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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00763139 |
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Date of registration:
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26/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Inflammation and Insulin Resistance in Rheumatoid Arthritis
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Scientific title:
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Inflammation and Insulin Resistance in Rheumatoid Arthritis |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00763139 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Charles M. Stein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meets the American College of Rheumatology (ACR) criteria for the diagnosis of
rheumatoid arthritis (RA)
- Stable disease activity, as evidenced by no change in immunomodulating or
anti-inflammatory therapy in the 1 month before study entry
- Moderate disease activity, as reflected by a minimum of three swollen and tender
joints
- If female of childbearing potential, willing to use effective method of contraception
Exclusion Criteria:
- Allergic to pioglitazone
- Active cancer (other than skin cancer)
- HIV infected
- Currently receiving dialysis
- Received an organ or bone marrow transplant
- Heart failure
- Severe edema, as judged by the principal investigator
- Diabetes mellitus requiring drug therapy: levels of aspartate aminotransferase (AST)
or alanine aminotransferase (ALT) greater than twice the upper limit of normal
- Underwent major surgery in the 3 months before study entry
- Severe comorbid condition that is likely to compromise survival or study participation
- Currently receiving gemfibrozil or rifampin
- Osteoporosis and not receiving osteoporosis medications
- Unwillingness, or other inability, to cooperate with study procedures
- Pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Placebo
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Drug: Pioglitazone
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Primary Outcome(s)
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Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)
[Time Frame: Measured after 8 weeks of treatment]
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Homeostasis Model Assessment (HOMA) for Insulin Sensitivity
[Time Frame: Measured after 8 weeks of treatment]
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Secondary Outcome(s)
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ESR
[Time Frame: baseline and after 8 weeks on either placebo or pioglitazone]
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C-reactive Protein (CRP)
[Time Frame: Measured after 8 weeks of treatment]
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Secondary ID(s)
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P60AR056116
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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