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

• Sponsor: University of South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01112982
• Collaborator: Takeda Pharmaceuticals North America, Inc. (Industry)
• Enrollment: 74
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gout	Other: Magnetic Resonance Imaging; Drug: Febuxostat; Drug: Colchicine	Phase 4

Detailed Description

The clinical history of untreated gout transitions from an acute intermittent arthritis to a chronic inflammatory arthritis. This tells us that at some point the inflammation associated with gout does not abate. Our group recently completed an advanced imaging study in patients with early gout that suggested nearly 60% of subjects had synovial pannus during intercritical gout. This is likely more prevalent in patients with more advanced gout. The presence of synovial pannus also likely correlates with serum urate levels. 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, determine the degree of this inflammation, and correlate it with their serum urate levels. Secondary endpoints will include assessments for the presence of other characteristic findings of gout on these MRI (i.e. erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, and soft tissue edema). We will also be checking serum high-sensitivity CRP levels to evaluate for any correlation with synovial pannus, and assess baseline radiographs of the "index" joint for the presence of erosive changes, which will be correlated with the presence and severity of synovial pannus in that same joint. Analysis will also be performed to see if there is a correlation with serum urate levels. A sub-study will be performed assessing the effect of aggressive serum urate lowering therapy (specifically with febuxostat [Uloric]) on this chronic inflammation; i.e. synovial pannus.

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 1, 2010
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Febuxostat Sub-Study 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. Magnetic Resonance Imaging (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).	Other: Magnetic Resonance Imaging; An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).; Other Names: 3 Tesla Magnetic Resonance Imaging ; Drug: Febuxostat; 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 Names: Uloric ; Drug: Colchicine; 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 Names: Colcrys
Other: MRI of index joint To analyze synovial pannus in the Magnetic Resonance Imaging (with and without gadolinium) of the "index joint" on Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug other than febuxostat (Uloric).	Other: Magnetic Resonance Imaging; An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).; Other Names: 3 Tesla Magnetic Resonance Imaging

Outcome Measures

Primary Outcome Measures

1. Number and Percentage of Participants With Evidence of Chronic Ongoing Synovial-Based Inflammatory Disease at Baseline. [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.

Secondary Outcome Measures

1. Number and Percentage of Substudy Participants for Whom the Severity of Synovial Pannus Was Significantly Reduced After 9 Months of Treatment With Febuxostat (Uloric). [Upon enrollment into study, and at month 9.]

   A sub-study in a subgroup of patients will analyze the Number and Percentage of Substudy Participants for whom the Severity of Synovial Pannus was Significantly Reduced After 9 Months of Treatment with Febuxostat (Uloric) in the "index joint" by comparing the baseline MRI with a repeat MRI of the same joint.

2. Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels. [Upon enrollment into study]

   Number of Participants with Other Characteristic Findings of Gout on these MRI's. These include erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, and soft tissue edema. These secondary endpoints will also be summed with patients' serum urate levels.

3. Mean Serum Urate Levels for Previous 2 Years at Baseline. [previous 2 years upon enrollment into study]

   Determine if there is a correlation between the prevalence and severity of synovial pannus in the "index joint" with the patients' mean serum urate level from the previous 2 years at baseline.

4. The Severity of Synovial Pannus the Day of Serum High-sensitivity C-Reactive Protein and Magnetic Resonance Imaging [Upon enrollment into study at screening.]

   Determine if the Number of Participants Prevalence and Severity of Synovial Pannus in the "Index Joint" with the patient's serum high-sensitivity C-Reactive Protein on the same day as the Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be assessed for the severity of synovial pannus, which is graded on a scale of 1 to 6 (with 6 being the most severe).

5. 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. [Upon enrollment into study]

   Baseline radiographs of the "index" joint will also be obtained on the same day as their MRI and assessed for the presence or absence of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, or soft tissue edema. This will be correlated with the presence and severity of synovial pannus in that same joint. The analysis will also be performed to see if there is a correlation with serum urate levels and the presence of erosions on their plain radiograph.

6. High-sensitivity C-Reactive Protein Concentrations [Upon enrollment into study at screening.]

   The concentration of serum high-sensitivity C-Reactive Protein at enrollment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Florida Medical Clinics	Tampa	Florida	United States	33612-4742

Sponsors and Collaborators

• University of South Florida
• Takeda Pharmaceuticals North America, Inc.

