Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease (IDEA)
31. marts 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
106
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Participants with moderate to severe Crohn's Disease
Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Work Productivity and Activity Index (WPAI): Absenteeism
Tidsramme: 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.
|
At baseline and 12 months
|
|
Work Productivity and Activity Index (WPAI): Presenteeism
Tidsramme: 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.
|
At baseline and 12 months
|
|
Total Work Productivity Impairment (TWPI)
Tidsramme: 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.
|
At baseline and 12 months
|
|
Total Activity Impairment (TAI)
Tidsramme: 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.
|
At baseline and 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Short Form 36 (SF-36) Health Survey Scores
Tidsramme: 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.
|
At baseline and 12 months
|
|
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
Tidsramme: 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.
|
At baseline and 12 months
|
|
Change in Extra-intestinal Symptoms
Tidsramme: 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.
|
At baseline and 12 months
|
|
Number of Participants With Serious Adverse Events
Tidsramme: 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.
|
From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2013
Primær færdiggørelse (Faktiske)
1. februar 2016
Studieafslutning (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først indsendt
21. maj 2013
Først indsendt, der opfyldte QC-kriterier
21. maj 2013
Først opslået (Skøn)
23. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P13-338
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Crohns sygdom
-
Asan Medical CenterIkke rekrutterer endnuCrohns sygdom | Terapeutisk lægemiddelovervågning | Infliximab | Perianal fistel på grund af Crohns sygdom | Magnetic Resonance Novel Index for Fistel Imaging i Crohn's Disease Score