Study Phase 3

A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

Trial Information

Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment60% Female53.3%% White81.7%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T72Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)14.5

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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