Validation Study of Physical Measurement of Tophi

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00175006
• Collaborator: (none)
• Enrollment: 13
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.

Condition or Disease	Intervention/Treatment	Phase
Gout	Other: Measurement of Tophi to validate procedure

Detailed Description

Gout is a chronic urate crystal deposition disorder. Left untreated, gout may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration greater than 7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis.1 As serum urate levels increase beyond greater than 7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine oxidase/dehydrogenase inhibitor. Febuxostat is being developed as an orally administered agent for the management of hyperuricemia in patients with gout.

Subjects with palpable tophi >10 millimeters (mm) in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement.

Study Design

• Study Type: Observational
• Actual Enrollment: 13 participants
• Time Perspective: Prospective
• Official Title: A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules in Subjects With Gout.
• Study Start Date: Nov 1, 2002
• Actual Primary Completion Date: Jan 1, 2003
• Actual Study Completion Date: Jan 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Tophi Participants	Other: Measurement of Tophi to validate procedure; Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.

Outcome Measures

Primary Outcome Measures

1. Average Percent Difference in Area Between Visits [Visit 1 (Day 1) and Visit 2 (Days 6-11)]

   The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.

2. Average Percent Difference in Area Between Raters [Visit 1 (Day 1 ) and Visit 2 (Day 6-11)]

   Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must have at least 1 palpable gouty tophus nodule in the foot/ankle, hand/wrist, or elbow, confirmed as gouty by prior diagnosis according to ACR criteria.

• The tophus must be solid, round, non-tender, intact, and larger than 10mm in both length and width.

• Joints nearest and immediately adjacent to the selected tophus must not be acutely inflamed.

• Must be on stable treatment for gout with no medication changes in the past 30 days.

Exclusion Criteria:

• Must be able to return to the clinical site within 10 days.

• Must not have allergy to ink.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Medical Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Uloric Package Insert

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00175006
• Other Study ID Numbers: C02-019; U1111-1114-1944
• First Posted: Sep 15, 2005
• Last Update Posted: Jul 27, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Hyperuricemia; Tophi; Tophus; Drug Therapy
• Additional relevant MeSH terms: Gout

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled at 2 study sites in the United States from 19 November 2002 to 09 January 2003.

Arm/Group Title	Tophi Participants
Arm/Group Description	Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
Period Title: Overall Study
STARTED	13
COMPLETED	13
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Tophi Participants
Arm/Group Description	Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
Overall Participants	13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.5 (14.1)
Age, Customized (participants) [Number]
18 years to 35 years	0 0%
36 years to 50 years	2 15.4%
51 years to 65 years	6 46.2%
66 years to 85 years	5 38.5%
Sex: Female, Male (Count of Participants)
Female	2 15.4%
Male	11 84.6%
Race/Ethnicity, Customized (participants) [Number]
White	5 38.5%
Black or African American	7 53.8%
Asian	1 7.7%

Outcome Measures

1. Primary Outcome

Title	Average Percent Difference in Area Between Visits
Description	The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.
Time Frame	Visit 1 (Day 1) and Visit 2 (Days 6-11)

Outcome Measure Data

Analysis Population Description

Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled. Change in tophus size over 10 days was not expected.

Arm/Group Title	Tophi Participants
Arm/Group Description	Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
Measure Participants	13
Average Percent Difference	29 (33)

2. Primary Outcome

Title	Average Percent Difference in Area Between Raters
Description	Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.
Time Frame	Visit 1 (Day 1 ) and Visit 2 (Day 6-11)

Outcome Measure Data

Analysis Population Description

Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled.

Arm/Group Title	Tophi Participants
Arm/Group Description	Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
Measure Participants	13
Average Percent Difference	32 (27)

Adverse Events

Arm/Group Title	Tophi Participants
Arm/Group Description	Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
All Cause Mortality
	Tophi Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Tophi Participants
	Affected / at Risk (%)	# Events
Total	0/13 (0%)
Other (Not Including Serious) Adverse Events
	Tophi Participants
	Affected / at Risk (%)	# Events
Total	0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.