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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01464333
First received: November 1, 2011
Last updated: July 31, 2014
Last verified: July 2014

November 1, 2011
July 31, 2014
December 2011
March 2017   (final data collection date for primary outcome measure)
  • Number of patients with adverse events [ Time Frame: at month 6 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
Same as current
Complete list of historical versions of study NCT01464333 on ClinicalTrials.gov Archive Site
  • Crohn's Disease Activity Index [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at year 1 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at year 1.5 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at year 2 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at year 2.5 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at year 3 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1.5 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2.5 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 3 ] [ Designated as safety issue: No ]
Same as current
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
500
March 2017
March 2017   (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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01464333
P13-170
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Sadanori Abe AbbVie GK
AbbVie
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP