An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- ACR20
研究概览
简要总结
To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself.
- •At Visit2(0 week), Subjects must have completed the previous study (TS152-3000-JA or TS152-3001-JA) ,and must have completed all evaluations required at the follow-up visit.
排除标准
- •Subjects who had serious adverse drug reactions in the previous study.
- •At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events.
研究组 & 干预措施
TS-152 30mg SC
TS-152 30mg subcutaneously (SC) every 4 weeks
干预措施: TS-152 (Drug)
TS-152 80mg SC
TS-152 80mg subcutaneously (SC) every 4 weeks
干预措施: TS-152 (Drug)
结局指标
主要结局
ACR20
时间窗: through study completion, an average of 3 year
Percentage of Subjects who meet the American College of Rheumatology 20% (ACR20) Criteria from baseline of previous study (TS152-3001-JA or TS152-3001-JA).
Incidence of adverse events
时间窗: through study completion, an average of 3 year
To evaluate the Long-term safety of TS-152 in RA patients by incidence of adverse events which include vital signs, and clinical laboratory parameters.
次要结局
未报告次要终点