NCT01640054终止2 期
(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
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
- AstraZeneca
- 入组人数
- 115
- 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 in Asia with rheumatoid arthritis (RA).
详细描述
(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
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
- •Provision of informed consent prior to any study-specific procedures.
- •Patients who have successfully completed study D4300C00008 and whose disease is adequately controlled, in the opinion of the Investigator.
排除标准
- •Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the patient's disease is not adequately controlled on current treatment.
- •Development of any of the withdrawal criteria from study D4300C00008
- •Females who are pregnant or breast feeding
- •Any other clinically significant disease or disorder, which in the opinion of the Investigator might put the patient at risk due to participation in the study, or may influence the results of the study
研究组 & 干预措施
Dosing regimen
Experimental
Open label Oral treatment 100mg once daily
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 study termination (variable duration; maximum 52 weeks)
AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event
次要结局
- DAS28-CRP Score Over Time(Every 12 weeks for one year then every 24 weeks until study end)
- SF-36 Score Over Time(Every 12 weeks for one year then yearly until study end)
- Components of ACR Response Criteria Over Time(Every 12 weeks for one year then every 24 weeks until study end)
- HAQ-DI Score Over Time(Every 12 weeks for one year then every 24 weeks until study end)
研究者
研究点 (1)
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