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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Mariana Kaplan, University of Michigan
ClinicalTrials.gov Identifier:
NCT00554853
First received: November 6, 2007
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: pioglitazone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Peroxisome Proliferator-activated Receptor-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The primary goal of the project is to evaluate the efficacy of pioglitazone a PPAR-gamma agonist, in improving markers of endothelial dysfunction and atherosclerosis risk in rheumatoid arthritis. [ Time Frame: 11/2007-7/2012 ] [ Designated as safety issue: Yes ]
  • Decrease in inflammation. [ Time Frame: 8 mo ] [ Designated as safety issue: No ]
    By decreasing inflammation may prevent atherosclerosis and heart attacks. The study will also evaluate if pioglitazone improves the symtoms of rheumatoid arthritis.


Secondary Outcome Measures:
  • As a secondary outcome measure we will evaluate the efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation. [ Time Frame: 11/2007-07/2012 ] [ Designated as safety issue: No ]
  • Risks or side effects to pioglitazone. [ Time Frame: 11/2007-07/2012 ] [ Designated as safety issue: Yes ]
    If there are adverse events during the study they are recorded and reported.


Enrollment: 144
Study Start Date: November 2007
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A1
Oral daily pioglitazone for 3 months compared to placebo for 3 months, then crossover after a 2 month washout.
 Drug: pioglitazone
daily dose
Other Name: Actos

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554853

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
Principal Investigator: Mariana J Kaplan, MD University of Michigan
  More Information

No publications provided

Responsible Party: Mariana Kaplan, Associate Proffessor, University of Michigan
ClinicalTrials.gov Identifier: NCT00554853     History of Changes
Other Study ID Numbers: HUM11806, RO1HL086553
Study First Received: November 6, 2007
Last Updated: January 17, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013