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A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy

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Trial Profile

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Sep 2022

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At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
  • Indications Crohn's disease
  • Focus Therapeutic Use
  • Acronyms CERTIFI
  • Sponsors Centocor

    • Most Recent Events

    • 20 Sep 2022 Data from 4 studies were pooled (NCT00771667; NCT01369329; NCT01369342 & NCT01369355) for characterizes the population pharmacokinetic (PK) and exposure-response (E-R) relationships of ustekinumab in patients with CD published in the Clinical Therapeutics
    • 23 May 2021 Results of pooled analysis 6 phase 2/3 IBD studies ( (T07, CERTIFI, UNITI, IM-UNITI, UNIFI)evaluating integrated analysis of the long-term 2020 IBD presented at the Digestive Disease Week 2021
    • 23 May 2021 Results of pooled analysis from 1 UC and 4 CD studies: UNIFI, CERTIFI, UNITI-1, UNITI-2 and IM-UNITI assessing pregnancy outcomes in women exposed to Ustekinumab presented at the Digestive Disease Week 2021
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