View Clinical Trial (Medical Research Study)
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. - NCT01112982-33612(Clinical Trial 622749)
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| City: |
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Tampa |
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State:
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FL |
| Zip Code: |
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33612 |
| Conditions: |
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Gout |
| Purpose: |
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The purpose of this study is to show that patients with gout suffer from chronic
inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty
attacks. Secondary end-points of this study will include analyzing the effects of uric
acid-lowering therapy (specifically with the FDA approved medication Febuxostat) in a
subgroup of patients, checking for the presence of inflammatory markers to see if there is
any correlation with the proposed chronic inflammation, and evaluating for other
characteristic findings of gout on MRI.
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| Study summary: |
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The clinical history of untreated gout transitions from an acute intermittent arthritis to a
chronic inflammatory arthritis. This tells us that at some point the inflammation
associated with gout does not abate. Our group recently completed an advanced imaging study
in patients with early gout that suggested nearly 60% of subjects had synovial pannus during
intercritical gout. This is likely more prevalent in patients with more advanced gout. The
presence of synovial pannus also likely correlates with serum urate levels. The primary aim
of this study will be to determine the percentage of patients with known gout who have
evidence of chronic ongoing synovial-based inflammatory disease, determine the degree of
this inflammation, and correlate it with their serum urate levels. Secondary endpoints will
include assessments for the presence of other characteristic findings of gout on these MRI
(i.e. erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow
edema, and soft tissue edema). We will also be checking serum high-sensitivity CRP levels to
evaluate for any correlation with synovial pannus, and assess baseline radiographs of the
"index" joint for the presence of erosive changes, which will be correlated with the
presence and severity of synovial pannus in that same joint. Analysis will also be
performed to see if there is a correlation with serum urate levels. A sub-study will be
performed assessing the effect of aggressive serum urate lowering therapy (specifically with
febuxostat [Uloric]) on this chronic inflammation; i.e. synovial pannus. |
| Criteria: |
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Inclusion Criteria:
1. Age > or = 18 - Open ended to both males and females.
2. Have a known history of gout diagnosed by current or previous documentation of
intracellular MSU crystals in synovial fluid, a tophus proved to contain MSU
crystals, or at least six of the twelve ACR diagnostic criteria for gout (see
appendix with the 12 diagnostic criteria of gout).
3. English of Spanish speaking
4. Able to give informed consent
Exclusion Criteria:
1. Age < 18.
2. Unable to give informed consent.
3. Do not speak or write in English or Spanish.
4. History of any other inflammatory arthritis.
5. History of another crystal induced arthritis.
6. Serum creatinine >1.8 mg/dL
7. Patients taking oral corticosteroids (any dose) [or within 4 weeks]
8. Parenteral or intraarticular corticosteroids within 6 weeks
9. Allergy to gadolinium contrast dye
10. Any contraindication to receiving a MRI
11. Pregnant women
12. Allergy to febuxostat (Uloric) or colchicine [substudy subjects only] |
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| Study is available at: |
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University of South Florida Medical Clinics
Tampa, FL 33612
United States
Primary Contact:
Ernesto J Rodriguez, MD
Email: erodrig2@health.usf.edu
Phone: 813-974-2681 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
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