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Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis (REFINE)

7 de febrero de 2017 actualizado por: Amgen

A Randomized, Blinded Assessor Study to Evaluate the Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent Versus Etanercept 50 mg Twice Weekly in Subjects With Moderate to Severe Plaque Psoriasis

To estimate the difference in effectiveness between treatment with etanercept 50 mg twice weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN) topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The recommended starting dose of etanercept for adult plaque psoriasis patients is a 50 mg dose given twice a week (BIW) for 3 months followed by a reduction to a maintenance dose of 50 mg once weekly (QW). While most patients with moderate to severe plaque psoriasis are managed satisfactorily on etanercept monotherapy, a proportion may require a modified or alternative treatment regimen (eg, to handle flares or loss of effect) at some point during their chronic management. Despite the clinical need, no published data from randomized controlled studies are currently available that demonstrate efficacy and safety of combined etanercept-based regimens in patients with plaque psoriasis.

The addition of an as-needed topical medication to the step-down dose of etanercept 50 mg once weekly administered after the initial 12 week period of 50 mg twice weekly may be a potential option for patients who may require adjunctive therapy. This study aimed to provide data on this treatment option by estimating the difference in mean percent change in Psoriasis Area and Severity Index (PASI) scores between step-down etanercept 50 mg once weekly supplemented with as-needed topical medication and continuous treatment with etanercept 50 mg twice weekly.

Eligible patients will be enrolled in the study and will receive etanercept 50 mg twice weekly for 12 weeks. After 12 weeks of etanercept treatment, participants will be randomized in a 1:1 ratio to 1 of 2 treatment groups.

Tipo de estudio

Intervencionista

Inscripción (Actual)

310

Fase

  • Fase 3

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, Canadá, G1V 4X7
        • Research Site
      • Quebec, Canadá, G1J 1X7
        • Research Site
    • Alberta
      • Calgary, Alberta, Canadá, T2G 1B1
        • Research Site
    • British Columbia
      • Surrey, British Columbia, Canadá, V3R 6A7
        • Research Site
      • Vancouver, British Columbia, Canadá, V5Z 4E8
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3C 0N2
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canadá, E1C 8X3
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canadá, A1A 5E8
        • Research Site
      • St. John's, Newfoundland and Labrador, Canadá, A1C 2H5
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 1Z4
        • Research Site
    • Ontario
      • Courtice, Ontario, Canadá, L1E 3C3
        • Research Site
      • Markham, Ontario, Canadá, L3P 1A8
        • Research Site
      • Mississauga, Ontario, Canadá, L5H 1G9
        • Research Site
      • North Bay, Ontario, Canadá, P1B 3Z7
        • Research Site
      • Peterborough, Ontario, Canadá, K9J 1Z2
        • Research Site
      • Richmond Hill, Ontario, Canadá, L4B 1A5
        • Research Site
      • Sudbury, Ontario, Canadá, P3C 1X8
        • Research Site
      • Toronto, Ontario, Canadá, M3H 5Y8
        • Research Site
      • Toronto, Ontario, Canadá, M4V 1R1
        • Research Site
      • Waterloo, Ontario, Canadá, N2J 1C4
        • Research Site
      • Windsor, Ontario, Canadá, N8W 5L7
        • Research Site
    • Quebec
      • Montreal, Quebec, Canadá, H2K 4L5
        • Research Site
      • Montreal, Quebec, Canadá, H3Z 2S6
        • Research Site
      • Saint-Hyacinthe, Quebec, Canadá, J2S 6L6
        • Research Site

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

Descripción

Inclusion Criteria:

  • Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
  • Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
  • Is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
  • Other inclusion criteria may apply.

Exclusion Criteria:

  • Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
  • Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept on psoriasis.
  • Diagnosed with medication-induced or medication-exacerbated psoriasis.
  • Significant concurrent medical conditions.
  • Has any active localized infection; requiring local intervention or chronic or localized infections.
  • Other exclusion criteria may apply.

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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Etanercept 50 mg BIW
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks.
Biológico: etanercept
Administered by subcutaneous injection
Otros nombres:
  • Enbrel
Experimental: Etanercept 50 mg QW + Topical
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.
Biológico: etanercept
Administered by subcutaneous injection
Otros nombres:
  • Enbrel
Droga: Topical agents

Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following:

  • hydrocortisone 2.5%
  • betamethasone valerate 0.1%
  • betamethasone dipropionate 0.05%
  • clobetasol 0.05%
  • calcitriol
  • calcipotriol plus betamethsone dipropionate 0.05%

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24
Periodo de tiempo: Week 12 and Week 24
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value * 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.
Week 12 and Week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent Change in PASI From Week 12 to Weeks 16 and 20
Periodo de tiempo: Week 12, Week 16 and Week 20
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.
Week 12, Week 16 and Week 20
Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24
Periodo de tiempo: Baseline and Weeks 12, 16, 20, and 24
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.
Baseline and Weeks 12, 16, 20, and 24
Percentage of Participants With a PASI 50 Response
Periodo de tiempo: Baseline and Weeks 12, 16, 20 and 24
The percentage of participants with a 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Baseline and Weeks 12, 16, 20 and 24
Percentage of Participants With a PASI 75 Response
Periodo de tiempo: Baseline and Weeks 12, 16, 20 and 24
The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Baseline and Weeks 12, 16, 20 and 24
Percentage of Participants With a PASI 90 Response
Periodo de tiempo: Baseline and Weeks 12, 16, 20 and 24
The percentage of participants with a 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Baseline and Weeks 12, 16, 20 and 24
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)
Periodo de tiempo: Weeks 12, 16, 20, and 24
The sPGA scale is completed by the same blinded assessor performing the PASI assessments and 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).
Weeks 12, 16, 20, and 24
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24
Periodo de tiempo: Weeks 12, 16, 20, and 24

The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Week 12 is presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement.

