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Outcome: 4c875f270012fc9194fc048945b6afac [RDF]

Label 4c875f270012fc9194fc048945b6afac
Slug 4c875f270012fc9194fc048945b6afac
Safety issue
Measure Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure
Description ASAS 40 responder: improvement of >= 40% and absolute improvement of >= 20 units (on a scale of 0 to 100) in >= 3 of the 4 domains: Patient global assessment (VAS score [0-100 scale]); Pain (Total Back Pain VAS score 0-100 scale); Function (BASFI score 0-100 scale); Inflammation (the mean of the two morning stiffness-related BASDAI VAS scores (i.e. the average of items 5 and 6 of the BASDAI. Applied to each scale. In addition, absence of deterioration in the potential remaining domain, where deterioration is defined as a net worsening of > 0 units (on a scale of 0 to 100).
Time frame Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244 and 260
Provenances http://clinicaltrials.gov/show/NCT00195819?displayxml=true
Similars None
Interlinks None