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Multicenter Open-label Study to Evaluate the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine for the Treatment of Children and Adolescents Newly Diagnosed With Ulcerative Colitis.

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Trial Profile

Multicenter Open-label Study to Evaluate the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine for the Treatment of Children and Adolescents Newly Diagnosed With Ulcerative Colitis.

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Mesalazine (Primary) ; Anti-TNF alpha domain antibody; Azathioprine; Ciclosporin; Immunomodulators; Prednisone; Prednisone; Tacrolimus
  • Indications Ulcerative colitis
  • Focus Biomarker; Therapeutic Use
  • Acronyms PROTECT

    • Most Recent Events

    • 23 May 2021 Results assessing the prognostic ability of our gene expression array for predicting outcomes in a large inception cohort study, PROTECT, of children with ulcerative-colitis treated with standardized therapy based on initial clinical severity, presented at the Digestive Disease Week 2021.
    • 02 Aug 2019 Primary endpoint (Corticosteroid free remission (SFR)) has been met according to Results published in the Alimentary Pharmacology and Therapeutics.
    • 02 Aug 2019 Results published in the Alimentary Pharmacology and Therapeutics.
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