Phase 4
Completed N=74
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
Source: ClinicalTrials.gov NCT01112982 ↗Enrolled (actual)
74
Serious AEs
1.4%
Results posted
Aug 2019
Primary outcomePrimary: Number and Percentage of Participants With Evidence of Chronic Ongoing Synovial-Based Inflammatory Disease at Baseline. — 63 Participants — p=0.34
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With Evidence of Chronic Ongoing Synovial-Based Inflammatory Disease at Baseline. |
63 | 0.34 |
| SECONDARY Number and Percentage of Substudy Participants for Whom the Severity of Synovial Pannus Was Significantly Reduced After 9 Months of Treatment With Febuxostat (Uloric). |
25 | — |
| SECONDARY Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels. |
31; 25; 11; 14; 40; 28 | 0.73 |
| SECONDARY Mean Serum Urate Levels for Previous 2 Years at Baseline. |
7.93 | 0.73 |
| SECONDARY The Severity of Synovial Pannus the Day of Serum High-sensitivity C-Reactive Protein and Magnetic Resonance Imaging |
2.99; 3.42 | 0.32 |
| SECONDARY Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph. |
31; 41; 24; 48; 25; 47 | 0.09 |
| SECONDARY High-sensitivity C-Reactive Protein Concentrations |
0.52; 0.37 | 0.32 |
Eligibility Criteria
Inclusion Criteria
- Age > or = 18 - Open ended to both males and females.
- 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).
- English of Spanish speaking
- Able to give informed consent
Exclusion Criteria
- Age 1.8 mg/dL
- Patients taking oral corticosteroids (any dose) [or within 4 weeks]
- Parenteral or intraarticular corticosteroids within 6 weeks
- Allergy to gadolinium contrast dye
- Any contraindication to receiving a MRI
- Pregnant women
- Allergy to febuxostat (Uloric) or colchicine [substudy subjects only]
Data sourced from ClinicalTrials.gov (NCT01112982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.