Study Phase 3

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

Trial Information

Generic NameUstekinumabProduct NameSTELARA®Therapeutic AreaImmune System DiseasesEnrollment386% Female52.1%% White89.4%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO1275CRD3007Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)37.2

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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