Trial Outcomes & Findings for Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease (NCT NCT01860846)

NCT ID: NCT01860846

Last Updated: 2017-06-16

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 106 participants
• Primary outcome timeframe: At baseline and 12 months
• Results posted on: 2017-06-16

Participant Flow

A total of 106 participants were enrolled in the study and were intended to be followed for 12 months.

Participant milestones

Measure	Participants With Moderate to Severe Crohn's Disease Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Overall Study STARTED	106
Overall Study Month 1	97
Overall Study Month 2	83
Overall Study Month 4	82
Overall Study Month 6	85
Overall Study Month 12	73
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Measure	Participants With Moderate to Severe Crohn's Disease Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Overall Study Lost to Follow-up	33

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Measure	Participants With Moderate to Severe Crohn's Disease n=106 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Age, Continuous	36.8 years STANDARD_DEVIATION 10.9 • n=106 Participants
Sex: Female, Male Female	38 Participants n=106 Participants
Sex: Female, Male Male	68 Participants n=106 Participants
Anti-TNF Treatments Adalimumab	78 Participants n=101 Participants • Participants with available data
Anti-TNF Treatments Infliximab	23 Participants n=101 Participants • Participants with available data

PRIMARY outcome

Timeframe: At baseline and 12 months

Population: Participants with available data

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.

Outcome measures

Measure	Participants With Moderate to Severe Crohn's Disease n=67 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Work Productivity and Activity Index (WPAI): Absenteeism Baseline	38.3 units on a scale Standard Deviation 39.0
Work Productivity and Activity Index (WPAI): Absenteeism 12 months	14.2 units on a scale Standard Deviation 27.0

PRIMARY outcome

Timeframe: At baseline and 12 months

Population: Participants with available data

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.

Outcome measures

Measure	Participants With Moderate to Severe Crohn's Disease n=58 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Work Productivity and Activity Index (WPAI): Presenteeism Baseline	39.8 units on a scale Standard Deviation 31.7
Work Productivity and Activity Index (WPAI): Presenteeism 12 months	21.8 units on a scale Standard Deviation 19.3

PRIMARY outcome

Timeframe: At baseline and 12 months

Population: Participants with available data

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.

Outcome measures

Measure	Participants With Moderate to Severe Crohn's Disease n=57 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Total Work Productivity Impairment (TWPI) Baseline	24.2 units on a scale Standard Deviation 21.2
Total Work Productivity Impairment (TWPI) 12 months	15.7 units on a scale Standard Deviation 16.4

PRIMARY outcome

Timeframe: At baseline and 12 months

Population: Participants with available data

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.

Outcome measures

Measure	Participants With Moderate to Severe Crohn's Disease n=105 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Total Activity Impairment (TAI) Baseline	47.0 units on a scale Standard Deviation 32.0
Total Activity Impairment (TAI) 12 months	30.0 units on a scale Standard Deviation 27.0

SECONDARY outcome

Timeframe: At baseline and 12 months

Population: Participants with available data

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.

