NCT01242514终止3 期
(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 1,917
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
研究概览
简要总结
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
- •Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).
排除标准
- •Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
- •Females who are pregnant or breast feeding
- •Poorly controlled hypertension
- •Significant liver function test abnormalities or physical symptoms of hepatotoxicity
- •Significant infection
- •Gastrointestinal intolerance
研究组 & 干预措施
A
Experimental
Oral treatment
干预措施: Fostamatinib (Drug)
B
Experimental
Oral treatment
干预措施: Fostamatinib (Drug)
C
Experimental
Oral treatment
干预措施: Fostamatinib (Drug)
结局指标
主要结局
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
时间窗: Entry in extension to end of study (variable duration; maximum 109 weeks)
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
次要结局
- Mean DAS28-CRP Score(Weeks 0, 12, 24, 36 and 52)
- Mean mTSS Score(Weeks 0 and 52)
- Mean HAQ-DI Score(Weeks 0, 12, 24, 36 and 52)
研究者
研究点 (1)
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