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Special Investigation in Patients With Crohn's Disease (All Patients Investigation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01298648
First received: January 26, 2011
Last updated: March 1, 2013
Last verified: February 2013
History of Changes

January 26, 2011
March 1, 2013
November 2010
February 2013   (final data collection date for primary outcome measure)
  • Number of patients with adverse events [ Time Frame: at week 24 ] [ 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
  • Crohn's Disease Activity Index [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01298648 on ClinicalTrials.gov Archive Site
Effectiveness evaluation by the investigator [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment
Same as current
Not Provided
Not Provided
 
Special Investigation in Patients With Crohn's Disease (All Patients Investigation)
Special Investigation (All Cases Investigation in Patients With Crohn's Disease)

This study of Humira will be conducted to clarify the following with regard to the treatment of Crohn's disease with this drug:

  • Unknown adverse drug reactions (especially important adverse drug reactions)
  • Incidence and conditions of occurrence of adverse reactions in the clinical setting
  • Factors that may affect the safety and effectiveness of Humira
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All patients who receive Humira for the treatment of Crohn's Disease
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.
 
Completed
1729
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients with moderate or severe active Crohn's disease who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

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
 
NCT01298648
P12-706
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Toshiro Maeda AbbVie GK
AbbVie
February 2013

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