NCT00679510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

3.9 years

First QC Date

May 15, 2008

Last Update Submit

November 1, 2019

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisRosuvastatinCardiovascularIntima media thickness

Outcome Measures

Primary Outcomes (1)

  • measurement of intima media thickness

    6 months

Study Arms (2)

rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin Patients were randomly allocated rosuvastatin (crestor) 10 mgs. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.

Drug: rosuvastatin

Placebo

PLACEBO COMPARATOR

Placebo. Patients were randomly allocated placebo. The drugs (rosuvastatin and placebo) were provided by Astra Zeneca Ltd.

Drug: placebo

Interventions

rosuvastatinDRUG

tablet 10 mgs once daily

Also known as: crestor
rosuvastatin
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Dundee

Dundee, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22555227RESULT

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jill Belch, MD FRCP

    University of Dundee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

February 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)