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

• ClinicalTrials.gov Identifier: NCT01860846
• Recruitment Status: Completed
• First Posted: May 23, 2013
• Results First Posted: June 16, 2017
• Last Update Posted: June 16, 2017
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

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.

Condition or disease
Crohn's Disease

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 Design

• Study Type: Observational
• Actual Enrollment: 106 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Improvement of Work Productivity and Quality of Life With Anti-TNF Therapies Used in Crohn's Disease in Routine Clinical Practice in Turkey
• Study Start Date: May 2013
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Groups and Cohorts

Group/Cohort
Participants with moderate to severe Crohn's Disease; Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment

Outcome Measures

Primary Outcome Measures :

1. Work Productivity and Activity Index (WPAI): Absenteeism [ Time Frame: 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.
2. Work Productivity and Activity Index (WPAI): Presenteeism [ Time Frame: 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.
3. Total Work Productivity Impairment (TWPI) [ Time Frame: 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.
4. Total Activity Impairment (TAI) [ Time Frame: 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.

Secondary Outcome Measures :

1. Change in Short Form 36 (SF-36) Health Survey Scores [ Time Frame: 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.
2. Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores [ Time Frame: 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.
3. Change in Extra-intestinal Symptoms [ Time Frame: 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.
4. Number of Participants With Serious Adverse Events [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: Mahmut Gücük, MD; AbbVie

More Information

Additional Information:

Related Info 

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT01860846
• Other Study ID Numbers: P13-338
• First Posted: May 23, 2013
• Results First Posted: June 16, 2017
• Last Update Posted: June 16, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by AbbVie:

Crohn's Disease

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases