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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 enero de 2019 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

281

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • Quebec
      • Westmount, Quebec, Canadá, H3Z 1R7
        • Local Institution

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
Otro: No intervencionista
No intervencionista
RC Patients
RA patients managed with routine care(RC)
Otro: No intervencionista
No intervencionista

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of T2T patients achieving sustained CDAI LDA
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of patients achieving SDAI remission
Periodo de tiempo: 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
Periodo de tiempo: Up to 24 months
Length of time from treatment initiation SDAI remission
Up to 24 months
Number of patients achieving CDAI remission
Periodo de tiempo: 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
Periodo de tiempo: Up to 24 months
Length of time from treatment initiation CDAI remission
Up to 24 months
Number of patients achieving DAS28-CRP LDA
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 24 months
Length of time from treatment initiation to Boolean remission.
Up to 24 months
Number of patients achieving RAPID3 LDA
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 24 months
Assessed using simple Visual Analogue Scales (VAS)
Up to 24 months
Change from baseline in DAS28-CRP score
Periodo de tiempo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in CDAI score
Periodo de tiempo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in SDAI score
Periodo de tiempo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in RAPID3 score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in HAQ-DI score
Periodo de tiempo: 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
Periodo de tiempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Patient Pain
Periodo de tiempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Patient Fatigue
Periodo de tiempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Number of patients continuing treatment
Periodo de tiempo: At 12 months
Measured by investigator assessment
At 12 months
Number of patients continuing treatment
Periodo de tiempo: At 24 months
Measured by investigator assessment
At 24 months
Number of changes to Rheumatoid Arthritis (RA) treatment
Periodo de tiempo: Up to 24 months
Measured by investigator assessment
Up to 24 months
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
Periodo de tiempo: Up to 12 months
Measured by questionnaire
Up to 12 months
Incidence of treatment-emergent Adverse Events
Periodo de tiempo: Up to 24 months
Measured by investigator assessment
Up to 24 months
Time to achieve sustained CDAI LDA
Periodo de tiempo: Up to 12 Months
Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
Up to 12 Months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bristol-Myers Squibb

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de octubre de 2011

Finalización primaria (Actual)

31 de octubre de 2018

Finalización del estudio (Actual)

31 de octubre de 2018

Fechas de registro del estudio

Enviado por primera vez

5 de septiembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

5 de septiembre de 2017

Publicado por primera vez (Actual)

6 de septiembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de enero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

28 de enero de 2019

Última verificación

1 de enero de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IM101-331

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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