Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
Treatment with lisinopril 20 mg once daily versus placebo
Sponsors
Addenbrooke's NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rheumatoid disease activity score 28 (DAS28) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Outcome results
None listed