Clinical Trial: Special Investigation on Long-term Treatment in Patients With Crohn's Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Special Investigation (Long-term Investigation) in Patients With Crohn's Disease

Brief Summary: This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.

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

Current Primary Outcome:

  • Number of patients with adverse events [ Time Frame: at month 6 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
  • Number of patients with adverse events [ Time Frame: at year 1 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
  • Number of patients with adverse events [ Time Frame: at year 1.5 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
  • Number of patients with adverse events [ Time Frame: at year 2 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
  • Number of patients with adverse events [ Time Frame: at year 2.5 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
  • Number of patients with adverse events [ Time Frame: at year 3 ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Crohn's Disease Activity Index [ Time Frame: at week 4 ]
    • Crohn's Disease Activity Index [ Time Frame: at month 3 ]
    • Crohn's Disease Activity Index [ Time Frame: at month 6 ]
    • Crohn's Disease Activity Index [ Time Frame: at year 1 ]
    • Crohn's Disease Activity Index [ Time Frame: at year 1.5 ]
    • Crohn's Disease Activity Index [ Time Frame: at year 2 ]
    • Crohn's Disease Activity Index [ Time Frame: at year 2.5 ]
    • Crohn's Disease Activity Index [ Time Frame: at year 3 ]
    • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at week 4 ]
    • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 3 ]
    • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 6 ]
    • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1 ]
    • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1.5 ]
    • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2 ]
    • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2.5 ]
    • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 3 ]


    Original Secondary Outcome: Same as current

    Information By: AbbVie

    Dates:
    Date Received: November 1, 2011
    Date Started: December 16, 2011
    Date Completion: October 31, 2018
    Last Updated: April 19, 2017
    Last Verified: April 2017