Crohn's Disease Clinical Trial
Official title:
An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease
The primary objective of this study was to demonstrate that tight control of disease activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers (high sensitivity C-reactive protein [hs-CRP] and fecal calprotectin), and corticosteroid use, improves the rate of mucosal healing 48 weeks after randomization compared with management using less stringent criteria based only on CDAI and corticosteroid use.
The study included a 1- to 3-week screening period, up to 8 weeks of prednisone run-in
treatment, a 48-week post-randomization treatment period, and a 70 day follow-up phone call
or clinic visit, for a total duration of up to 69 weeks.
Participants who met entry criteria were enrolled and initiated an oral prednisone regimen at
Baseline (Week 0). At the first key visit, participants were randomized into 1 of 2 groups
(Tight Control group or Clinically Driven group), with stratification according to screening
smoking status, weight, and disease duration.
The first key visit was the randomization visit; subsequent key visits occurred every 12
weeks following the first key visit. Randomization normally took place 9 weeks after
Baseline. However, participants who fulfilled the early randomization criteria may have been
randomized as early as the Baseline (Week 0) visit. Therapeutic option changes, if
appropriate, occurred at key visits based on results from previous success criteria visits.
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