Change was adjusted for treatment using a mixed model.
Weeks 12, 16, 20, and 24
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24
Periodo de tiempo: Baseline and Weeks 12, 16, 20, and 24

The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments.

Change from Baseline \ is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.
Baseline and Weeks 12, 16, 20, and 24
Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score
Periodo de tiempo: Week 12 and Week 24
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. Change from Week 12 to Week 24 is calculated as: Week 12 value - Week 24 value so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.
Week 12 and Week 24
Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score
Periodo de tiempo: Baseline and Week 12 and Week 24
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. Change from Baseline was calculated as Baseline value - postbaseline value so that a positive change indicates improvement.
Baseline and Week 12 and Week 24
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24
Periodo de tiempo: Week 12 and Week 24
TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as Week 24 - Week 12 so that a positive change indicates improvement over time. Change was adjusted for treatment using a mixed model.
Week 12 and Week 24
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24
Periodo de tiempo: Baseline and Weeks 12 and 24
The TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as postbaseline value - Baseline value so that a positive change indicates improvement.
Baseline and Weeks 12 and 24
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider
Periodo de tiempo: Baseline and 24 weeks
Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of visits to a healthcare provider, participants answered the following questions regarding the past 4 weeks: How many times have you been to any physician's office or urgent care clinic? How many times have you seen a nurse practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP)? The number of participants with one or more visits is reported.
Baseline and 24 weeks
Health Resource Utilization: Number of Participants With Home Healthcare Visits
Periodo de tiempo: Baseline and 24 weeks
Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of homecare visits, participants answered the following question regarding the past 4 weeks: How many times have you received care from a health professional in your home? The number of participants with one or more visits is reported.
Baseline and 24 weeks
Health Resource Utilization: Number of Participants Requiring Paid Help With Chores
Periodo de tiempo: Baseline and 24 weeks
Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of participants who needed paid help with chores, participants answered the following question regarding the past 4 weeks: How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)? The number of participants who paid for help one or more times is reported.
Baseline and 24 weeks
Health Resource Utilization: Number of Participants Who Needed Friend or Family Care
Periodo de tiempo: Baseline and 24 weeks
Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants answered the following question regarding the past 4 weeks: How many hours have you had a friend or family member take time off work to provide care or transportation? The number of participants who had paid or non-paid help for one or more hours is reported.
Baseline and 24 weeks
Health Resource Utilization: Out of Pocket Expenses
Periodo de tiempo: Baseline and 24 weeks
Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess out of pocket expenses, participants answered the following question regarding the past 4 weeks: Not counting study mandated visits, what out-of-pocket expenses did you spend for the management of psoriasis (i.e. costs due to travelling to doctor appointment, hospital or clinic parking costs, alternative medications)?
Baseline and 24 weeks
Health Resource Utilization: Employment Status
Periodo de tiempo: Baseline and 24 weeks
Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants were asked their employment status at Baseline and at Week 24.
Baseline and 24 weeks
Health Resource Utilization: Productivity While Working
Periodo de tiempo: Baseline and 24 weeks
Participants who were employed were asked: How much did your psoriasis affect your productivity while you were working? Possible responses were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.
Baseline and 24 weeks
Health Resource Utilization: Number of Participants With Missed Hours From Work
Periodo de tiempo: Baseline and 24 weeks
Participants who were employed answered the following question regarding the past 4 weeks: How many hours per week did you miss from work because of your psoriasis? The number of participants with one or more missed hours of work per week is reported.
Baseline and 24 weeks
Health Resource Utilization: Ability to Perform Daily Activities
Periodo de tiempo: Baseline and 24 weeks
Participants were asked: How much did your psoriasis affect your ability to do your daily activities or household chores? Possible answers were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.
Baseline and 24 weeks
Number of Participants With Adverse Events
Periodo de tiempo: 32 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard.
32 weeks

Colaboradores e Investigadores

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

Patrocinador

Amgen

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

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

1 de abril de 2011

Finalización primaria (Actual)

1 de diciembre de 2012

Finalización del estudio (Actual)

1 de mayo de 2013

Fechas de registro del estudio

Enviado por primera vez

24 de febrero de 2011

Primero enviado que cumplió con los criterios de control de calidad

10 de marzo de 2011

Publicado por primera vez (Estimar)

11 de marzo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de marzo de 2017

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

7 de febrero de 2017

Última verificación

1 de febrero de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20090647

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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