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: 31 Jan 2018

At a glance

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

    • 31 Jan 2018 Results reporting on ustekinumab pharmacokinetics (PK) and exposure-response (ER) relationships using data derived from previously reported Phase 3 induction and maintenance studies in Crohns Disease (NCT01369329 (UNITI 1), NCT01369342 (UNITI 2), and NCT01369355 (IM UNITI)) published in the Gastroenterology
    • 01 Nov 2017 Results (n=458) assessing response and remission rates from UNITI-1 and UNITI-2 trials, presented at the 25th United European Gastroenterology Week.
    • 30 Oct 2017 Results published in the Janssen Cilag Media Release
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top