NCT00639834已完成1 期
A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
Bristol-Myers Squibb46 个研究点 分布在 5 个国家目标入组 26 人开始时间: 2008年2月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 46
- 主要终点
- incidence and severity of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed.
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
- •Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)
- •Must have active RA
- •Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
- •All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration
排除标准
- •Both Rheumatoid factor and anti-CCP negative
- •Prior treatment with any B-cell depleting therapy
- •Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit
- •History of or current inflammatory joint disease other than RA
- •Neuropathies or neurovasculopathies that might interfere with pain evaluation
- •Complications of RA or other disease
- •Any other autoimmune disease other than RA
- •Acute or chronic infection
- •Clinically significant disease requiring
结局指标
主要结局
incidence and severity of treatment-emergent adverse events
时间窗: all adverse events will be followed to resolution
次要结局
未报告次要终点
研究者
研究点 (46)
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