Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Adalimumab; Prednisone; Azathioprine
Intervention type(s): Biological; Drug; Drug
Intervention description(s): If adalimumab was initiated, it was administered subcutaneously as a 160 mg induction dose the first week, followed by 80 mg 2 weeks later, followed by 40 mg every other week as a maintenance dose. The dose of adalimumab was increased from 40 mg eow to 40 mg every week in participants with an inadequate response and de-escalated to 40 mg eow in participants who met success criteria.; The suggested regimen for participants initiating prednisone consisted of a maximum dose of prednisone 40 mg/day for 2 weeks, followed by a fixed taper for 6 weeks.; Participants with normal thiopurine methyltransferase (TPMT) enzyme activity could receive oral azathioprine 2.5 mg/kg/day. In participants with intermediate TPMT enzyme activity azathioprine was initiated at a dose of 1.25 mg/kg/day. The dose of azathioprine was adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine.
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Prednisone; Adalimumab; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment