Study Phase 3

A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease

Trial Information

Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment112% Female41.1%% White83.9%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T47Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)13.3

Supporting Documentation

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

CSR Summary for open-label extension available here

Approved Data Requests Associated with this Trial

Disclaimer

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