NCT00664716已完成2 期
Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 391
- 试验地点
- 9
- 主要终点
- Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy
研究概览
简要总结
Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosis of RA (functional class I - III)
- •Stable dose of MTX
- •Inadequate response to at least one conventional DMARD therapy
排除标准
- •Serious local infection or systemic infection
- •History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment
- •Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
- •Clinical significant lab tests at screening
- •Positive for Hep C or Hep B at screening
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy
时间窗: 3 months
次要结局
- Assess the safety and tolerability of BG9924 in this participant population(3 months)
研究者
研究点 (9)
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