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Completed

NCT Number: NCT00554853

PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pioglitazone

Drug

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

Other names: Actos

Sublingual nitroglycerine

Drug

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.

Primary outcomes

  1. Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia

    Time frame: 8 months

    This measure represents the percentage change in diameter of brachial artery in response to reactive hyperemia. The data is presented intentionally and only for the results at the conclusion of the study.

Secondary outcomes

  1. Rheumatoid Arthritis Disease Activity

    Time frame: 8 mo

    Quantification of disease activity using validated assessments (disease activity score on 28 joints (DAS28) and and C-reactive protein ( CRP) (Inflammatory marker) as a combined score (DAS-28CRP)).

    Mean decrease in DAS-28-CRP score when compared to baseline was measured. The range of DAS-28-CRP is 0-10, with 0 meaning no active disease detected and 10 being the most severe active disease detected by joint count and C-reactive protein levels in blood.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: RAPPAR

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Nov 7, 2007
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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