Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT01860846
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2017-02-06
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Results First Posted: 2017-06-16
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Male or female participants between 18-65 years of age with moderately to severely (Crohn's Disease Activity Index 220-450) active Crohn's Disease with or without fistula formation
• Participants who were able to provide authorization to use and disclose information related to the study
• Proven diagnosis of Crohn's Disease in accordance with international diagnostic criteria such as European Crohn's and Colitis Organization (ECCO) guidelines
• Participants for whom the physician had initiated anti-Tumor Necrosis Factor treatment in accordance with Turkish Ministry of Health regulations and reimbursements

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Exclusion Criteria

• Participants who had a history of any kind of biological therapy and/or anti-Tumor Necrosis Factor treatments for Crohn's Disease or other indications
• Participants who had septic complications (active infection and/or active tuberculosis (TB), undrained abscess)
• Participants who had bowel obstructions and fibrotic strictures
• Participants who had received any investigational drug within 30 days prior to the Visit 1 at baseline
• For any reason, participants who were considered by the investigator to be unsuitable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Work Productivity Impairment (TWPI)	At baseline and 12 months	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.
Total Activity Impairment (TAI)	At baseline and 12 months	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.
Work Productivity and Activity Index (WPAI): Absenteeism	At baseline and 12 months	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.
Work Productivity and Activity Index (WPAI): Presenteeism	At baseline and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Short Form 36 (SF-36) Health Survey Scores	At baseline and 12 months	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.
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores	At baseline and 12 months	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.
Change in Extra-intestinal Symptoms	At baseline and 12 months	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.
Number of Participants With Serious Adverse Events	From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks	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.