Janssen Crohn’s (Stelara vs. Humira)

Blinded, active-controlled study to compare the efficacy and safety of Ustekinumab to that of Adalimumab in the treatment of biologic naive subjects with moderately to severely active Crohn’s Disease

  • Males and females >18 years of age with a diagnosis for at least 3 months of moderately to severely active Crohn’s Disease
  • Has failed conventional therapy: is currently receiving corticosteroids and/or immunomodulators at adequate therapeutic doses OR has a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators OR is corticosteroid dependent or has a history of corticosteroid dependency. AND has a biologic naive
  • Each patient will get an infusion of Stelara or placebo and four (4) injections of Humira or placebo at baseline