The primary outcome measure of the study is to demonstrate the safety and tolerability of GSK1070806 in the Behcet's disease population at 24 weeks, with biochemical and clinical efficacy and mechanistic studies to further explore the pathogenesis of Behcet's disease important secondary and exploratory outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single 10mg/kg infusion on Day 0
Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, United Kingdom
The occurrence of all moderate, severe and life threatening adverse events
Events that that are possibly, probably or definitely attributable to a single IV dose of GSK1070806 (10mg/kg)
Time frame: 24 weeks
All adverse events, including mild events
Events that that are possibly, probably or definitely attributable to a single IV dose of GSK1070806 (10mg/kg)
Time frame: 24 weeks
Measurement of disease activity
Using a clinical scoring tool, the Behcet's disease current activity form (BDCAF)
Time frame: 24 weeks
Measurement of the accumulation of damage
Using a clinical scoring tool, the Vasculitis Damage Index (VDI)
Time frame: 24 weeks
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