An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
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|ClinicalTrials.gov Identifier: NCT01112982|
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : July 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gout||Other: Magnetic Resonance Imaging Other: Plain Radiographs Drug: Febuxostat Drug: Colchicine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Shifting the Paradigm of Gout: An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Other: Magnetic Resonance Imaging
An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Other Name: 3 Tesla MRI
Other: Plain Radiographs
Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
Other Name: Xrays
Febuxostat Sub-Study Arm
To analyze the effect of urate-lowering therapy (specifically with febuxostat [Uloric]) on the synovial pannus in the "index joint" of a subgroup of patients. Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug other than febuxostat (Uloric) and who have a serum urate level of > or = to 9.0, will be treated with febuxostat (Uloric) and their serum urate level will be followed at months 1, 3, 6, and 9. MRI (with and without gadolinium) of the same "index joint" will be repeated at month 9 to assess for the presence and degree of synovial pannus. Because initiation of urate-lowering therapy can induce acute attacks of gout, these subjects will also be started on colchicine as a prophylactic (and remain on colchicine for 6 months).
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.
Other Name: Uloric
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.
Other Name: Colcrys
- Presence of synovial pannus in index joint. [ Time Frame: MRI and baseline uric acid level will be performed upon enrollment in the study. ]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.
- Effect of urate-lowering therapy (specifically with febuxostat [Uloric]) on synovial pannus. [ Time Frame: Upon enrollment into study, and at month 9. ]A sub-study in a subgroup of patients will analyze the effect of urate-lowering therapy (specifically with febuxostat [Uloric]) on synovial pannus in the "index joint" by comparing the baseline MRI with a repeat MRI of the same joint after 9 months of therapy with febuxostat.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112982
|United States, Florida|
|University of South Florida Medical Clinics|
|Tampa, Florida, United States, 33612-4742|
|Study Director:||Ernesto J Rodriguez, MD||University Of South Florida, Department of Rheumatology|
|Principal Investigator:||John D Carter, MD||University Of South Florida, Department of Rheumatology|