Condition category
Musculoskeletal Diseases
Date applied
14/06/2006
Date assigned
26/07/2006
Last edited
27/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dgoh.nhs.uk/tracera

Contact information

Type

Scientific

Primary contact

Dr George Kitas

ORCID ID

Contact details

Department of Rheumatology
Dudley Group of Hospitals NHS Trust
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
+44 (0)1384 244842
g.d.kitas@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis

Acronym

TRACE/RA

Study hypothesis

The principal research question is to establish whether atorvastatin, used in conjunction with standard therapy for rheumatoid arthritis will protect rheumatoid arthritis sufferers aged 40 years and above from fatal and non-fatal atherosclerotic events.

Please note that as of 30/04/2008 this trial was updated. All changes can be found in the relevant field under the above date. Please also note that the overall trial start and end dates have been updated. The previous dates of this trial were:
Previous overall trial start date: 01/12/2006
Previous overall trial end date: 01/12/2014

Ethics approval

Southampton and South West Hampshire Research Ethics Committee B, 20/12/2006, ref: 06/Q1704/171

Study design

Multicentre randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.dgoh.nhs.uk/tracera/gp_patientflyer.asp

Condition

Rheumatoid arthritis

Intervention

Patients will be randomised to either the atorvastatin arm (40 mg of atorvastatin oral tablet taken once daily) or placebo arm (placebo atorvastatin oral tablet taken once daily) of the trial.

Intervention type

Drug

Phase

Not Applicable

Drug names

Atorvastatin

Primary outcome measures

Cardiovascular primary endpoint for all patients: all cardiovascular events (analysed by time to FIRST event) briefly defined as: fatal myocardial infarction, other acute coronary heart disease death, definite or probable hospital-verified non-fatal acute myocardial infarction, resuscitated cardiac arrest, definite silent myocardial infarction verified by an electrocardiogram (ECG), coronary revascularisation procedures, hospital admission for acute coronary syndrome, fatal stroke or peripheral arterial event (using predefined standard definitions) and hospital-verified non-fatal stroke or peripheral atherosclerotic events. The endpoints assessment committee will adjudicate this.

Rheumatology primary outcome (disease activity substudy only): Disease Activity Score 28 (DAS28) at six months, response will be judged using the European League Against Rheumatism (EULAR) response criteria.

Secondary outcome measures

Secondary endpoints for all patients:
1. All-cause mortality
2. Changes in fasting lipids and C-Reactive Protein (CRP)
3. Functional outcome (assessed by the Health Assessment Questionnaire [HAQ] and EuroQoL instrument [EQ5D])
4. Statin safety-related outcomes.

Rheumatology secondary outcomes (disease activity substudy only): Disease-Modifying Anti-Rheumatic Drug (DMARD) changes, DAS28 at years one, two and five.

Not applicable as of 30/04/2008:
Radiological outcome (assessed by the Larsen score in X-rays of hands and wrists - only at year two.

Overall trial start date

07/08/2007

Overall trial end date

01/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 30/04/2008:
1. Patients must satisfy the 1987 ACR criteria for rheumatoid arthritis applied cumulatively
2. Patients must be aged more than 50 or have had RA disease duration for more than 10 years
3. Patients must provide their written informed consent

Previous inclusion criteria:
1. Patients must satisfy the 1987 ACR criteria for rheumatoid arthritis applied cumulatively
2. Patients must be 40 years or older
3. Patients must provide their written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3700 (3808 as of 30/04/2008)

Participant exclusion criteria

Current exclusion criteria as of 30/04/2008:
1. Patients who are pregnant or women of child-bearing age not using adequate contraception
2. Known primary muscle disorder
3. Known atherosclerotic disease
4. Known familial hyperlipidamia requiring drug therapy
5. Known diabetes
6. Known hypersensitivity or intolerance to statins
7. Active liver disease or hepatic dysfunction with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) more than two times Upper Limit of Normal (ULN)
8. Severe renal dysfunction (creatinine >150 micromol/l)
9. Creatinine phosphokinase (CK) more than three times ULN
10. Uncontrolled hypothyroidism (defined as any elevation of Thyroid-Stimulating Hormone [TSH] above ULN)
11. Participation in another clinical trial concurrently or within 30 days prior to screening for entry into this study (patients may be participating in an observational study such as the British Society for Rheumatology Biologics register)
12. Other serious illness or significant abnormalities that may compromise the patient's safety or successul participation in the study
13. Any illness which, in the doctor's opinion, means that the patient is unable to give informed consent
14. Known alcohol abuse

Previous exclusion criteria:
1. Patients who are pregnant or women of child-bearing age not using adequate contraception
2. Known primary muscle disorder
3. Known atherosclerotic disease
4. Known familial hyperlipidamia requiring drug therapy
5. Known diabetes
6. Calculated absolute ten year Cardio-Vascular Disease (CVD) risk of 20% or higher, using the Joint British Societies revised risk calculator
7. Known hypersensitivity or intolerance to statins
8. Active liver disease or hepatic dysfunction with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) more than two times Upper Limit of Normal (ULN)
9. Severe renal dysfunction (creatinine >150 micromol/l)
10. Creatinine phosphokinase (CK) more than three times ULN
11. Uncontrolled hypothyroidism (defined as any elevation of Thyroid-Stimulating Hormone [TSH] above ULN)
12. Participation in another clinical trial concurrently or within 30 days prior to screening for entry into this study (patients may be participating in an observational study such as the British Society for Rheumatology Biologics register)
13. Other serious illness or significant abnormalities that may compromise the patient's safety or successul participation in the study
14. Any illness which, in the doctor's opinion, means that the patient is unable to give informed consent
15. Known alcohol abuse

Recruitment start date

07/08/2007

Recruitment end date

01/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dudley Group of Hospitals NHS Trust
Dudley
DY1 2HQ
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

University Research Office
Christie Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 2227
karen.shaw@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk

Funders

Funder type

Research organisation

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

Arthritis Research Campaign (ARC) (UK) (ref: 16514)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer UK Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://rheumatology.oxfordjournals.org/content/54/suppl_1/i87.1.extract

Publication citations

Additional files

Editorial Notes