Trial Information
Special Investigation on Long-term Treatment in Patients With Crohn's Disease
Inclusion Criteria:
Patients who meet the following criteria at baseline will be evaluated in the
investigation;
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of patients with adverse events
Outcome Description:
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
Outcome Time Frame:
at month 6
Safety Issue:
Yes
Principal Investigator
Toshiro Maeda
Investigator Role:
Study Director
Investigator Affiliation:
AbbVie GK
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
P13-170
NCT ID:
NCT01464333
Start Date:
December 2011
Completion Date:
March 2017
Related Keywords:
- Crohn's Disease
- Crohn's Disease
- Crohn Disease