Rosuvastatin in Rheumatoid Arthritis (RORA) (RORA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
rosuvastatin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Rosuvastatin, Cardiovascular, Intima media thickness
Eligibility 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.
Sites / Locations
- University of Dundee
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
rosuvastatin
Placebo
Arm Description
Rosuvastatin Patients were randomly allocated rosuvastatin (crestor) 10 mgs. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.
Placebo. Patients were randomly allocated placebo. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.
Outcomes
Primary Outcome Measures
measurement of intima media thickness
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00679510
Brief Title
Rosuvastatin in Rheumatoid Arthritis (RORA)
Acronym
RORA
Official Title
Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Dundee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Rosuvastatin, Cardiovascular, Intima media thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Patients were randomly allocated either rosuvastatin (crestor) 10 mgs or placebo. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd. Computerised randomisation was done by an independent person from Tayside pharmacy and both patients and doctors were unaware of drug allocation. In order to blind the trial drugs during the study period, the blood tests for cholesterol were checked by research nurse who was not involved in the clinical assessment of patients.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rosuvastatin
Arm Type
Active Comparator
Arm Description
Rosuvastatin Patients were randomly allocated rosuvastatin (crestor) 10 mgs. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo. Patients were randomly allocated placebo. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Other Intervention Name(s)
crestor
Intervention Description
tablet 10 mgs once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
measurement of intima media thickness
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Belch, MD FRCP
Organizational Affiliation
University of Dundee
Official's Role
Study Chair
Facility Information:
Facility Name
University of Dundee
City
Dundee
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22555227
Citation
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.
Results Reference
result
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Rosuvastatin in Rheumatoid Arthritis (RORA)
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