Magnetic Resonance Imaging in Subjects With Gouty Tophi
A Study to Validate Magnetic Resonance Imaging (MRI) in the Quantitative Assessment of Gouty Tophi.
2 other identifiers
observational
32
0 countries
N/A
Brief Summary
The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging (MRI) in the quantitative assessment of tophus volume.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2002
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedResults Posted
Study results publicly available
July 16, 2009
CompletedJuly 27, 2010
July 1, 2010
10 months
September 12, 2005
March 12, 2009
July 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (1)
1
Volumes/measurements of tophi determined by serial MRIs
Interventions
Eligibility Criteria
Subjects with palpable gouty tophi.
You may qualify if:
- Subjects with gout and at least one tophi.
You may not qualify if:
- Unable to undergo MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Related Publications (1)
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.
PMID: 16620352RESULT
Related Links
Biospecimen
None taken or retained.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY CHAIR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
March 1, 2002
Primary Completion
January 1, 2003
Study Completion
January 1, 2003
Last Updated
July 27, 2010
Results First Posted
July 16, 2009
Record last verified: 2010-07