Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
1 de agosto de 2018 actualizado por: Amgen
An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept
The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Candidates for treatment are those who in the determination of the investigator's standard of care and the caring physician's intent are to initiate treatment with etanercept.
Participants must be naïve to etanercept and naïve to other autoinjector pens or prefilled syringes and be able to self-inject.
The study will consist of a 30 day screening period, and 2 treatment periods of 4 weeks duration each (one treatment period using Autoinjector A and the other using Autoinjector B).
At the end of the study, participants may continue treatment with commercially available etanercept at the physician's discretion.
Tipo de estudio
Intervencionista
Inscripción (Actual)
217
Fase
- Fase 4
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
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British Columbia
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Victoria, British Columbia, Canadá, V8V 3P9
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1C 5B8
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Ontario
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Barrie, Ontario, Canadá, L4M 7G1
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Burlington, Ontario, Canadá, L7R 1E2
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Courtice, Ontario, Canadá, L1E 3C3
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Hamilton, Ontario, Canadá, L8N 1Y2
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Mississauga, Ontario, Canadá, L5M 2V8
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Oakville, Ontario, Canadá, L6J 7W5
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Peterborough, Ontario, Canadá, K9J 1Z2
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Alabama
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Huntsville, Alabama, Estados Unidos, 35801
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Tuscaloosa, Alabama, Estados Unidos, 35406
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Arizona
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Glendale, Arizona, Estados Unidos, 85304
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Scottsdale, Arizona, Estados Unidos, 85258
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Arkansas
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Hot Springs, Arkansas, Estados Unidos, 71913
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California
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San Diego, California, Estados Unidos, 92108
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San Ramon, California, Estados Unidos, 94583
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Santa Maria, California, Estados Unidos, 93454-6945
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Tustin, California, Estados Unidos, 92780
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Colorado
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Denver, Colorado, Estados Unidos, 80230
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Florida
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Dunedin, Florida, Estados Unidos, 34698
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Tampa, Florida, Estados Unidos, 33614
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Kansas
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Overland Park, Kansas, Estados Unidos, 66215
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40217
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Maryland
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Frederick, Maryland, Estados Unidos, 21702
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Michigan
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Lansing, Michigan, Estados Unidos, 48910
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68516
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New York
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Orchard Park, New York, Estados Unidos, 14127
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58502
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Ohio
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Dayton, Ohio, Estados Unidos, 45417
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
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Pennsylvania
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Duncansville, Pennsylvania, Estados Unidos, 16635
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Wyomissing, Pennsylvania, Estados Unidos, 19610
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29414
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Tennessee
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Hixson, Tennessee, Estados Unidos, 37343
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Texas
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Austin, Texas, Estados Unidos, 78731
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Dallas, Texas, Estados Unidos, 75231
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West Virginia
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Clarksburg, West Virginia, Estados Unidos, 26301
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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: Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderate to severe Plaque Psoriasis (PsO) and a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept. - Naive to etanercept. - Naive to other autoinjector pens or prefilled syringes for Tumor Necrosis Factor (TNF)-inhibitor therapy or other subcutaneous biologics for RA. - Willing to self-inject per investigator judgement at screening and capable of self-injection using the autoinjector A or B as documented at baseline by the investigator. - Able to read and write in English. -
Exclusion Criteria: Latex allergy. - Subject has an active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept. - Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.
- Other 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 cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Autoinjector A
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
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Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.
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Experimental: Autoinjector B
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
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Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
Periodo de tiempo: Week 8
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Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question "Which autoinjector do you prefer overall?"
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Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Needle Apprehension at Week 4
Periodo de tiempo: Baseline and Week 4
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Participants' needle apprehension was assessed using the Subject's Perception of Self-Injecting Questionnaire.
Participants answered the question "Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector" using a scale from 1 (extremely nervous) to 5 (not at all nervous).
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Baseline and Week 4
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Ease of Use
Periodo de tiempo: At the end of each treatment period; Week 4 and Week 8
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Ease of use was assessed based on responses to questions 1 to 6 of the Subject's Experience with the Autoinjector Questionnaire: 1.
How easy was it to learn how to use the autoinjector?
2. How easy was it for you to press the button to start the injection?
3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection?
5. How easy was it for you to inject yourself using the autoinjector?
6.
How easy was it to follow the progress of the injection?
Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy).
The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.
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At the end of each treatment period; Week 4 and Week 8
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Certainty of Completing the Injection With the Autoinjector
Periodo de tiempo: At the end of each treatment period; Week 4 and Week 8
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Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject's Experience with the Autoinjector Questionnaire: "How certain were you that you knew when the injection was finished?"
Participants answered on a scale from 1 (Not at all) to 5 (Extremely).
The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Convenience
Periodo de tiempo: At the end of each treatment period; Week 4 and Week 8
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Convenience was assessed based on responses to Question 8 of the Subject's Experience with the Autoinjector Questionnaire: "How convenient was the autoinjector to use?" Participants answered on a scale from 1 (Not at all) to 5 (Very much).
The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Discomfort
Periodo de tiempo: At the end of each treatment period; Week 4 and Week 8
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Discomfort was assessed based on responses to Question 9 of the Subject's Experience with the Autoinjector Questionnaire: "How much discomfort did you experience when giving yourself the medicine using the autoinjector?"
Participants answered on a scale from 1 (None) to 5 (Very much).
The percentage of participants who scored a 1 (None) or 2 (A little) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Satisfaction
Periodo de tiempo: At the end of each treatment period; Week 4 and Week 8
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Satisfaction was assessed based on responses to questions 11 and 12 of the Subject's Experience with the Autoinjector Questionnaire.
Question 11: "How dependable (durable, sturdy, reliable) did you feel the autoinjector device was?" answered on a scale from 1 (Not at all) to 5 (Very much).
Question 12: "Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept?" answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend).
The percentage of participants who scored either a 4 or 5 on each question is reported.
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At the end of each treatment period; Week 4 and Week 8
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Pain Associated With Use of the Autoinjector
Periodo de tiempo: At the end of each treatment period; Week 4 and Week 8
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Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject's Experience with the Autoinjector Questionnaire: "Using this scale, select the circle that best describes how much it hurt when giving yourself an injection."
Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst).
The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Strength of Preference for Autoinjector A and Autoinjector B
Periodo de tiempo: Week 8
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Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8.
After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).
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Week 8
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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.
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)
5 de junio de 2013
Finalización primaria (Actual)
4 de marzo de 2014
Finalización del estudio (Actual)
4 de marzo de 2014
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2013
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2013
Publicado por primera vez (Estimar)
12 de junio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
1 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de la piel
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Enfermedades De La Piel Papuloescamosa
- Artritis
- Artritis Reumatoide
- 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
- 20090176
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
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