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A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290

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Trial Profile

A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2025

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors AbbVie

Most Recent Events

  • 01 May 2025 Safety end point "Number of Participants with Adverse Events (AEs)" has been added to primary endpoints.
  • 01 May 2025 Status changed from active, no longer recruiting to completed.
  • 18 Feb 2025 Planned End Date changed from 14 May 2025 to 1 Apr 2025.

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