Trial in Rheumatoid Arthritis of Lisinopril
| ISRCTN | ISRCTN30714266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30714266 |
| Secondary identifying numbers | TRALIS001 |
- Submission date
- 19/12/2005
- Registration date
- 05/04/2006
- Last edited
- 14/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Frances Hall
Scientific
Scientific
Box 157
Department of Clinical Medicine
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled dual-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.cambridge-arthritis.org.uk/tralis.php?name=TRALIS |
| Scientific title | Trial in Rheumatoid Arthritis of Lisinopril |
| Study acronym | TRALIS |
| Study objectives | That the angiotensin converting enzyme (ACE) inhibitor, lisinopril will: 1. Reduce rheumatoid disease activity 2. Improve vascular correlates of active rheumatoid arthritis |
| Ethics approval(s) | Trent Multicentre Research Ethics Committee, 01/02/2006, ref: 05/MRE04/93 |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Treatment with lisinopril 20 mg once daily versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lisinopril |
| Primary outcome measure | 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 study start date | 23/01/2006 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/01/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Addenbrooke's NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
"ROR" |
https://ror.org/055vbxf86 |
|---|
Funders
Funder type
Charity
The Evelyn Trust
No information available
Cambridge Arthritis Research Endeavour (registered charity number: 802862)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/06/2017: No publications found in PubMed, verifying study status with principal investigator.
