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A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 15 Jun 2023

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At a glance

  • Drugs Golimumab (Primary)
  • Indications Ulcerative colitis
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms PURSUIT-Induction; PURSUIT-SC
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 01 Jun 2023 Results of post-hoc pooled analysis of two studies ( PURSUIT-SC & PURSUIT - Maintenance) assessing effect of race on response to golimumab, published in the Inflammatory Bowel Diseases.
    • 22 Jan 2020 Results assessing the population pharmacokinetic (PK) properties of golimumab and exposure-response for efficacy and safety, using data from combined Phase II/III UC studies (NCT00488774, NCT00487539, and NCT00488631) published in the Clinical Therapeutics
    • 12 Jun 2018 Results of individual participant data (IPD) pooled analysis of five trials of infliximab and golimumab in UC, to evaluate whether concomitant use of 5-Aminosalicylates modifies clinical outcomes, were published in the American Journal of Gastroenterology.

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