Trial in rheumatoid arthritis of lisinopril (TRALIS) - TRALIS

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Age =18 y and = 80y

Diagnosis of RA consistent with the revised ACR criteria [26].

Stable dose of Disease-modifying anti-rheumatic drug (DMARD) (conventional or biological) over preceding 1 month.

Residual disease activity: DAS28 > 3.5

Use of adequate contraception in females, if sexually active and of reproductive age (< 50y).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Major surgery within 6 weeks
2. Other systemic inflammatory diseases or inflammatory arthrtides, (e.g. 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 > 7.5mg prednisolone (or equivalent)
7. Variation in dose of corticosteroid < 7.5 mg prednisolone (or equivalent) in 1 month prior to screening visit.
7. Current use of ACE inhibitor OR angiotensin receptor blocker
8. Allergy to ACE inhibitor or angiotensin receptor blocker
9. Blood pressure BP = 100/60; BP = 180/100
10. Left Ventricular Failure
11. Major infective episode requiring hospitalisation or treatment with IV antibiotics within 4 weeks of screening OR oral antibiotics within 2 weeks prior to screening.
12. CURRENT solid organ or haematological malignancy
13. Pregnancy or breastfeeding
14. Renal impairment with estimated creatinine clearance of < 50 ml/min
15. AST/ALT > 100 IU/L
16. Neutrophils < 2.0 x 109/L, Plts < 100 x 109/L, Hb < 10 g/dl
17. Known lactose intolerance

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if lisinopril reduces the activity of rheumatoid arthritis, as measured by the validated disease activity score (DAS) 28;<br> Secondary Objective: To assess the effect of lisinopril on<br> objective measures of inflammation<br> endothelial cell dysfunction<br> aortic stiffness<br> cartilage breakdown<br> ;Primary end point(s): DAS28 (validated disease activity score in RA )

Secondary Outcome Measures

Name	Time	Method

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