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An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications

Trial Profile

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 16 Jul 2023

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At a glance

  • Drugs Vedolizumab (Primary) ; Adalimumab; Methotrexate
  • Indications Crohn's disease
  • Focus Therapeutic Use
  • Sponsors Takeda
  • Most Recent Events

    • 11 Jul 2022 Status changed from active, no longer recruiting to completed.
    • 22 Sep 2021 An additional dose of Adalimumab (80 mg) has been added to the treatments section along with the previously existing doses of 160 and 40 mg.
    • 15 Jul 2020 Planned End Date changed from 13 Sep 2022 to 14 Jul 2022.
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