Rosuvastatin in Rheumatoid Arthritis (RORA) - Full Text View

Sponsor:	University of Dundee
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00679510

Purpose

Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our study is aimed at looking at the effects of proven cholesterol lowering treatment drug called rosuvastatin in rheumatoid arthritis patients on few cardiovascular markers.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: rosuvastatin Drug: placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:

measurement of intima media thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

blood cardiovascular surrogate markers, lipid profiles and oxidises LDL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
liver function tests, creatinine kinase [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	February 2004
Study Completion Date:	January 2008
Estimated Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: rosuvastatin tablet 10 mgs once daily Other Name: crestor
Placebo Comparator: B	Drug: placebo placebo Other Name: placebo

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679510

Sponsors and Collaborators

University of Dundee

Investigators

Study Chair:

Jill Belch, MD FRCP

University of Dundee

More Information

No publications provided

Responsible Party:	James Houston, University of Dundee
ClinicalTrials.gov Identifier:	NCT00679510 History of Changes
Other Study ID Numbers:	21726/0204/001-0001, 2004-001909-10
Study First Received:	May 15, 2008
Last Updated:	May 15, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:

Rheumatoid Arthritis
Rosuvastatin
Cardiovascular
Intima media thickness

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rosuvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012