Study Phase 3

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Trial Information

Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaDigestive System DiseasesEnrollment291% Female40.2%% White82.1%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T16Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)40

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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