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- Ensayo clínico NCT00322439
Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
9 de mayo de 2018 actualizado por: Amgen
Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis
This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.
Descripción general del estudio
Descripción detallada
This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (Enbrel) use in the treatment of psoriasis.
Tipo de estudio
De observación
Inscripción (Actual)
2511
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 de probabilidad
Población de estudio
Patients with plaque psoriasis, who are currently receiving Enbrel or who are intending to start or restart Enbrel therapy at multi-centers.
Descripción
Inclusion Criteria:
- Patients with plaque psoriasis
Exclusion Criteria:
- Prior exposure to any tumor necrosis factor (TNF)-inhibitor
- Patients for whom Enbrel is contraindicated
- Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.
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
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Etanercept
Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals.
During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
|
Observational study - no drug administered
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events
Periodo de tiempo: 5 years
|
A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product.
This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept.
For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).
|
5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Five-year Cumulative Incidence for Events of Medical Interest (EMIs)
Periodo de tiempo: 5 years
|
Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance.
Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time).
Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.
|
5 years
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)
Periodo de tiempo: Baseline and at 3 and 5 years
|
The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema.
The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).
|
Baseline and at 3 and 5 years
|
Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1
Periodo de tiempo: Baseline and at 3 and 5 years
|
The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).
|
Baseline and at 3 and 5 years
|
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response
Periodo de tiempo: Baseline, Year 3 and Year 5
|
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings.
Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30.
A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.
|
Baseline, Year 3 and Year 5
|
Euroqol-5D (EQ-5D) Total Score
Periodo de tiempo: Baseline, Year 3 and Year 5
|
EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem.
Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health.
|
Baseline, Year 3 and Year 5
|
Euroqol-5D (EQ-5D) Visual Analog Scale (VAS)
Periodo de tiempo: Baseline, Year 3 and Year 5
|
The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'.
Participants were asked to indicate on this scale how good or bad their health was today.
|
Baseline, Year 3 and Year 5
|
Healthcare Resource Use
Periodo de tiempo: Baseline, Year 3 and Year 5
|
This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:
|
Baseline, Year 3 and Year 5
|
Work Productivity and Activity Impairment (WPAI)
Periodo de tiempo: Baseline, Year 3 and Year 5
|
The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days.
Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health.
Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes).
|
Baseline, Year 3 and Year 5
|
Percentage of Body Surface Area Affected by Psoriasis
Periodo de tiempo: Baseline, Year 3 and Year 5
|
Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.
|
Baseline, Year 3 and Year 5
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
Publicaciones Generales
- Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Creamer K, McCroskery P, Kricorian G, Gelfand JM. OBSERVE-5, an Observational Post-Marketing SafetySurveillance Registry of Etanercept for the treatment of Psoriasis: A Model for Studying New Psoriasis Therapies. Psoriasis Forum. 2010;16(3):3-7.
- Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Yong M, Creamer K, Hooper M, Aras G, Kricorian G, Gelfand JM. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013 May;68(5):756-64. doi: 10.1016/j.jaad.2012.10.055. Epub 2013 Jan 26.
- Kimball AB, Rothman KJ, Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, Rice KC, Gelfand JM. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015 Jan;72(1):115-22. doi: 10.1016/j.jaad.2014.08.050. Epub 2014 Sep 26.
- Kimball AB, Schenfeld J, Accortt NA, Anthony MS, Rothman KJ, Pariser D. Incidence rates of malignancies and hospitalized infectious events in patients with psoriasis with or without treatment and a general population in the U.S.A.: 2005-09. Br J Dermatol. 2014 Feb;170(2):366-73. doi: 10.1111/bjd.12744.
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)
1 de mayo de 2006
Finalización primaria (Actual)
11 de diciembre de 2012
Finalización del estudio (Actual)
8 de febrero de 2013
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2006
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2006
Publicado por primera vez (Estimar)
8 de mayo de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
9 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de la piel
- Enfermedades De La Piel Papuloescamosa
- Soriasis
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Gastrointestinales
- Etanercept
Otros números de identificación del estudio
- 20040210
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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. .
Ensayos clínicos sobre Soriasis
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ProgenaBiomeReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Rostro de psoriasis | Clavo de la psoriasis | Psoriasis difusa | Psoriasis Punctata | Psoriasis palmar | Psoriasis circinata | Psoriasis anular | Psoriasis genital | Psoriasis GeográficaEstados Unidos
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Centre of Evidence of the French Society of DermatologyReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Psoriasis palmar | Eritrodermia psoriásica | Uña psoriásica | Psoriasis en gotas | Psoriasis inversa | Psoriasis pustulosaFrancia
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Herlev and Gentofte HospitalReclutamientoInfarto de miocardio | Isquemia miocardica | Enfermedades cardíacas | Enfermedades cardiovasculares | Insuficiencia cardiaca | Carrera | Soriasis | Insuficiencia Cardíaca Diastólica | Psoriasis vulgar | Factor de riesgo cardiovascular | Insuficiencia Cardíaca Sistólica | Disfunción Ventricular Izquierda | Psoriasis... y otras condicionesDinamarca
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Clin4allReclutamientoPsoriasis del cuero cabelludo | Clavo de la psoriasis | Psoriasis palmar | Psoriasis genital | Psoriasis plantarFrancia
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UCB Biopharma S.P.R.L.TerminadoPsoriasis moderada a severa | Psoriasis Pustular Generalizada y Psoriasis EritrodérmicaJapón
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Innovaderm Research Inc.TerminadoPsoriasis del cuero cabelludo | Psoriasis pustulosa palmo-plantar | Psoriasis palmoplantar no pustulosa | Psoriasis de codo | Psoriasis de la parte inferior de la piernaCanadá
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TakedaReclutamientoPsoriasis pustulosa generalizada | Psoriasis eritrodérmicaJapón
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AmgenTerminadoPsoriasis tipo psoriasis | Psoriasis tipo placaEstados Unidos
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Assiut UniversityDesconocidoPacientes con psoriasis
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Shanghai Huaota Biopharmaceutical Co., Ltd.ReclutamientoPsoriasis pustulosa generalizada (PPG)Porcelana
Ensayos clínicos sobre Etanercept
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EMSRetirado
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Shanghai Celgen Bio-Pharmaceutical Co.,LtdDesconocidoSoriasis | Soriasis en placasPorcelana
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Sunshine Guojian Pharmaceutical (Shanghai) Co.,...TerminadoEspondiloartritis anquilosantePorcelana
-
AmgenTerminadoArtritis reumatoide; Artritis, PsoriásicaEstados Unidos, Puerto Rico
-
mAbxience Research S.L.Reclutamiento
-
AmgenTerminado
-
Samsung Bioepis Co., Ltd.TerminadoArtritis ReumatoidePolonia, Reino Unido
-
Sun Pharmaceutical Industries LimitedRetirado
-
Sun Yat-sen UniversityTerminado
-
AmgenTerminado