Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis
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: Rituximab.
- Кому может быть актуально
- Состояния в реестре: Rheumatoid Arthritis. Базовые параметры: от 18 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial
Обзор
The goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis. The main questions it aims to answer are: * What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact? * What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy? Participants will be randomized to one of two study arms: * Tapering based on disease-activity guided dose reduction (experimental arm) * Tapering based on interval prolongation (active comparator arm)
Вмешательства
- Препарат Rituximab
IV rituximab
Первичные конечные точки
- Comparison of disease impact in both study arms, measured using the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire [Срок оценки: Over 2 years (104 weeks)]
Вторичные конечные точки (11)
- Comparison of disease activity in both study arms, measured using the Disease Activity Score in 28 joints - C-reactive protein (DAS28-CRP) [Срок оценки: Over 2 years (104 weeks)]
- Comparison of disease activity in both study arms, measured using the Simplified Disease Activity Index (SDAI) [Срок оценки: Over 2 years (104 weeks)]
- Comparison of cumulative dose of rituximab in both study arms [Срок оценки: Over 2 years (104 weeks)]
- Comparison of cumulative dose of glucocorticoids in both study arms [Срок оценки: Over 2 years (104 weeks)]
- Proportion of patients in both study arms achieving a good or moderate European League Against Rheumatism (EULAR) treatment response after administration of rituximab, over a period of 2 years (104 weeks) [Срок оценки: Over 2 years (104 weeks)]
- Comparison of loss of disease control in both study arms [Срок оценки: Over 2 years (104 weeks)]
- Comparison of rituximab drug retention rate in both study arms [Срок оценки: Over 2 years (104 weeks)]
- Proportion of patients tapering rituximab below 1000 mg in the experimental arm [Срок оценки: Over 2 years (104 weeks)]
- Mean/median interval between rituximab administrations in the active comparator group [Срок оценки: Over 2 years (104 weeks)]
- Comparison of serious adverse events/reactions rates in both study arms. [Срок оценки: Over 2 years (104 weeks)]
- Comparison of serious infections rate in both study arms. [Срок оценки: Over 2 years (104 weeks)]
Критерии участия
Критерии включения
- Able and willing to give written informed consent and participate in the study before any study procedure.
- Age ≥ 18 years.
- Understanding and able to write in Dutch or French.
- Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for rheumatoid arthritis.
- Previous response to rituximab, defined as a minimum of one successful rituximab cycle (= a moderate/good EULAR response 16 weeks after the first administration of rituximab).
- Current treatment with rituximab.
- Need for a subsequent rituximab cycle according to the Belgian reimbursement criteria for the use of rituximab in rheumatoid arthritis (DAS28 score ≥3.2).
- Stable dose of methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (DMARDs) 4 weeks prior to baseline.
Критерии исключения
- Current treatment with another biological DMARD than rituximab.
- Current treatment with a targeted synthetic DMARD.
- Pregnancy or pregnancy wish.
- Presence of an absolute contraindication to treatment with rituximab, according to the label of rituximab and according to medical judgement.
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Бельгия · 7 центров
- ZNA Jan Palfijn — Merksem
- Cliniques Universitaires Saint-Luc Bruxelles — Brussels
- Reumacentrum Genk — Genk
- ReumaClinic Genk — Genk
- OLV Aalst — Aalst
- RZ Heilig Hart — Leuven
- University Hospitals Leuven (UZ Leuven) — Leuven
Публикации
- De Meyst E, Bertrand D, Joly J, Doumen M, Marchal A, Thelissen M, Neerinckx B, Westhovens R, Verschueren P. Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: study protocol for a multicentre randomised controlled superiority trial focusing on long-term disease impact (R PMID 39407334
Идентификаторы
NCT: NCT06003283 · S67309