(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.
详细描述
(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Male or female aged 18 and over
- •Active rheumatoid arthritis (RA) diagnosed after the age of 16
- •6 or more swollen joints and 6 or more tender/painful joints from certain joints in the hands, wrists, arms and knees
- •At least one of: positive result for rheumatoid factor test, either in the past or currently (blood test); x-ray showing bone erosion within the last 12 months; presence of certain antibodies in the blood (blood test)
- •Currently taking methotrexate for at least 4 months (and on a stable dose for at least 6 weeks)
排除标准
- •Females who are pregnant or breast feeding
- •Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders.
- •Previously taken, but not responded to, certain biological treatments for rheumatoid arthritis
- •High blood pressure that is not controlled by medication
- •Low levels of neutrophils in the blood (blood test).
研究组 & 干预措施
Dosing A regimen
Oral treatment
干预措施: Fostamatinib (Drug)
Dosing B regimen
Oral treatment
干预措施: Fostamatinib (Drug)
Dosing C regimen
Oral treatment
干预措施: Fostamatinib (Drug)
Dosign D regimen
Oral treatment
干预措施: Fostamatinib (Drug)
Dosing E regimen
Oral treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo
时间窗: 12 weeks
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
次要结局
- Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo(1 week)
- Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo(12 weeks)
- Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo(12 weeks)
- Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo(12 weeks)
- ACRn - Comparison Between Fostamatinib and Placebo at Week 12(Baseline and 12 weeks)
- Proportion of Patients With DAS28-CRP EULAR Response at Week 12, Comparison Between Fostamatinib and Placebo(12 weeks)
- Proportion of Patients With HAQ-DI Response at Week 12, Comparison Between Fostamatinib and Placebo(12 weeks)
- SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 12(Baseline and 12 weeks)
- SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 12(Baseline and 12 weeks)