Rheumatoid arthritis
Conditions
Interventions
Trade Name: Lisinopril
Product Name: Lisinopril
Product Code: N/A
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo:
Sponsors
Research and Development Department, Addenbrookes NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 100 IU/L 16. Neutrophils < 2.0 x 109/L, Plts < 100 x 109/L, Hb < 10 g/dl 17. Known lactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if lisinopril reduces the activity of rheumatoid arthritis, as measured by the validated disease activity score (DAS) 28; Secondary Objective: To assess the effect of lisinopril on objective measures of inflammation endothelial cell dysfunction aortic stiffness cartilage breakdown ;Primary end point(s): DAS28 (validated disease activity score in RA ) | — |
Countries
United Kingdom
Outcome results
None listed