Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
22 января 2019 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
91
Фаза
- Фаза 4
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Arizona
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Mesa, Arizona, Соединенные Штаты, 85202
- Arizona Arthritis and Rheuma
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California
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Los Alamitos, California, Соединенные Штаты, 90720
- Valerius Medical Group & Research Ctr of Greater Long Beach
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Santa Maria, California, Соединенные Штаты, 93454
- Pacific Arthritis Ctr Med Grp
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Kentucky
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Lexington, Kentucky, Соединенные Штаты, 40515
- Bluegrass Comm Research, Inc.
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Oklahoma
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Tulsa, Oklahoma, Соединенные Штаты, 74104
- Oklahoma Center For Arthritis Therapy & Research
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Pennsylvania
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Duncansville, Pennsylvania, Соединенные Штаты, 16635
- Altoona Center for Clinical Research
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Wexford, Pennsylvania, Соединенные Штаты, 15090
- Advanced Rheumatology & Arthritis Research Center
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Texas
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Dallas, Texas, Соединенные Штаты, 75231
- Metroplex Clinical Research
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Возможности устройства
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
Другие имена:
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Экспериментальный: 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.
|
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.
Другие имена:
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Экспериментальный: 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.
|
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.
Другие имена:
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Другой: 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.
Другие имена:
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Другой: 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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
21 марта 2016 г.
Первичное завершение (Действительный)
29 июля 2016 г.
Завершение исследования (Действительный)
29 июля 2016 г.
Даты регистрации исследования
Первый отправленный
11 февраля 2016 г.
Впервые представлено, что соответствует критериям контроля качества
11 февраля 2016 г.
Первый опубликованный (Оценивать)
15 февраля 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
19 апреля 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
22 января 2019 г.
Последняя проверка
1 января 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- WA29917
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования AI-1000 G2
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ReFlow Medical, Inc.ClinLogix. LLCАктивный, не рекрутирующийЗаболевание периферических артерийНовая Зеландия, Германия, Швейцария
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Restor3DПрекращено
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Restor3DПрекращено
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Mayo ClinicЗавершенныйСердечно-сосудистые заболеванияСоединенные Штаты
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Yale UniversityЗавершенный
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Cedars-Sinai Medical CenterNational Cancer Institute (NCI)РекрутингЖелудочно-кишечные новообразования | Рак желудка | Рак тонкой кишки | Рак прямой кишки | Нейроэндокринная опухоль | Рак желчных протоков | Рак толстой кишки | Рак поджелудочной железы | Анальный рак | Рак печени | Рак желчевыводящих путей | Перитонеальный рак | Карциноидная опухоль | Рак желчного пузыря | Раковая боль | Карциноидная опухоль тонкой кишки и другие заболеванияСоединенные Штаты
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NHS Greater Glasgow and ClydeLenus Health; University of Glasgow Robertson Centre for Bio StatisticsРекрутинг
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Institute of Psychology, Chinese Academy of SciencesЗавершенныйДепрессия | Беспокойство | Диалоговый бот с искусственным интеллектом на базе LLMКитай
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Cedars-Sinai Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)ЗавершенныйХроническая боль в поясницеСоединенные Штаты
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Children's Hospital Los AngelesLumeum Inc.ЗавершенныйБеспокойство | Образовательные проблемыСоединенные Штаты