PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Phase

Condition

Arthritis And Arthritic Pain

Vascular Diseases

Rheumatoid Arthritis

Treatment

N/A

Clinical Study ID

NCT00554853

HUM11806

5R01HL086553

Ages 21-100
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 cellcarcinoma of the skin.
No active liver disease.
No cholesterol-lowering medications or oral hypoglycemic agents.

Study Design

November 01, 2007

January 31, 2013

Study Description

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.

Connect with a study center

University of Michigan
Ann Arbor, Michigan 48109
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.