Phase 3
N=143
PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00554853 ↗Enrolled (actual)
143
Serious AEs
3.5%
Results posted
Feb 2017
Primary outcome: Primary: Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia — 8.3; 9.43 % changes in diameter of artery
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pioglitazone (Drug); Sublingual nitroglycerine (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Oct 2012
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 |
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 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). 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.