An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
Information source: University of South Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gout
Intervention: Magnetic Resonance Imaging (Other); Plain Radiographs (Other); Febuxostat (Drug); Colchicine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of South Florida Official(s) and/or principal investigator(s):
Ernesto J Rodriguez, MD, Study Director, Affiliation: University Of South Florida, Department of Rheumatology
John D Carter, MD, Principal Investigator, Affiliation: University Of South Florida, Department of Rheumatology
Summary
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.
Clinical Details
Official title: Shifting the Paradigm of Gout: An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Presence of synovial pannus in index joint.
Secondary outcome: Effect of urate-lowering therapy (specifically with febuxostat [Uloric]) on synovial pannus.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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]
Locations and Contacts
University of South Florida Medical Clinics, Tampa, Florida 33612-4742, United States
Additional Information
Medline Plus: Gout Medline Plus: Febuxostat Medline Plus: Colchicine Medline Plus: MRI
Starting date: May 2010
Last updated: July 17, 2015
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