An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)
研究概览
简要总结
This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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;
- •active rheumatoid arthritis;
- •receiving outpatient treatment;
- •an inadequate response, or intolerance, to >=1 anti-TNF agent.
排除标准
- •other rheumatic autoimmune disease or inflammatory joint disease;
- •concurrent treatment with any anti-TNF-alpha therapy;
- •joint or osseous surgery during 8 weeks prior to recruitment.
研究组 & 干预措施
1
干预措施: rituximab [MabThera/Rituxan] (Drug)
1
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)
时间窗: Week 24
DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour \[mm/hr\]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.
次要结局
- Percentage of Participants Achieving American College of Rheumatology (ACR) Response(Week 24)
- Change From Baseline in HAQ-DI Score(Week 24)
- Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category(Week 24)