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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-9856 | Registry Identifier | WHO |
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The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging (MRI) in the quantitative assessment of tophus volume.
This is a multi-center, validation study of MRI in the quantitative assessment of gouty tophi. Subjects with palpable gouty tophi (confirmed by aspiration of the tophus) in select anatomical sites (foot, hand or elbow) will undergo pre- and post contrast MRI on two occasions separated by 5 to 10 days. This study will consist of up to 4 study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Volumes/measurements of tophi determined by serial MRIs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Procedure | Subjects underwent MRI to evaluate tophi. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Tophi by MRI - Difference in Volument Between Visits | Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers. | Visit 1 (Day 1) and Visit 2 (Days 6-11) |
| Measurement of Tophi by MRI - Difference in Volume Between Readers | Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits. | Visit 1 (Day 1) and Visit 2 (Days 6-11) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with palpable gouty tophi.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16620352 | Result | Schumacher HR Jr, Becker MA, Edwards NL, Palmer WE, MacDonald PA, Palo W, Joseph-Ridge N. Magnetic resonance imaging in the quantitative assessment of gouty tophi. Int J Clin Pract. 2006 Apr;60(4):408-14. doi: 10.1111/j.1368-5031.2006.00853.x. |
| Label | URL |
|---|---|
| Uloric Package Insert | View source |
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Subjects with palpable gouty tophi in select anatomical sites underwent pre- and post-contrast Magnetic Resonance Imaging (MRI)
Subjects were enrolled at 6 study centers from 07 March 2002 to 28 January 2003.
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| ID | Title | Description |
|---|---|---|
| FG000 | Palpable Gouty Tophi Subjects | Volumes/measurements of tophi determined by serial MRI |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Palpable Gouty Tophi Subjects | Volumes/measurements of tophi determined by serial MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Tophi by MRI - Difference in Volument Between Visits | Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers. | Analysis was performed on the subjects with MRI tophus volume measurements at both visits from the same reader. Change in tophus size over 10 days was not expected. | Posted | Mean | Standard Deviation | centimeters³ (cm³) | Visit 1 (Day 1) and Visit 2 (Days 6-11) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palpable Gouty Tophi Subjects | Volumes/measurements of tophi determined by serial MRI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rate and Rhythm Disorders not elsewhere classified (NEC) | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Atonic and Hypomotility Disorders NEC | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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None taken or retained.
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Measurement of Tophi by MRI - Difference in Volume Between Readers | Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits. | Analysis was performed on the subjects with MRI tophus volume measurements from both readers at the same visit. | Posted | Mean | Standard Deviation | cm³ | Visit 1 (Day 1) and Visit 2 (Days 6-11) |
|
|
|
|
| 2 |
| 32 |
| 6 |
| 32 |
| Renal Failure and Impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nausea and Vomiting Symptoms | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Febrile Disorders | General disorders | MedDRA | Systematic Assessment |
|
| Muscle Related Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Nasal Congestion and Inflammations | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
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.
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |