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Rosuvastatin in Rheumatoid Arthritis (RORA) (RORA)
This study has been completed.
Sponsor:
University of Dundee
Information provided by (Responsible Party):
University of Dundee
ClinicalTrials.gov Identifier:
NCT00679510
First received: May 15, 2008
Last updated: January 7, 2016
Last verified: January 2016
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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. Endothelial behaviour improved on treatment.
| Condition | Intervention | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: rosuvastatin Drug: placebo | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Dundee:
Primary Outcome Measures:
- measurement of intima media thickness [ Time Frame: 6 months ]
Secondary Outcome Measures:
- blood cardiovascular surrogate markers, lipid profiles and oxidises LDL [ Time Frame: 6 months ]
- liver function tests, creatinine kinase [ Time Frame: 3 and 6 months ]
| Enrollment: | 50 |
| Study Start Date: | February 2004 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Rosuvastatin
|
Drug: rosuvastatin
tablet 10 mgs once daily
Other Name: crestor
|
|
Placebo Comparator: B
Placebo
|
Drug: placebo
placebo
|
Eligibility| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00679510
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | May 15, 2008 |
| Last Updated: | January 7, 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 Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on September 21, 2017