Study Phase 3

ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease

Trial Information

Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment580% Female61.2%% White94%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T21Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)35

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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