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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01464333
Recruitment Status : Active, not recruiting
First Posted : November 3, 2011
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Crohn's Disease

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
Study Start Date : December 16, 2011
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Humira
those with an exposure


Outcome Measures

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: at month 6 ]
    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

  2. Number of patients with adverse events [ Time Frame: at year 1 ]
    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

  3. Number of patients with adverse events [ Time Frame: at year 1.5 ]
    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

  4. Number of patients with adverse events [ Time Frame: at year 2 ]
    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

  5. Number of patients with adverse events [ Time Frame: at year 2.5 ]
    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

  6. Number of patients with adverse events [ Time Frame: at year 3 ]
    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 :
  1. Crohn's Disease Activity Index [ Time Frame: at week 4 ]
  2. Crohn's Disease Activity Index [ Time Frame: at month 3 ]
  3. Crohn's Disease Activity Index [ Time Frame: at month 6 ]
  4. Crohn's Disease Activity Index [ Time Frame: at year 1 ]
  5. Crohn's Disease Activity Index [ Time Frame: at year 1.5 ]
  6. Crohn's Disease Activity Index [ Time Frame: at year 2 ]
  7. Crohn's Disease Activity Index [ Time Frame: at year 2.5 ]
  8. Crohn's Disease Activity Index [ Time Frame: at year 3 ]
  9. Work Productivity and Activity Impairment Questionnaire [ Time Frame: at week 4 ]
  10. Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 3 ]
  11. Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 6 ]
  12. Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1 ]
  13. Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1.5 ]
  14. Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2 ]
  15. Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2.5 ]
  16. Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 3 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464333


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

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01464333     History of Changes
Other Study ID Numbers: P13-170
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Crohn's Disease

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