Rosuvastatin in Rheumatoid Arthritis (RORA) - Full Text View

Sponsored by:	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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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
A: Active Comparator	Drug: rosuvastatin tablet 10 mgs once daily
B: Placebo Comparator	Drug: placebo 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:	University of Dundee ( James Houston )
Study ID Numbers:	21726/0204/001-0001, 2004-001909-10
Study First Received:	May 15, 2008
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00679510 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:

Rheumatoid Arthritis
Rosuvastatin
Cardiovascular
Intima media thickness

Study placed in the following topic categories:

Antimetabolites
Rosuvastatin
Autoimmune Diseases
Musculoskeletal Diseases
Antilipemic Agents
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Anticholesteremic Agents
Rheumatic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:

Antimetabolites
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Joint Diseases
Antilipemic Agents
Arthritis, Rheumatoid
Enzyme Inhibitors
Rheumatic Diseases

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 11, 2009