NCT02371096Unknown1 期
Comparative Pharmacokinetic Trial of RGB-03 and MabThera
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 主要终点
- Area under the serum concentration versus time curve (AUC)
研究概览
简要总结
Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Rheumatoid Arthritis
- •Inadequate response or intolerance to other DMARDs and anti-TNFs
- •Treatment with Methotrexate
排除标准
- •Previous treatment with rituximab
- •Patients with systemic manifestations of rheumatoid arthritis
- •Patients seropositive for HIV, HCV, HBV
- •Female patients nursing
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
RGB-03
Experimental
干预措施: RGB-03 (Drug)
MabThera (rituximab)
Active Comparator
干预措施: MabThera (rituximab) (Drug)
结局指标
主要结局
Area under the serum concentration versus time curve (AUC)
时间窗: 0-24 weeks
次要结局
未报告次要终点
研究者
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