Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Iguratimod, low-dose rituximab.
- Кому может быть актуально
- Состояния в реестре: Immune Thrombocytopenia (ITP). Базовые параметры: 18 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.
Подробное описание
Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. The small molecule compound iguratimod is widely used as a novel antirheumatic drug to treat several autoimmune diseases. According to studies involving ITP mice, iguratimod may represent a new approach for the prevention and treatment of anti-platelet antibody-mediated ITP by modulating T-cell differentiation.
A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+iguratimod and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment.Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and iguratimod in patients with steroid-resistant/relapsed ITP.
Вмешательства
- Препарат Iguratimod
oral iguratimod at 25mg twice daily for 26 weeks - Препарат low-dose rituximab
rituximab 100mg once weekly for 6 weeks
Первичные конечные точки
- overall response [Срок оценки: From the start of study treatment (Day 1) up to the end of Year 1]
Вторичные конечные точки (7)
- sustained response [Срок оценки: From the start of study treatment (Day 1) up to the end of Year 1]
- complete response [Срок оценки: From the start of study treatment (Day 1) up to the end of Year 1]
- time to response [Срок оценки: From the start of study treatment (Day 1) up to the end of Year 1]
- duration of response [Срок оценки: From the start of study treatment (Day 1) up to the end of Year 1]
- incidence of adverse events [Срок оценки: All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to CTCAE 5.0]
- Bleeding events [Срок оценки: From the start of study treatment (Day 1) up to the end of Year 1]
- Health-related quality of life (HRQoL) [Срок оценки: From the start of study treatment (Day 1) up to the end of Year 1]
Критерии участия
Критерии включения
- ITP confirmed by excluding other supervened causes of thrombocytopenia;
- Platelet count of less than 30×10\^9/L at enrollment;
- Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
Критерии исключения
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);
- Congestive heart failure;
- Severe arrhythmia;
- Nursing or pregnant women;
- Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria;
- Creatinine or serum bilirubin levels each 1•5 times or more than the normal range;
- Active or previous malignancy;
- Patients with other diseases were undergoing treatment with immunosuppressants;
- Patients with ITP had received rituximab;
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Peking University Insititute of Hematology — Пекин
Идентификаторы
NCT: NCT07057778 · Pku-IGU-ITP-03