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Medline Plus: Gout
• Medline Plus: Febuxostat
• Medline Plus: Colchicine
• Medline Plus: MRI

Publications

None provided.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT01112982
• Other Study ID Numbers: Pro00000136
• First Posted: Apr 29, 2010
• Last Update Posted: Aug 7, 2019
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of South Florida: Gout; Synovial pannus; Magnetic resonance imaging
• Additional relevant MeSH terms: Inflammation; Colchicine; Febuxostat

Study Results

Participant Flow

Arm/Group Title	MRI of Index Joint
Arm/Group Description	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. Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images). Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
Period Title: Overall Study
STARTED	74
COMPLETED	72
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	MRI of Index Joint
Arm/Group Description	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. Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images). Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
Overall Participants	72
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	67 93.1%
>=65 years	5 6.9%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	56.4
Sex: Female, Male (Count of Participants)
Female	7 9.7%
Male	65 90.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 12.5%
Not Hispanic or Latino	60 83.3%
Unknown or Not Reported	3 4.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	10 13.9%
White	59 81.9%
More than one race	0 0%
Unknown or Not Reported	3 4.2%
Region of Enrollment (Count of Participants)
United States	72 100%

Outcome Measures

1. Primary Outcome

Title	Number and Percentage of Participants With Evidence of Chronic Ongoing Synovial-Based Inflammatory Disease at Baseline.
Description	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.
Time Frame	MRI and baseline uric acid level will be performed upon enrollment in the study.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI of Index Joint
Arm/Group Description	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. Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images). Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
Measure Participants	72
Count of Participants [Participants]	63 87.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments	Presence of synovial pannus and the serum urate level.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Number and Percentage of Substudy Participants for Whom the Severity of Synovial Pannus Was Significantly Reduced After 9 Months of Treatment With Febuxostat (Uloric).
Description	A sub-study in a subgroup of patients will analyze the Number and Percentage of Substudy Participants for whom the Severity of Synovial Pannus was Significantly Reduced After 9 Months of Treatment with Febuxostat (Uloric) in the "index joint" by comparing the baseline MRI with a repeat MRI of the same joint.
Time Frame	Upon enrollment into study, and at month 9.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Febuxostat Sub-Study
Arm/Group Description	The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
Measure Participants	32
Count of Participants [Participants]	25 34.7%

3. Secondary Outcome

Title	Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.
Description	Number of Participants with Other Characteristic Findings of Gout on these MRI's. These include erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, and soft tissue edema. These secondary endpoints will also be summed with patients' serum urate levels.
Time Frame	Upon enrollment into study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI of Index Joint
Arm/Group Description	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. Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images). Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
Measure Participants	72
Erosive Changes	31 43.1%
Intraosseous tophi	25 34.7%
Soft tissue tophi	11 15.3%
Joint effusion	14 19.4%
Bone marrow edema	40 55.6%
Soft tissue edema	28 38.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments	The Severity of Synovial Pannus and the Serum Urate level.
	Type of Statistical Test	Other
	Comments	Spearman Correlation Coefficient
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	t-test, 1 sided
	Comments

4. Secondary Outcome

Title	Mean Serum Urate Levels for Previous 2 Years at Baseline.
Description	Determine if there is a correlation between the prevalence and severity of synovial pannus in the "index joint" with the patients' mean serum urate level from the previous 2 years at baseline.
Time Frame	previous 2 years upon enrollment into study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI of Index Joint
Arm/Group Description	To analyze synovial pannus in the Magnetic Resonance Imaging (with and without gadolinium) of the "index joint" on Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug. Magnetic Resonance Imaging: An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Measure Participants	72
Mean (Standard Deviation) [mg/dL]	7.93 (2.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments	correlation between severity of synovial pannus and the serum urate level.
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	t-test, 1 sided
	Comments

5. Secondary Outcome

Title	The Severity of Synovial Pannus the Day of Serum High-sensitivity C-Reactive Protein and Magnetic Resonance Imaging
Description	Determine if the Number of Participants Prevalence and Severity of Synovial Pannus in the "Index Joint" with the patient's serum high-sensitivity C-Reactive Protein on the same day as the Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be assessed for the severity of synovial pannus, which is graded on a scale of 1 to 6 (with 6 being the most severe).
Time Frame	Upon enrollment into study at screening.

