Phase 3
Completed N=143
PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease
Source: ClinicalTrials.gov NCT00554853 ↗Enrolled (actual)
143
Serious AEs
3.5%
Results posted
Feb 2017
Primary outcomePrimary: Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia — 8.3; 9.43 % changes in diameter of artery
◆ Published Evidence
Established
71citations · ~5 / year
The peroxisome proliferator activated receptor-γ pioglitazone improves vascular function and decreases disease activity in patients with rheumatoid arthritis.
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.
Linked Publications
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The peroxisome proliferator activated receptor-γ pioglitazone improves vascular function and decreases disease activity in patients with rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia |
8.3; 9.43 | — |
| SECONDARY Rheumatoid Arthritis Disease Activity |
0.15; .31 | 0.63 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00554853) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.