Rheumatoid Arthritis Clinical Trial
— RA PPAROfficial title:
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | January 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary goal of the project is to evaluate the efficacy of pioglitazone a PPAR-gamma agonist, in improving markers of endothelial dysfunction and atherosclerosis risk in rheumatoid arthritis. | 11/2007-7/2012 | Yes | |
Primary | Decrease in inflammation. | By decreasing inflammation may prevent atherosclerosis and heart attacks. The study will also evaluate if pioglitazone improves the symtoms of rheumatoid arthritis. | 8 mo | No |
Secondary | As a secondary outcome measure we will evaluate the efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation. | 11/2007-07/2012 | No | |
Secondary | Risks or side effects to pioglitazone. | If there are adverse events during the study they are recorded and reported. | 11/2007-07/2012 | Yes |
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