PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease (RA PPAR)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Peroxisome Proliferator-activated Receptor-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease|
- 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. [ Time Frame: 11/2007-7/2012 ] [ Designated as safety issue: Yes ]
- Decrease in inflammation. [ Time Frame: 8 mo ] [ Designated as safety issue: No ]By decreasing inflammation may prevent atherosclerosis and heart attacks. The study will also evaluate if pioglitazone improves the symtoms of rheumatoid arthritis.
- As a secondary outcome measure we will evaluate the efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation. [ Time Frame: 11/2007-07/2012 ] [ Designated as safety issue: No ]
- Risks or side effects to pioglitazone. [ Time Frame: 11/2007-07/2012 ] [ Designated as safety issue: Yes ]If there are adverse events during the study they are recorded and reported.
|Study Start Date:||November 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: A1
Oral daily pioglitazone for 3 months compared to placebo for 3 months, then crossover after a 2 month washout.
Other Name: Actos
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554853
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mariana J Kaplan, MD||University of Michigan|