NCT00523328终止2 期
An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects With Rheumatoid Arthritis Who Previously Participated in Study 104RA203
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.
研究概览
简要总结
This study is to observe the long-term treatment of BG9924
详细描述
Extension study for 104RA203 (NCT 00458861)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a participant from Study 104RA203 (NCT 00458861)
排除标准
- •Participants with a significant change in medical history from their previous BG9924 Study 104RA203 (NCT 00458861).
- •Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
- •Male and female participants of child-bearing potential not willing to practice effective birth control for the duration of the study.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
BG9924
Experimental
dosage administered as per Biogen-idec protocol
干预措施: BG9924 (Drug)
结局指标
主要结局
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.
时间窗: The duration of this study is 18 months.
次要结局
未报告次要终点
研究者
研究点 (1)
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