Study Phase 3

A Placebo-controlled, Repeated-dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients with Enterocutaneous Fistulae as a Complication of Crohn's Disease

Trial Information

Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupTumor Necrosis Factor Alpha (TNF-α) InhibitorsCondition StudiedCrohn's Disease
Sponsor Protocol NumberC0168T20Enrollment94Data PartnerJohnson & Johnson% Female53%Mean/Median Age (Years)37.2% White91%

Supporting Documentation

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

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