Clinical Trial: Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerat

Brief Summary: To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis.

Detailed Summary:
Sponsor: AbbVie (prior sponsor, Abbott)

Current Primary Outcome:

  • Change from Baseline in Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192, Week 240; Week 292 Week 340, Week 388, ]
  • Change from Baseline in Partial Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292 Week 340 and Week 388 ]


Original Primary Outcome:

  • Change from Baseline in Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ]
  • Change from Baseline in Partial Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ]


Current Secondary Outcome:

  • Change from Baseline in IBDQ & SF-36 [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292 Week 340 and Week 388 ]
  • Change from Baseline in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292; Week 340; Week 388, ]
  • AEs, Laboratory data, physical exams, and vital signs [ Time Frame: Throughout course of the study ]
  • Cumulative number of unscheduled outpatient visits [ Time Frame: Throughout course of the study ]


Original Secondary Outcome:

  • Change from Baseline in IBDQ & SF-36 [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ]
  • Change from Baseline in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ]
  • Cumulative number of unscheduled outpatient visits [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ]
  • AEs, Laboratory data, physical exams, and vital signs [ Time Frame: Throughout course of the study ]


Information By: AbbVie

Dates:
Date Received: December 12, 2007
Date Started: November 2007
Date Completion:
Last Updated: April 26, 2017
Last Verified: April 2017