PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Peroxisome Proliferator-activated Receptor-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks and other complications of their blood vessels. New therapies are needed to prevent this complication. The purpose of this study is to establish the role of the medication pioglitazone in improving the function of the blood vessels and heart and decreasing the risk of future atherosclerosis development in individuals with rheumatoid arthritis. As a secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation.

This study will establish the role of pioglitazone in improvement of endothelial function, arterial compliance and disease activity in patients with rheumatoid arthritis. This will be a placebo-controlled, double blind, cross-over trial.

Two of the measures which were initially listed as separate outcome measures: (Decrease in inflammation) and Efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation are now shown as a combined score (DAS-28-CRP). The Risks or Side Effects as an outcome measure would be duplicative of the tables in the adverse event section and therefore were deleted as an outcome measure.

Inclusion Criteria:

• Women on adequate contraception if they are of child-bearing age.
• Meet revised ACR criteria for RA.
• Stable doses of DMARDS,biologic agents and or corticosteroids for at least 3 months.

Exclusion Criteria:

• Pregnant or lactating women.
• Current smokers or individuals who smoked in the last 6 months.
• Diagnosis of Diabetes, heart failure, or infection.
• Current diagnosis of malignant disease except for basal cell or squamous cell carcinoma of the skin.
• No active liver disease.
• No cholesterol-lowering medications or oral hypoglycemic agents.