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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 de junho de 2017 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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

Tipo de estudo

Observacional

Inscrição (Real)

203

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
Prazo: At patient enrolment
At patient enrolment
Patient survey: Proportion of patients treated with abatacept who have received the PAC
Prazo: At patient enrolment
At patient enrolment
Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
Prazo: 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
Prazo: 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
Prazo: At patient enrolment
At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
Prazo: At patient enrolment
Objectives: distribution, awareness, utility, utilization and knowledge
At patient enrolment
Patient survey: Mean total score for correct responses
Prazo: 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
Prazo: Day 1
Day 1
HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
Prazo: 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
Prazo: Day 1
Day 1
HCP survey: Mean total score for correct responses
Prazo: Day 1
Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives
Prazo: Day 1
Objectives: distribution, awareness, utility, utilization and knowledge
Day 1
Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
Prazo: Approximately 3 months
Approximately 3 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Upto 8 years
Upto 8 years
Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention
Prazo: Upto 8 years
Upto 8 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Bristol-Myers Squibb

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de novembro de 2016

Conclusão Primária (Real)

28 de abril de 2017

Conclusão do estudo (Real)

28 de abril de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

10 de dezembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de dezembro de 2015

Primeira postagem (Estimativa)

17 de dezembro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de junho de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de junho de 2017

Última verificação

1 de junho de 2017

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IM101-537

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