drugset / Trial / NCT01112982
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
Phase 4
Completed
74 enrolled
University of South Florida
Takeda Pharmaceuticals North America, Inc. · collab
Non-randomizedSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2010-05
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Febuxostat | Small molecule | 40 mg | — |
| Subject | Febuxostat | Small molecule | 80 mg | — |
| Background | Colchicine | Small molecule | 0.6 mg | Oral |