Study Phase 3

ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease

Trial Information

Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment306% Female49%% White95.4%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T26Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)37

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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