- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02997605
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients (STAR)
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.
Обзор исследования
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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Bordeaux, Франция
- Bordeaux University Hospital
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Brest, Франция
- Brest University Hospital
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Cahors, Франция
- Jean Rougier Hospital
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Clermont-Ferrand, Франция
- Clermont-ferrand hospital
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Le Kremlin-Bicêtre, Франция
- Bicêtre Hospital
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Lille, Франция
- Lille Hospital
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Limoges, Франция
- Limoges hospital
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Montpellier, Франция
- Montpellier Hospital
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Nice, Франция
- Pasteur Hospital
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Orléans, Франция
- Orléans Hospital
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Paris, Франция
- La Pitié-Salpétrière
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Paris, Франция
- Cochin Hospital
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Paris, Франция
- Bichat hospital
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Pierre-Bénite, Франция
- Lyon Sud Hopsital
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Saint-Étienne, Франция
- Saint-Etienne Hospital
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Strasbourg, Франция
- Strasbourg Hospital
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Toujouse, Франция, 31059
- Hospital Pierre-Paul Riquet
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Patients ≥ 18 years old.
- Fulfilling the 2010 American College of Rheumatology (ACR)/EULAR criteria for RA.
- Treated with a stable dose of Synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARD) or Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) for at least 3 months.
- Who have been treated with prednisone or prednisolone for at least 6 months.
- With a stable dose of prednisone or prednisolone of 5mg/day for at least 3 months.
- With a DAS28 ≤3.2 for at least 3 months.
- Patients with health insurance
- Patients who have signed a written informed consent form.
Exclusion Criteria:
- Any chronic condition that would need long term corticoid use (e.g. chronic lung diseases).
- Evidence of a flare within the last 3 months.
- Evidence of an allergy or intolerance to hydrocortisone or prednisone.
- Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
- GC joint injections within the last 3 months or scheduled in the next 3 months.
- Any GC intake expected more than >5mg/day within the next 12 months.
- Association with sultopride and with live vaccines
- Significant trauma or major surgery within the 3 months prior to the baseline visit.
- Scheduled surgery in the next 12 months.
- Fibromyalgia.
- Foreseeable poor compliance with the strategy.
- Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
- Alcohol and/or drug misuse as determined by the investigator.
- Pregnancy or breastfeeding.
- Patient is not willing to sign the informed consent.
- Juridical Protection
- DAS28>3.2 after one month of a stable dose of prednisone 5 mg/day.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Glucocorticoid (GC) tapering
"GC tapering group": patients will be asked to taper prednisone taken every morning at 8.00 AM by decreasing the daily dose by 1 mg every month as soon as they are in remission or Low Disease Activity (LDA).
In addition they will receive a placebo of 20 mg/day of hydrocortisone (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg/day (at 8.00 AM) of hydrocortisone placebo for 3 months before discontinuing the hydrocortisone placebo.
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After inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: "GC tapering group" / Group 2: "Hydrocortisone replacement group". After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone.
Другие имена:
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Активный компаратор: Hydrocortisone replacer
"Hydrocortisone replacer group": patients will replace prednisone with 20 mg of hydrocortisone on a daily basis (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg daily (at 8.00 AM) for 3 months then stop as soon as they are in remission or LDA, as well as a prednisone placebo (at 8.00 AM) with a schedule to taper the prednisone placebo by 1mg/day every month until discontinuation.
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After inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: "GC tapering group" / Group 2: "Hydrocortisone replacement group". After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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proportion of patients who could withdraw from prednisone and hydrocortisone at one year
Временное ограничение: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
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To compare a prednisone tapering strategy to a hydrocortisone replacement strategy on the success rate of prednisone and hydrocortisone withdrawal at one year in Rheumatoid Arthritis patients in low disease activity or remission.
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one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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proportion of patients who could withdraw from prednisone
Временное ограничение: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
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To compare the proportion of patients who could withdraw from prednisone whatever the additional hydrocortisone associated treatment.
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one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
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proportion of patients with acute adrenal insufficiency
Временное ограничение: one year
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To compare the proportion of patients with acute adrenal insufficiency at one year between the two groups.
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one year
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proportion of patients with biological adrenal insufficiency
Временное ограничение: one year
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To compare the proportion of patients with biological adrenal insufficiency at one year between the two groups.
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one year
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proportion of patients needing extra prednisone to control flares
Временное ограничение: one year
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To compare the proportion of patients needing extra prednisone to control flares
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one year
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proportion of patients who have at least one flare confirmed by the investigator during the protocol.
Временное ограничение: one year
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To compare the proportion of patients who have at least one flare confirmed by the investigator during the protocol.
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one year
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area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)
Временное ограничение: one year
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To compare the area under the curve of the means of the FLARE (Flare Assessment in Rheumatoid Arthritis) at one year with a self-assessment questionnaire.
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one year
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proportion of patients in DAS28 remission and in DAS28 low disease activity
Временное ограничение: 7 and 12 months
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To compare the proportion of patients in DAS28 remission and in DAS28 low disease activity at 7 and 12 months between the groups.
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7 and 12 months
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medians of Health Assessment Questionnaire (HAQ)
Временное ограничение: 4, 7 months and 1 year
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To compare the medians of HAQ at 4, 7 months and one year between the groups.
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4, 7 months and 1 year
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medians of Rheumatoid Arthritis Impact of Disease (RAID)
Временное ограничение: 4, 7 months and 1 year
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To compare the medians of RAID at 4, 7 months and one year between the groups.
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4, 7 months and 1 year
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medians of EuroQol 5-dimensional Descriptive system (EQ-5D)
Временное ограничение: 4, 7 months and 1 year
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To compare the medians of EQ-5D at 4, 7 months and one year between the groups.
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4, 7 months and 1 year
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medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)
Временное ограничение: 4, 7 months and 1 year
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To compare the medians of FACIT-F at 4, 7 months and one year between the groups.
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4, 7 months and 1 year
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proportion of patients with Serious Adverse events
Временное ограничение: 1 year
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To compare the proportion of patients with Serious Adverse events at one year between the groups.
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1 year
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Adeline RUYSSEN-WITRAND, MD, PhD, University Hospital of Toulouse, Rheumatology Center
- Учебный стул: Arnaud CONSTANTIN, MD, PhD, University Hospital of Toulouse, Rheumatology Center
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
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
- Противовоспалительные агенты
- Противоопухолевые агенты
- Гормоны
- Гормоны, заменители гормонов и антагонисты гормонов
- Противоопухолевые агенты, гормональные
- Преднизолон
- Гидрокортизон
- Глюкокортикоиды
Другие идентификационные номера исследования
- RC31/15/7824
- PHRC (2001/1939)
- 2016-001618-18 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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