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 AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupInterleukin InhibitorsCondition StudiedCrohn's Disease
Sponsor Protocol NumberCNTO1275CRD3007Enrollment386Data PartnerJohnson & Johnson% Female52.1%Mean/Median Age (Years)37.2% White89.4%

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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