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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: Colchicine; Febuxostat; Uric Acid

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]