Study Phase 3

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

Trial Information

Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaDigestive System DiseasesEnrollment1228% Female43%% White82.4%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T18Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)40.3

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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