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A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipilimumab) and/or Opdivo (Nivolumab)

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Trial Profile

A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipilimumab) and/or Opdivo (Nivolumab)

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 31 Aug 2017

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At a glance

  • Drugs Infliximab (Primary) ; Methylprednisolone (Primary) ; Prednisone (Primary)
  • Indications Diarrhoea
  • Focus Therapeutic Use
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 25 Aug 2017 Planned End Date changed from 17 Sep 2019 to 31 Mar 2017.
    • 25 Aug 2017 Planned primary completion date changed from 16 Dec 2018 to 21 Mar 2017.
    • 25 Aug 2017 Planned initiation date changed from 1 Dec 2016 to 16 Aug 2016.

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