An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Number of Participants Reporting Adverse Events (AEs)
研究概览
简要总结
In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is <50
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •adult patients >/= 18 years of age
- •rheumatoid arthritis DAS28 >/= 3.2
- •receiving treatment on an outpatient basis
- •experienced an inadequate response to previous or current treatment with methotrexate
排除标准
- •rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- •history of or current inflammatory joint disease other than RA
- •previous treatment with any cell-depleting therapies
研究组 & 干预措施
single arm
干预措施: rituximab [MabThera/Rituxan] (Drug)
single arm
干预措施: methotrexate (Drug)
single arm
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Number of Participants Reporting Adverse Events (AEs)
时间窗: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks
次要结局
- Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24(Baseline and Week 24)
- Change in Bone Density (in Participants Untreated With Bisphosphonates)(Screening and Week 84)
- Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24(Baseline and Week 24)