NL-OMON47117已完成4 期
RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Rheumatoid arthritis: either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion.
- •- RTX retreatment: at least once RTX in the last 18 months for RA in a dose of 1 × 1000 mg, 2 × 1000 mg or 2 × 500 mg and no other biologicals received after last RTX dose. Patients treated with innovator RTX (MabThera) as well as registered biosimilars will be included.
- •- At least 6 months of stable, low disease activity after the last RTX infusion (operationalized by either DAS28-CRP<2.9 (DAS28-BSE <3.2) or judgement of low disease activity by a rheumatologist) AND a current DAS28-CRP *3.5 (DAS28-BSE*3.8).
- •- Patient informed consent, *18 years old and mentally competent
- •- Ability to measure the outcome of the study in this patient (e.g. life expectancy * 6 months, no planned relocation out of reach of study centre)
- •- Ability to read and communicate well in Dutch
排除标准
- •- Patients with known (non-)response to ultra-low dose RTX (below 1 × 1000 mg)
- •- Current corticosteroid dosing above 10 mg per day prednisolone equivalent
研究者
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