Study Phase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

Trial Information

Generic NameUstekinumabProduct NameSTELARA®Therapeutic AreaDigestive System DiseasesEnrollment769% Female57.2%% White84.1%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO1275CRD3001Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)36

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

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.