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

NCT01860846 | Completed Results

• 1 other identifier: P13-338
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  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

Secondary Outcomes (4)

• Change in Short Form 36 (SF-36) Health Survey Scores

  At baseline and 12 months

• Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores

  At baseline and 12 months

• Change in Extra-intestinal Symptoms

  At baseline and 12 months

• 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

Study Arms (1)

Participants with moderate to severe Crohn's Disease

Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Participants lost to follow-up were not replaced. Participant selection bias and lower number of participants completing questionnaires at later study visits.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Mahmut Gücük, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share