Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
22 de enero de 2019 actualizado por: Hoffmann-La Roche
Tocilizumab Real-Life Human Factors Validation Study
This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD).
The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2.
Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
91
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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Arizona
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Mesa, Arizona, Estados Unidos, 85202
- Arizona Arthritis and Rheuma
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California
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Los Alamitos, California, Estados Unidos, 90720
- Valerius Medical Group & Research Ctr of Greater Long Beach
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Santa Maria, California, Estados Unidos, 93454
- Pacific Arthritis Ctr Med Grp
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40515
- Bluegrass Comm Research, Inc.
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74104
- Oklahoma Center For Arthritis Therapy & Research
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Pennsylvania
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Duncansville, Pennsylvania, Estados Unidos, 16635
- Altoona Center for Clinical Research
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Wexford, Pennsylvania, Estados Unidos, 15090
- Advanced Rheumatology & Arthritis Research Center
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Texas
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Dallas, Texas, Estados Unidos, 75231
- Metroplex Clinical Research
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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:
- Participants with RA for greater than or equal to (>/=6) months receiving 162 mg tocilizumab PFS-NSD for >/=8 weeks and who are suitable for continued treatment at their currently prescribed dose
- CGs and professionally qualified HCPs who are able and willing to administer the injection
Exclusion Criteria:
- RA: Functional status Class IV
- RA: Neuropathies or other conditions that might interfere with pain evaluation
- RA: Pregnant or breastfeeding
- RA: Low neutrophil or platelet count at last laboratory assessment
- RA: Elevated liver enzymes at last laboratory assessment
- Current participation in another interventional clinical trial
- Criteria that might give the participant/CG/HCP an advantage in injection tasks such as employment in the pharmaceutical industry, etc.
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: Viabilidad del dispositivo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Caregivers
CGs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device.
Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.
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Tocilizumab will be administered using the AI-1000 G2.
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28).
The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Otros nombres:
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Experimental: Healthcare Professionals
HCPs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device.
Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided.
Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.
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Tocilizumab will be administered using the AI-1000 G2.
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28).
The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Otros nombres:
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Experimental: RA Group 1 (Self-Administration)
Participants with RA will perform self-injection of SC tocilizumab with the AI-1000 G2 device.
Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.
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Tocilizumab will be administered using the AI-1000 G2.
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28).
The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Otros nombres:
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Otro: RA Group 2 (Administration by CG)
CGs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device.
Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.
|
Tocilizumab will be administered using the AI-1000 G2.
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28).
The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Otros nombres:
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Otro: RA Group 3 (Administration by HCP)
HCPs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device.
Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided.
Visit 1 (Day 0) will be performed by the study nurse.
Visits 2 and 3 (Days 14 and 28) will be conducted by the HCP for use/performance evaluation.
|
Tocilizumab will be administered using the AI-1000 G2.
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28).
The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
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 Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Periodo de tiempo: Day 14
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Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention.
Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use.
Essential tasks included those essential to the execution of the injection.
Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered.
The percentage of participants who successfully performed safety-critical and essential tasks during the first unassisted use (Day 14) was reported.
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Day 14
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Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Periodo de tiempo: Day 28
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Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention.
Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use.
Essential tasks included those essential to the execution of the injection.
Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered.
The percentage of participants who successfully performed safety-critical and essential tasks during the second unassisted use (Day 28) was reported.
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Day 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
Periodo de tiempo: Days 14, 28
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Ancillary tasks included those tasks where the potential harm resulting from use error would be minor in severity, or the resultant harms were estimated to occur at sufficiently low levels.
Ancillary tasks included the following: wash hands; clean the injection site with alcohol swab; wait for the alcohol to dry; dispose of the autoinjector cap; inspect full dose delivered after use; dispose of the autoinjector; and treatment of injection site after injection.
The percentage of participants who succesffully performed ancillary tasks during the first (Day 14) and second unassisted use (Day 28) was reported.
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Days 14, 28
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Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
Periodo de tiempo: 0 and 15 minutes after injection on Days 0, 14, 28
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Injection pain was assessed on a continuous 100-millimeter (mm) VAS, where 0 mm represents "no pain" and 100 mm represents "unbearable pain".
The mean VAS response at each assessment timepoint was reported among participants with RA.
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0 and 15 minutes after injection on Days 0, 14, 28
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Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
Periodo de tiempo: 0 and 15 minutes after injection on Days 0, 14, 28
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Injection pain was assessed on a categorical 6-point Likert scale, ranging from "no pain" to "severe and intolerable".
The percentage of participants was reported by response at each assessment timepoint among participants with RA.
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0 and 15 minutes after injection on Days 0, 14, 28
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Percentage of Participants by Response to Device Satisfaction Questionnaire
Periodo de tiempo: Days 0, 14, 28
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Device satisfaction was assessed using twelve questions on a categorical 5-point Likert scale, ranging from "strongly agree" to "strongly disagree".
Question (Q) 1 (felt the autoinjection was easy to use), Q2 (felt comfortable while using the autoinjector), Q3 (felt the autoinjector was easy to hold), Q4 (able to tell when injection had completed), Q5 (felt he/she can inject properly with the autoinjector), Q6 (felt he/she had control over the injection process), Q7 (felt confident that he/she injected successfully), Q8 (felt it is easy to dispose of the autoinjector), Q9 (autoinjector would help to manage his/her injection schedule), Q10 (liked the look/feel of the autoinjector), Q11 (would recommend the autoinjector to someone else who needed to inject), Q12 (would continue having injections with the autoinjector).
The percentage of participants was reported by response at each assessment among participants with RA, CGs, and HCPs.
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Days 0, 14, 28
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Tender Joint Count (TJC) Among Participants With RA
Periodo de tiempo: Baseline (Day 0)
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Sixty-eight joints were assessed for tenderness among participants with RA.
The number of tender joints at Baseline was reported.
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Baseline (Day 0)
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Swollen Joint Count (SJC) Among Participants With RA
Periodo de tiempo: Baseline (Day 0)
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Sixty-six joints were assessed for swelling among participants with RA.
The number of swollen joints at Baseline was reported.
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Baseline (Day 0)
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
Periodo de tiempo: Days 0, 14, 28
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Ability to perform daily living activities was assessed across eight component sets including dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities.
Twenty questions were scored on a 4-point Likert scale from 0 meaning "without any difficulty" to 3 meaning "unable to do".
The overall score was computed as the sum of domain scores divided by the number of domains answered.
Therefore, the score range for HAQ-DI was the same as that of the individual questions, that is, from 0 to 3, where 0 indicates "least difficulty" and 3 indicates "extreme difficulty".
The mean change from baseline in HAQ-DI at each assessment was reported among participants with RA.
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Days 0, 14, 28
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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.
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)
21 de marzo de 2016
Finalización primaria (Actual)
29 de julio de 2016
Finalización del estudio (Actual)
29 de julio de 2016
Fechas de registro del estudio
Enviado por primera vez
11 de febrero de 2016
Primero enviado que cumplió con los criterios de control de calidad
11 de febrero de 2016
Publicado por primera vez (Estimar)
15 de febrero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
22 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
- WA29917
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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