Trial in Rheumatoid Arthritis of Lisinopril

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN30714266
• Lead Sponsor: Addenbrooke's NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-05
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rheumatoid disease activity score 28 (DAS28)

Secondary Outcome Measures

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