Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab (Study P04440) (EUSpA)
Subjects will be given 3 infusions of infliximab according to the label at week 0, 2, and 6. Subjects will be followed for a maximum of 18 weeks or until relapse. This study will assess the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis response and relapse in subjects treated with infliximab.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Study of Peripheral Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab|
- The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Two measures were to be used for each enthesis evaluation. 1.) Vascularization: yes/no. 2.) Area of hyper-vascularization: mm^2 (continuous) using proprietary software. This study was terminated early due to slow recruitment. As a result, efficacy analyses were not performed.
|Study Start Date:||January 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Infliximab 5 mg/kg
Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
PDUS scored for each enthesitis every 2 weeks for 24 weeks.Drug: Infliximab
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