2008
Completion: Jan 2008
Last update: Nov 5, 2019

Study contacts

Jill Belch, MD FRCP

study chair · University of Dundee

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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