An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
6 июля 2016 г. обновлено: Hoffmann-La Roche
A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent
This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy.
Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy.
Data will be collected for 12 months.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Наблюдательный
Регистрация (Действительный)
90
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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Busan, Корея, Республика, 48108
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Daegu, Корея, Республика, 41931
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Daegu, Корея, Республика, 42472
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Daejeon, Корея, Республика, 302-799
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Gwangju, Корея, Республика, 61469
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Gyeonggi-do, Корея, Республика, 10380
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Jeju Special Self-Governing Province, Корея, Республика, 63241
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Jeollabuk-do, Корея, Республика, 561-712
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Seoul, Корея, Республика, 150-713
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Seoul, Корея, Республика, 130-702
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Seoul, Корея, Республика, 05030
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Seoul, Корея, Республика, 06273
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Seoul, Корея, Республика, 134-722
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Suwon, Корея, Республика, 442-723
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Ulsan, Корея, Республика, 44033
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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
20 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Вероятностная выборка
Исследуемая популяция
Adult participants with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy.
Описание
Inclusion Criteria:
- Adult participants, >/=20 years of age
- Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy
Exclusion Criteria:
- Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
- Participants who have not signed the informed consent form
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
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Rituximab
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
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Rituximab as per physician's discretion.
Другие имена:
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Other anti-TNF agent
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.
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Adalimumab as per physician's discretion.
Etanercept as per physician's discretion.
Infliximab as per physician's discretion.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
Временное ограничение: Baseline and Month 6
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 6
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Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
Временное ограничение: Baseline and Month 6
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 6
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Efficacy: Mean Change From Baseline in DAS28 at Month 12
Временное ограничение: Baseline and Month 12
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 12
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Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Временное ограничение: Baseline, Month 6 and 12
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TJC is a clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
The number of tender joints were scored as tender=1 and not tender=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of tender joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
Временное ограничение: Baseline, Month 6 and 12
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TJC is a clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
The number of tender joints were scored as tender=1 and not tender=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of tender joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Временное ограничение: Baseline, Month 6 and 12
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SJC is a clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
The number of swollen joints were scored as swollen=1 and not swollen=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
Временное ограничение: Baseline, Month 6 and 12
|
SJC is a clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
The number of swollen joints were scored as swollen=1 and not swollen=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
Временное ограничение: Baseline, Month 6 and 12
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ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
Временное ограничение: Baseline, Month 6 and 12
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ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
Временное ограничение: Baseline, Month 6 and 12
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CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
Временное ограничение: Baseline, Month 6 and 12
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CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population
Временное ограничение: Month 6
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The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
Each domain has at least two component questions.
There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).
The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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Month 6
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Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)
Временное ограничение: Month 6
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The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
Each domain has at least two component questions.
There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).
The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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Month 6
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Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
Временное ограничение: Baseline up to Month 12
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties.
A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
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Baseline up to Month 12
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
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
1 ноября 2011 г.
Первичное завершение (Действительный)
1 декабря 2014 г.
Завершение исследования (Действительный)
1 декабря 2014 г.
Даты регистрации исследования
Первый отправленный
11 апреля 2012 г.
Впервые представлено, что соответствует критериям контроля качества
3 мая 2012 г.
Первый опубликованный (Оценивать)
7 мая 2012 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
22 августа 2016 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 июля 2016 г.
Последняя проверка
1 марта 2016 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания иммунной системы
- Аутоиммунные заболевания
- Заболевания суставов
- Заболевания опорно-двигательного аппарата
- Ревматические заболевания
- Заболевания соединительной ткани
- Артрит
- Артрит, Ревматоидный
- Физиологические эффекты лекарств
- Агенты периферической нервной системы
- Анальгетики
- Агенты сенсорной системы
- Противовоспалительные средства, нестероидные
- Анальгетики, ненаркотические
- Противовоспалительные агенты
- Противоревматические агенты
- Противоопухолевые агенты
- Иммунодепрессанты
- Иммунологические факторы
- Желудочно-кишечные агенты
- Противоопухолевые агенты, иммунологические
- Дерматологические агенты
- Этанерцепт
- Адалимумаб
- Ритуксимаб
- Инфликсимаб
Другие идентификационные номера исследования
- ML27923
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. .