NCT00458861终止2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy
研究概览
简要总结
This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
- •Methotrexate (10 mg/week to 25 mg/week) > 3 months prior to Day 0 (stable dose > 4 weeks prior to Day 0)
- •Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy
排除标准
- •Medical History
- •Serious local infection or systemic infection within 3 months of Day 0
- •History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
- •Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
- •Laboratory Tests
- •Clinically significant lab tests at screening; or
- •Positive for hepatitis C antibody or hepatitis 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 in RA participants who have had an inadequate response to anti-TNF therapy
时间窗: 26 weeks
次要结局
- Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.(26 weeks)
- Assess the safety and tolerability of BG9924 in this participant population.(26 weeks)
研究者
研究点 (2)
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