PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease (RAPPAR)

University of Michigan

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: pioglitazone

Drug: Sublingual nitroglycerine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00554853

5R01HL086553 (U.S. NIH Grant/Contract)

HUM11806

Details and patient eligibility

About

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.

Full 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.

Enrollment

143 patients

Sex

All

Ages

21 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

143 participants in 2 patient groups

Pioglitazone then placebo

Other group

Description:

Oral daily pioglitazone 30 mg tablets daily for 2 weeks, followed by 45 mg daily tablets until end of study for 3 months compared to placebo in tablets of equal presentation for 3 months, then crossover after a 2 month washout.

Treatment:

Drug: Sublingual nitroglycerine

Drug: pioglitazone

placebo then study drug (pioglitazone)

Other group

Description:

Oral daily placebo for 3 months compared to pioglitazone for 3 months, then crossover after a 2 month washout. Similar doses as mentioned above.

Treatment:

Drug: Sublingual nitroglycerine

Drug: pioglitazone