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Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries

14. juni 2017 opdateret af: Bristol-Myers Squibb

Evaluation of the Effectiveness of the Abatacept (Orencia®) IV and SC Patient Alert Cards in Patients With Rheumatoid Arthritis in European Economic Area Countries

The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

3 sub studies: 2 Cross-Sectional and 1 retrospective chart review

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

203

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Abergavenny, Det Forenede Kongerige, NP7 7EG
        • Nevil Hall Hospital
      • Basingstoke, Det Forenede Kongerige, RG24 9NA
        • Local Institution
      • Derby, Det Forenede Kongerige, DE22 3NE
        • Royal Derby Hospital
      • Dewsbury, Det Forenede Kongerige, WF13 4HS
        • Barnsley Hospital NHS Foundation Trust
      • East Sussex, Det Forenede Kongerige, BN21 2UD
        • Eastbourne District Gen. Hosp.
      • Harlow, Det Forenede Kongerige, CM20 1QX
        • Princess Alexandra Hospital
      • Harlow, Det Forenede Kongerige, CM20 1QX
        • Local Institution
      • St. Helens, Det Forenede Kongerige, WA9 3DA
        • St Helens Hospital
      • Wirral, Det Forenede Kongerige, CH49 5PE
        • Arrow Park Hospital
  • Frankrig
      • Limoges, Frankrig, 87042
        • CHU Limoges - Hopital Dupuytren
      • Paris, Frankrig, 75571
        • APHM - Hopital Sainte-Marguerite, Marseille
  • Spanien
      • A Coruña, Spanien, 15006
        • Hospital Coruña
      • Barbastro, Spanien, 22300
        • Hospital Ccal. de Barbastro
      • Elche, Spanien, 3203
        • Hospital Elche
      • Elda, Spanien, 3600
        • Hospital Elda
      • Elda, Spanien, 3600
        • Local Institution
      • Getafe, Spanien, 28905
        • Hospital Getafe
      • Madrid, Spanien, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spanien, 28007
        • Local Institution
      • Merida, Spanien, 6800
        • Hospital Merida
      • Plasencia, Spanien, 10600
        • Hospital Virgen del Puerto
      • Plasencia, Spanien, 10600
        • Local Institution
      • Sevilla, Spanien, 41009
        • Hospital Virgen Macarena
      • Terrasa, Spanien, 8221
        • Hospital Mutua de Terrasa
  • Sverige
      • Malmö, Sverige, 20502
        • Local Institution
      • Solna, Sverige, 17176
        • Local Institution
  • Tyskland
      • Bad Kreuznach, Tyskland, 55543
        • Acura Kliniken
      • Bad Kreuznach, Tyskland, 55543
        • Local Institution
      • Bad Nauheim, Tyskland, 61231
        • Local Institution
      • Bad Nauheim, Tyskland, 61231
        • Bad Nauheim
      • Frankenberg, Tyskland, 9669
        • Local Institution
      • Heidelberg, Tyskland, 69120
        • Universitätsklinikum Heidelberg
      • Heidelberg, Tyskland, 69120
        • Local Institution
      • Heidelberg, Tyskland, 69121
        • Heidelberg
      • Zwickau, Tyskland, 8056
        • Local Institution
      • Zwickau, Tyskland, 8056
        • Zwickau

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Cohort 1: Patients enrolled by physician or nurse based in hospital rheumatology departments and physician clinics and offices

Cohort 2: Physician or nurse based in hospital RA department and physician clinics and offices

Cohort 3: Patients enrolled by physician or nurse based in hospital rheumatology departments and physician clinics and offices

Beskrivelse

Inclusion Criteria:

  • Patient survey (cohort 1):

    1. Patients has taken abatacept within the previous 3 months for rheumatoid arthritis
    2. Patient is 18 years of age or over

  • HCP survey (cohort 2):

    a) Physician or nurses working in rheumatology centers, with at least 1 patient taking abatacept in the previous 6 months for rheumatoid arthritis (by prescribing, administering or by follow up)

  • Retrospective chart review study (cohort 3):

    1. Patient survey questionnaire completed , Informed Consent Form (ICF) signed

Exclusion Criteria:

  • Patient survey:

    1. Patient has participated in a clinical trial for their arthritis in the previous 12 months
    2. Currently an employee of BMS

  • HCP survey:

    1. Physicians or nurse who have recruited patients for the Patient survey
    2. Currently an employee of BMS

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
Patients survey
Adult patients treated with abatacept for rheumatoid arthritis
HCP survey
HCP with at least 1 patient taking abatacept
Retrospective chart review study
Adult patients treated with abatacept for rheumatoid arthritis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
Tidsramme: At patient enrolment
At patient enrolment
Patient survey: Proportion of patients treated with abatacept who have received the PAC
Tidsramme: At patient enrolment
At patient enrolment
Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
Tidsramme: At patient enrolment
At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment
Tidsramme: At patient enrolment
At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment
Tidsramme: At patient enrolment
At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
Tidsramme: At patient enrolment
Objectives: distribution, awareness, utility, utilization and knowledge
At patient enrolment
Patient survey: Mean total score for correct responses
Tidsramme: At patient enrolment
At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC
Tidsramme: Day 1
Day 1
HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
Tidsramme: Day 1
Day 1
HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering abatacept
Tidsramme: Day 1
Day 1
HCP survey: Mean total score for correct responses
Tidsramme: Day 1
Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives
Tidsramme: Day 1
Objectives: distribution, awareness, utility, utilization and knowledge
Day 1
Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
Tidsramme: Approximately 3 months
Approximately 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients
Tidsramme: At patient enrolment

Determinants: Formulation of abatacept administered, country, age, gender,

educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration
At patient enrolment
Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients
Tidsramme: At patient enrolment

Determinants: Formulation of abatacept administered, country, age, gender,

educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration
At patient enrolment
Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients
Tidsramme: At patient enrolment

Determinants: Formulation of abatacept administered, country, age, gender,

educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration
At patient enrolment
Determinants of Health Care Professional (HCP) understanding, Implementation regarding key messages contained in the PAC based on data collected in the abatacept IV and SC formulation PACs among HCPs
Tidsramme: Day 1
Determinants: type of HCP, role of the HCP, country, age and sex of the HCP, years in the specialty, number of HCPs in the unit, annual number of patients managed by the unit, number of patients for whom abatacept was prescribed in the previous 12 months, type of practice, type of institution (academic or non-academic), size of town
Day 1
Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for Tuberculosis (TB) prior to administration of therapy of abatacept
Tidsramme: Upto 8 years
Upto 8 years
Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for viral hepatitis before administration of therapy with abatacept
Tidsramme: Upto 8 years
Upto 8 years
Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention
Tidsramme: Upto 8 years
Upto 8 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

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 (Faktiske)

29. november 2016

Primær færdiggørelse (Faktiske)

28. april 2017

Studieafslutning (Faktiske)

28. april 2017

Datoer for studieregistrering

Først indsendt

10. december 2015

Først indsendt, der opfyldte QC-kriterier

14. december 2015

Først opslået (Skøn)

17. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IM101-537

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 Rheumatoid arthritis

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CROs in Vietnam

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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