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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

Page last updated: August 23, 2015

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