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Rosuvastatin in Rheumatoid Arthritis (RORA) (RORA)

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ClinicalTrials.gov Identifier: NCT00679510
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
University of Dundee

Tracking Information
First Submitted Date  ICMJE May 15, 2008
First Posted Date  ICMJE May 19, 2008
Last Update Posted Date January 8, 2016
Study Start Date  ICMJE February 2004
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
measurement of intima media thickness [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00679510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
  • blood cardiovascular surrogate markers, lipid profiles and oxidises LDL [ Time Frame: 6 months ]
  • liver function tests, creatinine kinase [ Time Frame: 3 and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rosuvastatin in Rheumatoid Arthritis (RORA)
Official Title  ICMJE Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: rosuvastatin
    tablet 10 mgs once daily
    Other Name: crestor
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: A
    Rosuvastatin
    Intervention: Drug: rosuvastatin
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2008)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00679510
Other Study ID Numbers  ICMJE 21726/0204/001-0001
2004-001909-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party University of Dundee
Study Sponsor  ICMJE University of Dundee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jill Belch, MD FRCP University of Dundee
PRS Account University of Dundee
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP