An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Disease Activity Score Based on 28-Joint Count (DAS28)
研究概览
简要总结
This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). 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
- 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;
- •diagnosed RA for >=3 months prior to first administration of study medication;
- •inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
- •if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.
排除标准
- •other chronic inflammatory diseases;
- •use of parental corticosteroids within 4 weeks prior to screening;
- •severe heart failure, or severe, uncontrolled cardiac disease.
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
Disease Activity Score Based on 28-Joint Count (DAS28)
时间窗: Day 0 and Week 24
DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (\>)3.2 to 5.1 = moderate to high disease activity.
次要结局
- Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores(Day 0 and Week 24)
- Anti-cyclic Citrullinated Peptide (Anti-CCP)(Day 0 and Week 24)
- Erythrocyte Sedimentation Rate (ESR)(Day 0 and Week 24)
- C-Reactive Protein (CRP)(Day 0 and Week 24)
- Vascular Endothelial Growth Factor (VEGF)(Day 0 and Week 24)