Outcome Measure Data

Analysis Population Description

Severity of Synovial Pannus in the "Index Joint"

Arm/Group Title	MRI of Index Joint	Febuxostat Sub-Study
Arm/Group Description	To analyze synovial pannus in the Magnetic Resonance Imaging (with and without gadolinium) of the "index joint" on Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug. Magnetic Resonance Imaging: An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).	The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
Measure Participants	72	25
Mean (Standard Deviation) [units on a scale]	2.99 (1.3)	3.42 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments	The presence of synovial pannus in the "index joint".
	Method	t-test, 1 sided
	Comments

6. Secondary Outcome

Title	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.
Description	Baseline radiographs of the "index" joint will also be obtained on the same day as their MRI and assessed for the presence or absence of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, or soft tissue edema. This will be correlated with the presence and severity of synovial pannus in that same joint. The analysis will also be performed to see if there is a correlation with serum urate levels and the presence of erosions on their plain radiograph.
Time Frame	Upon enrollment into study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI of Index Joint
Arm/Group Description	To analyze synovial pannus in the Magnetic Resonance Imaging (with and without gadolinium) of the "index joint" on Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug. Magnetic Resonance Imaging: An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Measure Participants	72
Presence	31 43.1%
Absence	41 56.9%
Presence	24 33.3%
Absence	48 66.7%
Presence	25 34.7%
Absence	47 65.3%
Presence	11 15.3%
Absence	61 84.7%
Presence	14 19.4%
Absence	58 80.6%
Presence	40 55.6%
Absence	32 44.4%
Presence	28 38.9%
Absence	44 61.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments	The absence of erosive changes.
	Type of Statistical Test	Other
	Comments	Kappa Coefficient
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments	the absence of Intraosseous Tophi.
Statistical Test of Hypothesis	p-Value	0.33
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments	The absence of Soft Tissue Tophi
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments	The absence of Joint Effusion.
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments	The absence of Bone Marrow Edema.
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments	The absence of Soft Tissue Edema.
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	High-sensitivity C-Reactive Protein Concentrations
Description	The concentration of serum high-sensitivity C-Reactive Protein at enrollment.
Time Frame	Upon enrollment into study at screening.

Outcome Measure Data

Analysis Population Description

Serum High-Sensitivity C-Reactive Protein

Arm/Group Title	MRI of Index Joint	Febuxostat Sub-Study
Arm/Group Description	To analyze synovial pannus in the Magnetic Resonance Imaging (with and without gadolinium) of the "index joint" on Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug. Magnetic Resonance Imaging: An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).	The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
Measure Participants	72	25
Mean (Standard Deviation) [mg/dL]	0.52 (0.84)	0.37 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments	The Presence of synovial Pannus in the "index joint".
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MRI of Index Joint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments	The Severity of Synovial Pannus in the "index joint".
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	At screening, baseline, week 2, month 1, month 3, month 6, and month 9 adverse events were collected on 72 study participants.
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were monitored/assessed.
Arm/Group Title	MRI of Index Joint
Arm/Group Description	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. Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images). Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
All Cause Mortality
	MRI of Index Joint
	Affected / at Risk (%)	# Events
Total	0/72 (0%)
Serious Adverse Events
	MRI of Index Joint
	Affected / at Risk (%)	# Events
Total	1/72 (1.4%)
Cardiac disorders
exacerbation of congestive heart failure	1/72 (1.4%)	1
Other (Not Including Serious) Adverse Events
	MRI of Index Joint
	Affected / at Risk (%)	# Events
Total	8/72 (11.1%)
Cardiac disorders
thrombocytopenia	1/72 (1.4%)	1
Gastrointestinal disorders
mild nausea	2/72 (2.8%)	2
Hepatobiliary disorders
increased liver function tests	8/72 (11.1%)	8

Limitations/Caveats

two subjects who did not complete the entire protocol, one exceeded the weight limit to complete the MRI, and the other withdrew consent.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.