CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 143 enrolled
Drug / intervention
pioglitazone +1 moredrug
Likely dose
pioglitazone 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00554853
NCT00554853Phase 3Completed

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

University of Michigan·interventional·Posted Nov 7, 2007·Updated Feb 2, 2017

In Brief

A Phase 3 clinical trial evaluating pioglitazone and Sublingual nitroglycerine for Rheumatoid Arthritis. Completed, enrolled 143 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2007
Enrollment StartNov 1, 2007
Primary CompletionOct 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.7 years ago

Interventions

pioglitazonedrug

daily dose, 30 mg daily for 2 weeks followed by 45 mg daily until completing 3 months unless higher dose not tolerated in which case patient remained at 30 mg daily

Sublingual nitroglycerinedrug

Used during nitroglycerin-mediated dilatation vascular function measures in both arms of the study if patient's blood pressure permitted. One single tablet was used per vascular test performed.