Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT01464333
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 511
- 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
- None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events From first dose of Humira up to 3 years 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine) From first dose of Humira up to 3 years Endoscopic remission per endoscopy sub score.
Change in C-Reactive Protein (CRP) Levels Over Time From first dose of Humira up to 3 years CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.
Change in Crohn's Disease Activity Index (CDAI) Score Over Time From first dose of Humira up to 3 years 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.
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time From first dose of Humira up to 3 years 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.
Change in WPAI: CD Overall Work Impairment Over Time From first dose of Humira up to 3 years 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.
Change in WPAI: CD Presenteeism Over Time From first dose of Humira up to 3 years 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.
Change in WPAI: CD Activity Impairment Over Time From first dose of Humira up to 3 years 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.