Know Cancer

or
forgot password

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


N/A
16 Years
N/A
Open (Enrolling)
Both
Crohn's Disease

Thank you

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

Name

Location