Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease (IDEA)
31. března 2017 aktualizováno: AbbVie
Improvement of Work Productivity and Quality of Life With Anti-TNF Therapies Used in Crohn's Disease in Routine Clinical Practice in Turkey
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
106
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 65 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Participants with moderate to severe Crohn's Disease
Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Work Productivity and Activity Index (WPAI): Absenteeism
Časové okno: At baseline and 12 months
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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.
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At baseline and 12 months
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Work Productivity and Activity Index (WPAI): Presenteeism
Časové okno: 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.
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At baseline and 12 months
|
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Total Work Productivity Impairment (TWPI)
Časové okno: At baseline and 12 months
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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.
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At baseline and 12 months
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Total Activity Impairment (TAI)
Časové okno: 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.
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At baseline and 12 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Short Form 36 (SF-36) Health Survey Scores
Časové okno: 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.
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At baseline and 12 months
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Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
Časové okno: At baseline and 12 months
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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.
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At baseline and 12 months
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Change in Extra-intestinal Symptoms
Časové okno: At baseline and 12 months
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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.
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At baseline and 12 months
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Number of Participants With Serious Adverse Events
Časové okno: From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks
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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.
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From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. května 2013
Primární dokončení (Aktuální)
1. února 2016
Dokončení studie (Aktuální)
1. února 2016
Termíny zápisu do studia
První předloženo
21. května 2013
První předloženo, které splnilo kritéria kontroly kvality
21. května 2013
První zveřejněno (Odhad)
23. května 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. června 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
31. března 2017
Naposledy ověřeno
1. března 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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