PPAR-Gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease - Full Text View

Sponsors and Collaborators:	University of Michigan National Institutes of Health (NIH)
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00554853

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: pioglitazone	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Peroxisome Proliferator-Activated Receptor-Gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	144
Study Start Date:	November 2007
Estimated Study Completion Date:	July 2012

Arms	Assigned Interventions
A1: Placebo Comparator Oral daily pioglitazone for 3 months compared to placebo for 3 months, then crossover after a 2 month washout.	Drug: pioglitazone daily dose

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554853

Contacts

Contact: Rita P Hench, BS,CCRC

734-998-7045

rhench@umich.edu

Locations

United States, Michigan
University of Michigan Research Center	Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Rita P Hench, BS,CCRC 734-998-7048 rhench@umich.edu

Sponsors and Collaborators

University of Michigan

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Mariana J Kaplan, MD

University of Michigan

More Information

Study ID Numbers:	HUM11806, RO1HL086553
Study First Received:	November 6, 2007
Last Updated:	November 6, 2007
ClinicalTrials.gov Identifier:	NCT00554853
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Pioglitazone
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009