Study Phase 3

Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE® (infliximab) and REMICADE plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease)

Trial Information

Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment508% Female48.4%% White92.8%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T67Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)34

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

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