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This multicenter, prospective, post marketing observational study (PMOS) was designed to demonstrate long-term effects of anti-Tumor Necrosis Factor therapies on Work Productivity and Impairment scales in participants with moderate to severe Crohn's Disease (CD) under routine conditions. Secondary objectives of this study were long-term improvement of Quality of Life (QoL), evaluation of improvement of extraintestinal symptoms and comorbidities, and evaluation of safety.
Male or female participants between 18 - 65 years of age with moderate to severe CD for whom the treating physician had recently initiated an anti-TNF treatment were included in this study. Anti-TNF treatments were administered according to the treating physician's decision and applicable product label in Turkey. No interventions were made to the treatment and the participant discontinuance or to the follow-up decisions of the treating physician. Enrolled participants were observed for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with moderate to severe Crohn's Disease | Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Work Productivity and Activity Index (WPAI): Absenteeism | The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 2 asked participants to indicate the number of hours missed due to health problems in the past 7 days. Question 4 asked participants to indicate the number of hours that they worked in the past 7 days. Absenteeism (work time missed) was defined as the percentage of time absent from work due to health problems in the past week and was calculated by the formula Q2/(Q2 + Q4) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | At baseline and 12 months |
| Work Productivity and Activity Index (WPAI): Presenteeism | The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 to 10, with 0 indicating that health problems had no effect on their work and 10 indicating that health problems completely prevented the participant from working. Presenteeism (impairment at work) was calculated by the formula (Q5/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | At baseline and 12 months |
| Total Work Productivity Impairment (TWPI) | The Work Productivity and Activity Impairment: General Health (WPAI:GH) self-administered questionnaire was used to assess impairments in work due to symptoms of Crohn's Disease. Q2 asked participants the number of hours missed due to health problems in the past 7 days. Q4 asked participants the number of hours that they worked in the past 7 days. Q5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working). Total work productivity impairment (TWPI) is the combined absenteeism and presenteeism for employed participants, the percentage of overall work productivity lost due to health problems. TWPI was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))×(Q5/10)] × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Form 36 (SF-36) Health Survey Scores | The Short Form 36 (SF-36) Health Survey was used to determine participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item were summed and averaged (range = 0 "worst" to 100 "best"). Increases from baseline indicate improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Crohn's Disease who at the time of study entry were receiving anti-Tumor Necrosis Factor treatment as prescribed in accordance with Turkish Ministry of Health regulations and reimbursement conditions
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| Name | Affiliation | Role |
|---|---|---|
| Mahmut Gücük, MD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 106 participants were enrolled in the study and were intended to be followed for 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Moderate to Severe Crohn's Disease | Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Moderate to Severe Crohn's Disease | Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Work Productivity and Activity Index (WPAI): Absenteeism | The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 2 asked participants to indicate the number of hours missed due to health problems in the past 7 days. Question 4 asked participants to indicate the number of hours that they worked in the past 7 days. Absenteeism (work time missed) was defined as the percentage of time absent from work due to health problems in the past week and was calculated by the formula Q2/(Q2 + Q4) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | At baseline and 12 months |
|
From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks
Nonserious adverse events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Moderate to Severe Crohn's Disease | Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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Participants lost to follow-up were not replaced. Participant selection bias and lower number of participants completing questionnaires at later study visits.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| At baseline and 12 months |
| Total Activity Impairment (TAI) | The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 6 asked participants to indicate the degree to which their health affected their regular activities in the past 7 days. Total activity impairment is the percent impairment of non-work related activities due to health problems and was calculated with the formula (Q6/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | At baseline and 12 months |
| At baseline and 12 months |
| Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores | The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item self-administered questionnaire to measure health-related quality of life in adults with Crohn's Disease. The 32 items are grouped into subscales: bowel-related symptoms (10 items), systemic symptoms (5 items), social function (5 items), and emotional function (12 items). Responses to each item within each subscale range from 1 (significant impairment) to 7 (no impairment), and mean scores ranging from 1 to 7 are calculated for each subscale. Higher scores indicate a better quality of life. | At baseline and 12 months |
| Change in Extra-intestinal Symptoms | Extra-intestinal manifestations of Crohn's Disease (skeletal system [bones and muscle], dermatological [skin], hepatobiliary system [liver, gall bladder, and bile ducts], ocular [eyes] and oral [mouth]) were documented by the study investigators at each visit. | At baseline and 12 months |
| Number of Participants With Serious Adverse Events | A serious adverse event was defined as any untoward medical occurrence in a clinical investigation participant that met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion. | From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Anti-TNF Treatments | Participants with available data | Count of Participants | Participants |
|
Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment |
|
|
|
| Primary | Work Productivity and Activity Index (WPAI): Presenteeism | The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 to 10, with 0 indicating that health problems had no effect on their work and 10 indicating that health problems completely prevented the participant from working. Presenteeism (impairment at work) was calculated by the formula (Q5/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | At baseline and 12 months |
|
|
|
|
