Plain English Summary

Not provided at time of registration

Trial website

http://www.cambridge-arthritis.org.uk/tralis.php

Contact information

Type

Scientific

Primary contact

Dr Frances Hall

ORCID ID

Contact details

Box 157
Department of Clinical Medicine
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TRALIS001

Study information

Scientific title

Acronym

TRALIS

Study hypothesis

That the angiotensin converting enzyme (ACE) inhibitor, lisinopril will:
1. Reduce rheumatoid disease activity
2. Improve vascular correlates of active rheumatoid arthritis

Ethics approval

Approved by the Trent Multicentre Research Ethics Committee, provisional approval on 13/12/05, reference number: 05/MRE04/93; final approval on 01/02/06

Study design

Randomised, double-blind, placebo-controlled, dual arm study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.cambridge-arthritis.org.uk/tralis.php?name=TRALIS

Condition

Rheumatoid arthritis

Intervention

Treatment with lisinopril 20 mg once daily versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Lisinopril

Primary outcome measures

Rheumatoid disease activity score 28 (DAS28)

Secondary outcome measures

1. Swollen joint count
2. Flow-mediated dilatation (FMD)
3. Aortic pulse wave velocity (PWV)
4. Aortic augmentation index (AIx)
5. High sensitivity C-reactive protein
6. Serum cartilage oligomeric matrix protein (marker of cartilage breakdown)
7. Serum soluble intercellular adhesion molecule (ICAM-1) (marker of endothelial activation)

Overall trial start date

23/01/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥18 years and ≤80 years
2. Diagnosis of rheumatoid arthritis
3. Stable dose of disease-modifying anti-rheumatic drug (DMARD) (conventional or biological) over one month preceding the trial
4. Residual disease activity - disease activity score 28 (DAS28) >3.5
5. Use of adequate contraception in females of child-bearing potential

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Major surgery within six weeks
2. Other systemic inflammatory diseases or inflammatory arthritis (e.g. systemic lupus erythematosus [SLE], scleroderma, vasculitis, spondyloarthropathy, crystal arthropathy)
3. Functional class IV unable to mobilise without assistance from another individual or wheelchair-user
4. Treatment with another investigational agent within four weeks
5. Intra-articular or parenteral corticosteroids within four weeks of screening visit
6. Chronic use of corticosteroid >7.5 mg prednisolone (or equivalent)
7. Variation in dose of corticosteroid <7.5 mg prednisolone (or equivalent) in one month prior to screening visit
8. Current use of ACE inhibitor or angiotensin receptor blocker
9. Allergy to ACE inhibitor or angiotensin receptor blocker
10. Blood pressure (BP) ≤100/60; BP ≥180/100
11. Left ventricular failure
12. Major infective episode requiring hospitalisation or treatment with intravenous (IV) antibiotics within four weeks of screening or oral antibiotics within two weeks prior to screening
13. Current solid organ or haematological malignancy
14. Pregnancy or breastfeeding
15. Renal impairment with estimated creatinine clearance of <50 ml/min
16. Aspartate aminotranferase (AST) and alanine aminotransferase (ALT) AST/ALT >100 IU/l
17. Neutrophils <2.0 x 10^9/l, platelets <100 x 10^9/l, haemoglobin <10 g/dl
18. Known lactose intolerance

Recruitment start date

23/01/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box 157
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Addenbrooke's NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

The Evelyn Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cambridge Arthritis Research Endeavour (registered charity number: 802862)

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

Publication citations

Editorial Notes