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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01464333
Recruitment Status : Active, not recruiting
First Posted : November 3, 2011
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

November 1, 2011
November 3, 2011
February 1, 2018
December 16, 2011
March 31, 2018   (Final data collection date for primary outcome measure)
  • 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 2.5 ]
    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 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 3 ]
    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 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 ]
    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
Complete list of historical versions of study NCT01464333 on ClinicalTrials.gov Archive Site
  • Crohn's Disease Activity Index [ Time Frame: at year 1 ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1.5 ]
  • Crohn's Disease Activity Index [ Time Frame: at month 6 ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 6 ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 3 ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2.5 ]
  • Crohn's Disease Activity Index [ Time Frame: at week 4 ]
  • Crohn's Disease Activity Index [ Time Frame: at year 1.5 ]
  • 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 year 3 ]
  • Crohn's Disease Activity Index [ Time Frame: at month 3 ]
  • Crohn's Disease Activity Index [ Time Frame: at year 2.5 ]
  • Crohn's Disease Activity Index [ Time Frame: at year 2 ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1 ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2 ]
  • 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 ]
Not Provided
Not Provided
 
Special Investigation on Long-term Treatment in Patients With Crohn's Disease
Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Those who are receiving Humira in accordance with its indications for treatment and dosage regimens.
Crohn's Disease
Not Provided
Humira
those with an exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
525
March 31, 2018
March 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Crohn's disease indicated for Humira treatment with the recommended dosage regimen
  • Patients with no past- or present malignant tumors
  • Patients who are not currently receiving Humira

Exclusion Criteria:

  • Contraindications according to the Package Insert
  • Patients who have serious infections
  • Patients who have tuberculosis
  • Patients with a history of hypersensitivity to any ingredient of Humira
  • Patients who have demyelinating disease or with a history of demyelinating disease
  • Patients who have congestive cardiac failure
Sexes Eligible for Study: All
16 Years to 99 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01464333
P13-170
No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Undecided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: AbbVie Inc. AbbVie
AbbVie
January 2018