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Rosuvastatin in Rheumatoid Arthritis (RORA) (RORA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00679510
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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. Endothelial behaviour improved on treatment.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: rosuvastatin Drug: placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis
Study Start Date : February 2004
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Rosuvastatin
Drug: rosuvastatin
tablet 10 mgs once daily
Other Name: crestor
Placebo Comparator: B
Placebo
Drug: placebo
placebo


Outcome Measures

Primary Outcome Measures :
  1. measurement of intima media thickness [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. blood cardiovascular surrogate markers, lipid profiles and oxidises LDL [ Time Frame: 6 months ]
  2. liver function tests, creatinine kinase [ Time Frame: 3 and 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679510


Locations
United Kingdom
University of Dundee
Dundee, United Kingdom
Sponsors and Collaborators
University of Dundee
Investigators
Study Chair: Jill Belch, MD FRCP University of Dundee
More Information

Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT00679510     History of Changes
Other Study ID Numbers: 21726/0204/001-0001
2004-001909-10
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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 Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors