Study Phase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Trial Information

Generic NameUstekinumabProduct NameSTELARA®Therapeutic AreaDigestive System DiseasesEnrollment961% FemaleN/A% WhiteN/A
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO1275UCO3001Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)41.7

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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