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A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard
Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to
Severely Active Ulcerative Colitis
This Phase 3 study design includes a Screening Period, an 8-Week Double-Blind Induction Period and a
44-Week Double-Blind Maintenance Period.
Subjects will have moderately to severely active UC as defined by a Mayo Score of 6 to 12 points with
an endoscopy subscore of 2 or 3, confirmed by a central reader. Subjects who meet all of the inclusion
criteria and none of the exclusion criteria will be enrolled into the 8-week Induction Period. For all
Mayo Score evaluations throughout the study, the stool frequency and the rectal bleeding subscores will
be calculated based on entries recorded into the subject's diary based on 5 days prior to each study visit.
During the Induction Period, subjects will be randomized at Baseline to one of 2 double-blinded
adalimumab induction regimens (higher dose or standard dose) in a 3:2 ratio, as shown in the following
figure. Use of the 3:2 randomization scheme allows for collection of additional safety data with the
higher induction dose regimen. The randomization will be stratified by previous infliximab use and
Baseline corticosteroid use.