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Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated with Ustekinumab

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Trial Profile

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated with Ustekinumab

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms STARDUST; STARDUST LTE
  • Sponsors Janssen-Cilag

    • Most Recent Events

    • 30 Nov 2023 Results (n=323) from long-term extension period assessing clinical and endoscopic outcomes with ustekinumab in patients with Crohn's disease through week 104 published in the Alimentary Pharmacology and Therapeutics
    • 11 Oct 2022 Results (n=323) assessing the long-term extension period for health-related quality of life measures and the effect of ustekinumab on work productivity and activity impairment at week 104, comparing treat-to-target and standard of care, presented at the 30th United European Gastroenterology Week.
    • 11 Oct 2022 Results of incorporated-intestinal ultrasound sub-study (n=77) assessing incorporated-intestinal ultrasound endpoints and their relation-ship with ustekinumab exposure presented at the 30th United European Gastroenterology Week.

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