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Comparing the Effectiveness of a Treat-to-target (T2T) Disease Management Strategy vs. Routine Care (RC) in Adult Patients With Moderate to Severe Rheumatoid Arthritis (RA) Treated With Subcutaneous Abatacept (Orencia - SC) (ABC)

28 de janeiro de 2019 atualizado por: Bristol-Myers Squibb

The Abatacept Best Care (ABC) Trial

This is a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to participate in a 12-month extension of their follow-up provided that this is in agreement with the judgment of the treating physician.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Real)

281

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

  • Canadá
    • Quebec
      • Westmount, Quebec, Canadá, H3Z 1R7
        • 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 Não Probabilística

População do estudo

Adult patients with active RA defined as a CDAI > 10 for whom the treating physician has made the decision to initiate treatment with SC abatacept according to the approved Canadian product monograph and regional reimbursement criteria will be potentially eligible for inclusion in the study. The decision to treat the patient with SC abatacept must have been reached prior to and independently of considering the patient for study enrollment.

Descrição

Inclusion Criteria:

  • 18 years of age or older.
  • Active moderate to severe RA, defined as CDAI > 10.
  • The treating physician has made the decision to initiate treatment with SC abatacept in accordance with the Canadian product monograph.
  • Patient has provided a written informed consent and is able to complete the survey requirements.
  • Patient fulfills the reimbursement criteria for treatment with SC abatacept under provincial or private health insurance reimbursement coverage.

Exclusion Criteria:

  • Has received abatacept (SC or IV) prior to the enrolment visit.
  • Has failed more than one prior biologic DMARD therapy
  • Has a history of autoimmune disease or of any joint inflammatory disease other than RA with the exception of concomitant secondary Sjogren's syndrome.
  • Is participating in an ongoing clinical trial and/or has received treatment with an investigational agent within 4 weeks before starting treatment with SC abatacept.
  • Is participating in another industry-sponsored observational study.
  • Patients participating to non-industry related registries or other data collection studies can be included
  • Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of RA treatment.

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
Intervenção / Tratamento
T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
Outro: Não Intervencionista
Não Intervencionista
RC Patients
RA patients managed with routine care(RC)
Outro: Não Intervencionista
Não Intervencionista

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of T2T patients achieving sustained CDAI LDA
Prazo: Approximately 1 year
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
Approximately 1 year
Number of RC patients achieving sustained CDAI LDA
Prazo: Approximately 1 year
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
Approximately 1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of patients achieving SDAI remission
Prazo: Up to 24 months
Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3
Up to 24 months
Mean time for patients to achieve SDAI remission
Prazo: Up to 24 months
Length of time from treatment initiation SDAI remission
Up to 24 months
Number of patients achieving CDAI remission
Prazo: Up to 24 months
Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8
Up to 24 months
Mean time for patients to achieve CDAI remission
Prazo: Up to 24 months
Length of time from treatment initiation CDAI remission
Up to 24 months
Number of patients achieving DAS28-CRP LDA
Prazo: Up to 24 months
Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2
Up to 24 months
Mean time for patients to achieve DAS28-CRP LDA
Prazo: Up to 24 months
Length of time from treatment initiation to a DAS28-CRP score of less than 3.2
Up to 24 months
Number of patients achieving DAS28-CRP remission
Prazo: Up to 24 months
Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6
Up to 24 months
Mean time for patients to achieve DAS28-CRP remission
Prazo: Up to 24 months
Length of time from treatment initiation to a DAS28-CRP score of less than 2.6
Up to 24 months
Number of patients achieving Boolean remission
Prazo: Up to 24 months
Boolean remission is defined as TJC28 ≤1 and SJC28 ≤1 and CRP ≤1 mg/dl and PtGA ≤1 (on a 0-10 scale)
Up to 24 months
Mean time for patients to achieve Boolean remission
Prazo: Up to 24 months
Length of time from treatment initiation to Boolean remission.
Up to 24 months
Number of patients achieving RAPID3 LDA
Prazo: Up to 24 months
Routine Assessment of Patient Index Data 3 (RAPID3) Low Disease Activity (LDA) is achieved when RAPID3 score is less than or equal to 6.
Up to 24 months
Mean time for patients to achieve RAPID3 LDA
Prazo: Up to 24 months
Length of time from treatment initiation to a RAPID3 score of less than or equal to 6
Up to 24 months
Number of patients achieving RAPID3 remission
Prazo: Up to 24 months
Routine Assessment of Patient Index Data 3 (RAPID3) remission is achieved when RAPID3 score is less than or equal to 3.
Up to 24 months
Mean time for patients to achieve RAPID3 remission
Prazo: Up to 24 months
Length of time from treatment initiation to a RAPID3 score of less than or equal to 3
Up to 24 months
Number of patients achieving MCID in HAQ-DI
Prazo: Up to 24 months
minimal clinically important difference (MCID; Δ ≥ 0.22, ≥0.25, and ≥0.5) in Health Assessment Questionnaire Disability Index (HAQ-DI)
Up to 24 months
Mean time for patients to achieve MCID in HAQ-DI
Prazo: Up to 24 months
Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI
Up to 24 months
Number of patients achieving clinically meaningful improvement
Prazo: Up to 24 months
Number of patients achieving clinically meaningful improvement as measured by a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
Up to 24 months
Mean time for patients to achieve clinically meaningful improvement
Prazo: Up to 24 months
Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
Up to 24 months
Number of patients achieving patient expectations for treatment of their RA
Prazo: Up to 24 months
Assessed using simple Visual Analogue Scales (VAS)
Up to 24 months
Change from baseline in DAS28-CRP score
Prazo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in CDAI score
Prazo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in SDAI score
Prazo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in RAPID3 score
Prazo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in Tender Joint Count of 28 joints (TJC28) score
Prazo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
Prazo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in HAQ-DI score
Prazo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Work Productivity and Activity Impairment (WPAI) score
Prazo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Patient Pain
Prazo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Patient Fatigue
Prazo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Number of patients continuing treatment
Prazo: At 12 months
Measured by investigator assessment
At 12 months
Number of patients continuing treatment
Prazo: At 24 months
Measured by investigator assessment
At 24 months
Number of changes to Rheumatoid Arthritis (RA) treatment
Prazo: Up to 24 months
Measured by investigator assessment
Up to 24 months
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
Prazo: Up to 12 months
Measured by questionnaire
Up to 12 months
Incidence of treatment-emergent Adverse Events
Prazo: Up to 24 months
Measured by investigator assessment
Up to 24 months
Time to achieve sustained CDAI LDA
Prazo: Up to 12 Months
Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
Up to 12 Months

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)

31 de outubro de 2011

Conclusão Primária (Real)

31 de outubro de 2018

Conclusão do estudo (Real)

31 de outubro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

5 de setembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de setembro de 2017

Primeira postagem (Real)

6 de setembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de janeiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de janeiro de 2019

Última verificação

1 de janeiro de 2019

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IM101-331

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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