At a glance
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Shifting the Paradigm of Gout: An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
In Brief
A Phase 4 clinical trial evaluating Magnetic Resonance Imaging, Febuxostat, and 1 other intervention for Gout. Completed, enrolled 74 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
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.
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.