NCT06003283招募中4 期
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 7
- 主要终点
- Comparison of disease impact in both study arms, measured using the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tapering of rituximab based on disease activity guided dose reduction
Experimental
Treatment with rituximab every 6 months (24 weeks) with dosing based on disease activity, measured by the DAS28-CRP.
DAS28-CRP ≤ 3.2: dose reduction according to the following sequence: 1 x 1000 mg IV (maximum), 1 x 500 mg IV, 1 x 200 mg IV (minimum).
DAS28-CRP > 3.2: administration of previously effective dose.
干预措施: Rituximab (Drug)
Tapering of rituximab based on interval prolongation
Active Comparator
Treatment with fixed dose of rituximab (1 x 1000 mg IV) if DAS28-CRP ≥ 3.2 AND interval of at least 6 months (24 weeks) since previous administration of rituximab.
干预措施: Rituximab (Drug)
结局指标
主要结局
Comparison of disease impact in both study arms, measured using the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire
时间窗: Over 2 years (104 weeks)
RAID questionnaire score range: 0 - 10, with higher scores indicating worse status.
次要结局
- Comparison of disease activity in both study arms, measured using the Disease Activity Score in 28 joints - C-reactive protein (DAS28-CRP)(Over 2 years (104 weeks))
- Mean/median interval between rituximab administrations in the active comparator group(Over 2 years (104 weeks))
- Comparison of cumulative dose of rituximab in both study arms(Over 2 years (104 weeks))
- Comparison of disease activity in both study arms, measured using the Simplified Disease Activity Index (SDAI)(Over 2 years (104 weeks))
- Comparison of loss of disease control in both study arms(Over 2 years (104 weeks))
- Comparison of cumulative dose of glucocorticoids in both study arms(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)(Over 2 years (104 weeks))
- Comparison of rituximab drug retention rate in both study arms(Over 2 years (104 weeks))
- Comparison of serious infections rate in both study arms.(Over 2 years (104 weeks))
- Proportion of patients tapering rituximab below 1000 mg in the experimental arm(Over 2 years (104 weeks))
- Comparison of serious adverse events/reactions rates in both study arms.(Over 2 years (104 weeks))
研究者
研究点 (7)
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