PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Rheumatoid Arthritis Clinical Trial

— RA PPAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554853
• Other study ID #: HUM11806
• Secondary ID: RO1HL086553
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2007
• Last updated: January 17, 2013
• Start date: November 2007
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Cardiovascular Diseases
• Rheumatoid Arthritis

Intervention

Drug:
• pioglitazone
daily dose

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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