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: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (Long-term Investigation) in Patients With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: December 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
those with an exposure

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Those who are receiving Humira in accordance with its indications for treatment and dosage regimens.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464333

  Show 102 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sadanori Abe AbbVie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01464333     History of Changes
Other Study ID Numbers: P13-170
Study First Received: November 1, 2011
Last Updated: April 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 01, 2014