EUCTR2020-002507-19-NL进行中（未招募）1 期
Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Rheumatoid arthritis: either 2010 EULAR/ACR RA and/or 1987 ACR RA criteria and/or clinical diagnosis of the treating rheumatologist;
- •2. Patients using rituximab in ultra-low dose: either 200 mg or 500 mg as previous dose, given every 6 months, with or without concomitant methotrexate;
- •3. Having sufficient response to rituximab treatment, operationalized as a DAS28-CRP < 2.9 3-6 months after the last infusion and/or judgment of low disease activity by the treating rheumatologist;
- •4. =16 years old and mentally competent;
- •5. Ability to read and communicate well in Dutch.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous non-response to ultra-low dose rituximab (DAS28-CRP > 2.9);
- •2. Objection or contraindication to either of the treatment options;
研究者
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