An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.

University of South Florida74 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Conditions

Gout

Interventions

Magnetic Resonance ImagingOTHER

An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).

FebuxostatDRUG

All subjects in the sub-study will be started on febuxostat 40mg daily at baseline. If their serum urate level is \> 6.0 at months 1 or 3, then the febuxostat dose will be increased to 80mg daily.

ColchicineDRUG

Colchicine will be dosed at 0.6mg by mouth BID for the first three months then 0.6mg daily from months 3 to 6, and then discontinued at month 6.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

University of South Florida Medical Clinics

Tampa, Florida, United States

Outcomes

Primary Outcomes

Number and Percentage of Participants With Evidence of Chronic Ongoing Synovial-Based Inflammatory Disease at Baseline.

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, i.e. synovial pannus, in their "index joint", and determine if there is a correlation of the prevalence and severity of synovial pannus in the "index joint" with the patients' serum urate levels on the day of their MRI.

Time frame: MRI and baseline uric acid level will be performed upon enrollment in the study.

Secondary Outcomes

Number and Percentage of Substudy Participants for Whom the Severity of Synovial Pannus Was Significantly Reduced After 9 Months of Treatment With Febuxostat (Uloric).

A sub-study in a subgroup of patients will analyze the Number and Percentage of Substudy Participants for whom the Severity of Synovial Pannus was Significantly Reduced After 9 Months of Treatment with Febuxostat (Uloric) in the "index joint" by comparing the baseline MRI with a repeat MRI of the same joint.

Time frame: Upon enrollment into study, and at month 9.

Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.

Number of Participants with Other Characteristic Findings of Gout on these MRI's. These include erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, and soft tissue edema. These secondary endpoints will also be summed with patients' serum urate levels.

Time frame: Upon enrollment into study

Mean Serum Urate Levels for Previous 2 Years at Baseline.

Determine if there is a correlation between the prevalence and severity of synovial pannus in the "index joint" with the patients' mean serum urate level from the previous 2 years at baseline.

Time frame: previous 2 years upon enrollment into study

Data from ClinicalTrials.gov

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