| Primary | Total Work Productivity Impairment (TWPI) | The Work Productivity and Activity Impairment: General Health (WPAI:GH) self-administered questionnaire was used to assess impairments in work due to symptoms of Crohn's Disease. Q2 asked participants the number of hours missed due to health problems in the past 7 days. Q4 asked participants the number of hours that they worked in the past 7 days. Q5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working). Total work productivity impairment (TWPI) is the combined absenteeism and presenteeism for employed participants, the percentage of overall work productivity lost due to health problems. TWPI was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))×(Q5/10)] × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | At baseline and 12 months |
|
|
|
|
| Primary | Total Activity Impairment (TAI) | The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 6 asked participants to indicate the degree to which their health affected their regular activities in the past 7 days. Total activity impairment is the percent impairment of non-work related activities due to health problems and was calculated with the formula (Q6/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | At baseline and 12 months |
|
|
|
|
| Secondary | Change in Short Form 36 (SF-36) Health Survey Scores | The Short Form 36 (SF-36) Health Survey was used to determine participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item were summed and averaged (range = 0 "worst" to 100 "best"). Increases from baseline indicate improvement. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | At baseline and 12 months |
|
|
|
|
| Secondary | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores | The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item self-administered questionnaire to measure health-related quality of life in adults with Crohn's Disease. The 32 items are grouped into subscales: bowel-related symptoms (10 items), systemic symptoms (5 items), social function (5 items), and emotional function (12 items). Responses to each item within each subscale range from 1 (significant impairment) to 7 (no impairment), and mean scores ranging from 1 to 7 are calculated for each subscale. Higher scores indicate a better quality of life. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | At baseline and 12 months |
|
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|
| Secondary | Change in Extra-intestinal Symptoms | Extra-intestinal manifestations of Crohn's Disease (skeletal system [bones and muscle], dermatological [skin], hepatobiliary system [liver, gall bladder, and bile ducts], ocular [eyes] and oral [mouth]) were documented by the study investigators at each visit. | Participants with available data | Posted | Count of Participants | Participants | At baseline and 12 months |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events | A serious adverse event was defined as any untoward medical occurrence in a clinical investigation participant that met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion. | All enrolled participants | Posted | Count of Participants | Participants | From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks |
|
|
|
| 2 |
| 106 |
| 0 |
| 0 |
| Anal abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007410 | Intestinal Diseases |
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| Role-Physical Score (Baseline) |
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| Role-Physical Score (12 months) |
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| Role-Emotional Score (Baseline) |
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| Role-Emotional Score (12 months) |
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| Vitality Score (Baseline) |
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| Vitality Score (12 months) |
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| Mental Health Score (Baseline) |
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| Mental Health Score (12 months) |
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| Social Functioning Score (Baseline) |
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| Social Functioning Score (12 months) |
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| Bodily Pain Score (Baseline) |
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| Bodily Pain Score (12 months) |
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| General Health Score (Baseline) |
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| General Health Score (12 months) |
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| Wilcoxon signed-ranked test |
| < 0.001 |
Baseline vs. 12 Months |
| Superiority or Other |
| Role-Emotional Scores: the null hypothesis was set as no difference. | Wilcoxon signed-ranked test | = 0.001 | Baseline vs. 12 Months | Superiority or Other |
| Vitality Scores: the null hypothesis was set as no difference. | Wilcoxon signed-ranked test | = 0.019 | Baseline vs. 12 Months | Superiority or Other |
| Mental Health Scores: the null hypothesis was set as no difference. | Wilcoxon signed-ranked test | = 0.017 | Baseline vs. 12 Months | Superiority or Other |
| Social Functioning Scores: the null hypothesis was set as no difference. | Wilcoxon signed-ranked test | = 0.007 | Baseline vs. 12 Months | Superiority or Other |
| Bodily Pain Scores: the null hypothesis was set as no difference. | Wilcoxon signed-ranked test | < 0.001 | Baseline vs. 12 Months | Superiority or Other |
| General Health Scores: the null hypothesis was set as no difference. | Wilcoxon signed-ranked test | = 0.005 | Baseline vs. 12 Months | Superiority or Other |
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| Systemic Symptoms Score (Baseline) |
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| Systemic Symptoms Score (12 months) |
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| Emotional Function Score (Baseline) |
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| Emotional Function Score (12 months) |
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| Social Function Score (Baseline) |
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| Social Function Score (12 months) |
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| Wilcoxon signed-ranked test |
| < 0.001 |
Baseline vs. 12 Months |
| Superiority or Other |
| Emotional Function Scores: the null hypothesis was set as no difference. | Wilcoxon signed-ranked test | < 0.001 | Baseline vs. 12 Months | Superiority or Other |
| Social Function Scores: The null hypothesis was set as no difference. | Wilcoxon signed-ranked test | < 0.001 | Baseline vs. 12 Months | Superiority or Other |
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| Dermatological symptoms present (Baseline) |
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| Dermatological symptoms present (12 months) |
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| Hepatobiliary symptoms present (Baseline) |
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| Hepatobiliary symptoms present (12 months) |
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| Ocular symptoms present (Baseline) |
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| Ocular symptoms present (12 months) |
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| Oral symptoms present (Baseline) |
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| Oral symptoms present (12 months) |
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