Outcome measures

Measure	Participants With Moderate to Severe Crohn's Disease n=105 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Change in Short Form 36 (SF-36) Health Survey Scores Physical Functioning Score (Baseline)	62.8 units on a scale Standard Deviation 30.1
Change in Short Form 36 (SF-36) Health Survey Scores Physical Functioning Score (12 months)	81.2 units on a scale Standard Deviation 21.4
Change in Short Form 36 (SF-36) Health Survey Scores Role-Physical Score (Baseline)	29.3 units on a scale Standard Deviation 39.1
Change in Short Form 36 (SF-36) Health Survey Scores Role-Physical Score (12 months)	67.2 units on a scale Standard Deviation 41.5
Change in Short Form 36 (SF-36) Health Survey Scores Role-Emotional Score (Baseline)	35.2 units on a scale Standard Deviation 39.2
Change in Short Form 36 (SF-36) Health Survey Scores Role-Emotional Score (12 months)	62.8 units on a scale Standard Deviation 43.9
Change in Short Form 36 (SF-36) Health Survey Scores Vitality Score (Baseline)	46.9 units on a scale Standard Deviation 26.9
Change in Short Form 36 (SF-36) Health Survey Scores Vitality Score (12 months)	58.6 units on a scale Standard Deviation 20.8
Change in Short Form 36 (SF-36) Health Survey Scores Mental Health Score (Baseline)	53.6 units on a scale Standard Deviation 23.6
Change in Short Form 36 (SF-36) Health Survey Scores Mental Health Score (12 months)	63.0 units on a scale Standard Deviation 16.6
Change in Short Form 36 (SF-36) Health Survey Scores Social Functioning Score (Baseline)	58.6 units on a scale Standard Deviation 27.4
Change in Short Form 36 (SF-36) Health Survey Scores Social Functioning Score (12 months)	70.3 units on a scale Standard Deviation 22.6
Change in Short Form 36 (SF-36) Health Survey Scores Bodily Pain Score (Baseline)	51.9 units on a scale Standard Deviation 30.0
Change in Short Form 36 (SF-36) Health Survey Scores Bodily Pain Score (12 months)	73.0 units on a scale Standard Deviation 23.7
Change in Short Form 36 (SF-36) Health Survey Scores General Health Score (Baseline)	44.8 units on a scale Standard Deviation 22.2
Change in Short Form 36 (SF-36) Health Survey Scores General Health Score (12 months)	54.9 units on a scale Standard Deviation 19.7

SECONDARY outcome

Timeframe: At baseline and 12 months

Population: Participants with available data

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.

Outcome measures

Measure	Participants With Moderate to Severe Crohn's Disease n=105 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores Bowel-related Symptoms Score (Baseline)	4.5 units on a scale Standard Deviation 1.1
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores Bowel-related Symptoms Score (12 months)	5.2 units on a scale Standard Deviation 1.1
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores Systemic Symptoms Score (Baseline)	3.8 units on a scale Standard Deviation 1.4
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores Systemic Symptoms Score (12 months)	4.9 units on a scale Standard Deviation 1.1
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores Emotional Function Score (Baseline)	4.0 units on a scale Standard Deviation 1.1
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores Emotional Function Score (12 months)	4.7 units on a scale Standard Deviation 1.0
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores Social Function Score (Baseline)	4.3 units on a scale Standard Deviation 1.5
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores Social Function Score (12 months)	5.3 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: At baseline and 12 months

Population: Participants with available data

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.

Outcome measures

Measure	Participants With Moderate to Severe Crohn's Disease n=106 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Change in Extra-intestinal Symptoms Skeletal symptoms present (Baseline)	20 Participants
Change in Extra-intestinal Symptoms Skeletal symptoms present (12 months)	8 Participants
Change in Extra-intestinal Symptoms Dermatological symptoms present (Baseline)	7 Participants
Change in Extra-intestinal Symptoms Dermatological symptoms present (12 months)	3 Participants
Change in Extra-intestinal Symptoms Hepatobiliary symptoms present (Baseline)	0 Participants
Change in Extra-intestinal Symptoms Hepatobiliary symptoms present (12 months)	0 Participants
Change in Extra-intestinal Symptoms Ocular symptoms present (Baseline)	1 Participants
Change in Extra-intestinal Symptoms Ocular symptoms present (12 months)	0 Participants
Change in Extra-intestinal Symptoms Oral symptoms present (Baseline)	4 Participants
Change in Extra-intestinal Symptoms Oral symptoms present (12 months)	0 Participants

SECONDARY outcome

Timeframe: From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks

Population: All enrolled participants

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.

Outcome measures

Measure	Participants With Moderate to Severe Crohn's Disease n=106 Participants Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Number of Participants With Serious Adverse Events	2 Participants

Adverse Events

Participants With Moderate to Severe Crohn's Disease

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants With Moderate to Severe Crohn's Disease n=106 participants at risk Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
Infections and infestations Abdominal abscess	0.94% 1/106 • 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.
Infections and infestations Anal abscess	0.94% 1/106 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER