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 Profile

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms UNITI-1
  • Sponsors Janssen-Cilag
  • Most Recent Events

    • 17 Jun 2017 Integrated safety results from 3 psoriatic arthritis , 5 Crohns disease, & 4 psoriasis trials presented at the 18th Annual Congress of the European League Against Rheumatism
    • 10 Jun 2017 Biomarkers information updated
    • 30 Mar 2017 According to a Janssen Pharmaceuticals media release, The Comany has recieved the approval of manufacturing and marketing application for ustekinumab 130mg IV injection for the induction treatment of Crohn's disease. The approval was based on the results of the phase III UNITI-1 and UNITI-2 trials.
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