- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02632890
Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries
Evaluation of the Effectiveness of the Abatacept (Orencia®) IV and SC Patient Alert Cards in Patients With Rheumatoid Arthritis in European Economic Area Countries
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bad Kreuznach, Alemania, 55543
- Acura Kliniken
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Bad Kreuznach, Alemania, 55543
- Local Institution
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Bad Nauheim, Alemania, 61231
- Local Institution
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Bad Nauheim, Alemania, 61231
- Bad Nauheim
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Frankenberg, Alemania, 9669
- Local Institution
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Heidelberg, Alemania, 69120
- Universitätsklinikum Heidelberg
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Heidelberg, Alemania, 69120
- Local Institution
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Heidelberg, Alemania, 69121
- Heidelberg
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Zwickau, Alemania, 8056
- Local Institution
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Zwickau, Alemania, 8056
- Zwickau
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A Coruña, España, 15006
- Hospital Coruña
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Barbastro, España, 22300
- Hospital Ccal. de Barbastro
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Elche, España, 3203
- Hospital Elche
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Elda, España, 3600
- Hospital Elda
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Elda, España, 3600
- Local Institution
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Getafe, España, 28905
- Hospital Getafe
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Madrid, España, 28007
- Hospital Gregorio Marañón
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Madrid, España, 28007
- Local Institution
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Merida, España, 6800
- Hospital Merida
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Plasencia, España, 10600
- Hospital Virgen del Puerto
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Plasencia, España, 10600
- Local Institution
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Sevilla, España, 41009
- Hospital Virgen Macarena
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Terrasa, España, 8221
- Hospital Mutua de Terrasa
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Limoges, Francia, 87042
- CHU Limoges - Hopital Dupuytren
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Paris, Francia, 75571
- APHM - Hopital Sainte-Marguerite, Marseille
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Abergavenny, Reino Unido, NP7 7EG
- Nevil Hall Hospital
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Basingstoke, Reino Unido, RG24 9NA
- Local Institution
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Derby, Reino Unido, DE22 3NE
- Royal Derby Hospital
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Dewsbury, Reino Unido, WF13 4HS
- Barnsley Hospital NHS Foundation Trust
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East Sussex, Reino Unido, BN21 2UD
- Eastbourne District Gen. Hosp.
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Harlow, Reino Unido, CM20 1QX
- Princess Alexandra Hospital
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Harlow, Reino Unido, CM20 1QX
- Local Institution
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St. Helens, Reino Unido, WA9 3DA
- St Helens Hospital
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Wirral, Reino Unido, CH49 5PE
- Arrow Park Hospital
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Malmö, Suecia, 20502
- Local Institution
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Solna, Suecia, 17176
- Local Institution
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
Descripción
Inclusion Criteria:
Patient survey (cohort 1):
- Patients has taken abatacept within the previous 3 months for rheumatoid arthritis
- 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):
- Patient survey questionnaire completed , Informed Consent Form (ICF) signed
Exclusion Criteria:
Patient survey:
- Patient has participated in a clinical trial for their arthritis in the previous 12 months
- Currently an employee of BMS
HCP survey:
- Physicians or nurse who have recruited patients for the Patient survey
- Currently an employee of BMS
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients survey
Adult patients treated with abatacept for rheumatoid arthritis
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HCP survey
HCP with at least 1 patient taking abatacept
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Retrospective chart review study
Adult patients treated with abatacept for rheumatoid arthritis
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
Periodo de tiempo: At patient enrolment
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At patient enrolment
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Patient survey: Proportion of patients treated with abatacept who have received the PAC
Periodo de tiempo: At patient enrolment
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At patient enrolment
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Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
Periodo de tiempo: At patient enrolment
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At patient enrolment
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Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment
Periodo de tiempo: At patient enrolment
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At patient enrolment
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Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment
Periodo de tiempo: At patient enrolment
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At patient enrolment
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Patient survey: Mean scores for correct responses for questions grouped by objectives
Periodo de tiempo: At patient enrolment
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Objectives: distribution, awareness, utility, utilization and knowledge
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At patient enrolment
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Patient survey: Mean total score for correct responses
Periodo de tiempo: At patient enrolment
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At patient enrolment
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HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC
Periodo de tiempo: Day 1
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Day 1
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HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
Periodo de tiempo: Day 1
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Day 1
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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
Periodo de tiempo: Day 1
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Day 1
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HCP survey: Mean total score for correct responses
Periodo de tiempo: Day 1
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Day 1
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HCP survey: Mean scores for correct responses for questions grouped by objectives
Periodo de tiempo: Day 1
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Objectives: distribution, awareness, utility, utilization and knowledge
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Day 1
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Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
Periodo de tiempo: Approximately 3 months
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Approximately 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients
Periodo de tiempo: At patient enrolment
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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
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Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients
Periodo de tiempo: At patient enrolment
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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
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Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients
Periodo de tiempo: At patient enrolment
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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
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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
Periodo de tiempo: Day 1
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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
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Day 1
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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
Periodo de tiempo: Upto 8 years
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Upto 8 years
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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
Periodo de tiempo: Upto 8 years
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Upto 8 years
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Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention
Periodo de tiempo: Upto 8 years
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Upto 8 years
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IM101-537
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