Rheumatoid Arthritis Clinical Trial
Official title:
Inflammation and Insulin Resistance in Rheumatoid Arthritis
Verified date | November 2014 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness, and loss of function in the joints. Over time, joint deformity, joint destruction, and loss of function can occur. Current treatment aims to improve symptoms, but there is no cure for the disease. Pioglitazone is drug that is effective in treating people with diabetes. This study will determine whether pioglitazone can also be used to effectively treat people with RA.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 2013 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt Clinical Research Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Ormseth MJ, Oeser AM, Cunningham A, Bian A, Shintani A, Solus J, Tanner S, Stein CM. Peroxisome proliferator-activated receptor ? agonist effect on rheumatoid arthritis: a randomized controlled trial. Arthritis Res Ther. 2013;15(5):R110. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Activity Score Based on 28-joint Disease Activity Score (DAS28) | A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH | Measured after 8 weeks of treatment | No |
Primary | Homeostasis Model Assessment (HOMA) for Insulin Sensitivity | Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose * Insulin/22/5 | Measured after 8 weeks of treatment | No |
Secondary | C-reactive Protein (CRP) | Measured after 8 weeks of treatment | No | |
Secondary | ESR | sed rate | baseline and after 8 weeks on either placebo or pioglitazone | No |
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