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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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

Studietype

Observasjonsmessig

Registrering (Faktiske)

203

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Limoges, Frankrike, 87042
        • CHU Limoges - Hôpital Dupuytren
      • Paris, Frankrike, 75571
        • APHM - Hopital Sainte-Marguerite, Marseille
  • Spania
      • A Coruña, Spania, 15006
        • Hospital Coruña
      • Barbastro, Spania, 22300
        • Hospital Ccal. de Barbastro
      • Elche, Spania, 3203
        • Hospital Elche
      • Elda, Spania, 3600
        • Hospital Elda
      • Elda, Spania, 3600
        • Local Institution
      • Getafe, Spania, 28905
        • Hospital Getafe
      • Madrid, Spania, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spania, 28007
        • Local Institution
      • Merida, Spania, 6800
        • Hospital Merida
      • Plasencia, Spania, 10600
        • Hospital Virgen Del Puerto
      • Plasencia, Spania, 10600
        • Local Institution
      • Sevilla, Spania, 41009
        • Hospital Virgen Macarena
      • Terrasa, Spania, 8221
        • Hospital Mutua De Terrasa
  • Storbritannia
      • Abergavenny, Storbritannia, NP7 7EG
        • Nevil Hall Hospital
      • Basingstoke, Storbritannia, RG24 9NA
        • Local Institution
      • Derby, Storbritannia, DE22 3NE
        • Royal Derby Hospital
      • Dewsbury, Storbritannia, WF13 4HS
        • Barnsley Hospital NHS Foundation Trust
      • East Sussex, Storbritannia, BN21 2UD
        • Eastbourne District Gen. Hosp.
      • Harlow, Storbritannia, CM20 1QX
        • Princess Alexandra Hospital
      • Harlow, Storbritannia, CM20 1QX
        • Local Institution
      • St. Helens, Storbritannia, WA9 3DA
        • St Helens Hospital
      • Wirral, Storbritannia, CH49 5PE
        • Arrow Park Hospital
  • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. november 2016

Primær fullføring (Faktiske)

28. april 2017

Studiet fullført (Faktiske)

28. april 2017

Datoer for studieregistrering

Først innsendt

10. desember 2015

Først innsendt som oppfylte QC-kriteriene

14. desember 2015

Først lagt ut (Anslag)

17. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IM101-537

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