Improvement of Work Productivity and Quality of Life With Anti-TNF Therapies Used in Crohn's Disease in Routine Clinical Practice in Turkey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 主要终点
- Total Work Productivity Impairment (TWPI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Total Work Productivity Impairment (TWPI)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)