NCT01711814已完成2 期
A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 611
- 试验地点
- 51
- 主要终点
- Safety assessed by recording of adverse events and clinical laboratory evaluations
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study.
详细描述
This study is comprised of a 104 week treatment period beginning on Day 1 of study drug administration and a 30-day follow-up period or permanent termination of clinical development of the product, whichever is earlier.
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
- •Subject completed the week 12 visit in one of the Phase 2, ASP015K Rheumatoid Arthritis studies within the previous 14 days.
- •Male and Female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation
排除标准
- •Subject has any condition considered by the Principal Investigator or Medical Monitor to preclude adequate evaluation of drug safety
- •Subject is scheduled to receive any investigational drug other than ASP015K during the course of the study
- •Subject is scheduled to receive a prohibited medication
- •Subject has a planned major surgery
- •Subject discontinued study drug due to meeting study drug discontinuation criteria prior to completion of the Week 12 visit in the preceding study or fulfills study drug discontinuation criteria at the final study visit of the preceding study
- •Subject has out of range laboratory values within 14 days of the Day 1 study dosing
- •Absolute lymphocyte count (ALC) < 500/mm3
- •Creatine Phosphokinase (CPK) > 1.5 x upper limit of normal unless the level has been stable for at least 2 consecutive blood draws (at least 7 days apart), and subject does not have symptoms of muscle aching, weakness, or severe unusual muscle cramps
研究组 & 干预措施
ASP015K
Experimental
Experimental
干预措施: peficitinib (Drug)
结局指标
主要结局
Safety assessed by recording of adverse events and clinical laboratory evaluations
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (51)
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