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A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Trial Profile

A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2019

At a glance

  • Drugs Golimumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms PURSUIT-J
  • Sponsors Janssen Pharmaceutical KK
  • Most Recent Events

    • 17 Jun 2019 Retrospective analysis results are presented in a a Janssen media release.
    • 17 Jun 2019 According to a Janssen media release, retrospective analysis data (n=92) from this study were presented at the 7th Asian Crohn's Disease / Colitis (AOCC) Conference.
    • 09 Jul 2018 According to a Janssen media release, based on the data from post-hoc analyses of this trial SIMPONI receives European comission approval for early dose optimization treatment in patients with ulcerative colitis.
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