Special Investigation (Long-term Investigation) in Patients With Crohn's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Humira® for Subcutaneous Injection Protocol for Special Investigation (Long-term Treatment for Crohn's Disease Patients)

Conditions
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Crohn's Disease

Participation Criteria
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Eligibility Criteria
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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: None.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Humira<br>Participants who were prescribed Humira per approved prescribing information of Humira in Japan. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details. | From first dose of Humira up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Crohn's Disease Activity Index (CDAI) Score Over Time | The Change in Crohn's Disease Activity Index (CDAI) is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. A negative change from Baseline indicates improvement. | From first dose of Humira up to 3 years | 
| Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to CD) is calculated as the number of hours of work missed due to CD / (number of hours of work missed due to CD + number of hours worked) * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | From first dose of Humira up to 3 years | 
| Change in WPAI: CD Presenteeism Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to CD ) is calculated as the patient's rating of how much CD affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | From first dose of Humira up to 3 years | 
| Change in WPAI: CD Overall Work Impairment Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | From first dose of Humira up to 3 years | 
| Change in WPAI: CD Activity Impairment Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to CD ) is calculated as the patient's rating of how much CD affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | From first dose of Humira up to 3 years | 
| Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine) | Endoscopic remission per endoscopy sub score. | From first dose of Humira up to 3 years | 
| Change in C-Reactive Protein (CRP) Levels Over Time | CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation. | From first dose of Humira up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease