(OSKIRA-3): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With Inadequate Response to a TNF-alpha Antagonist
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.
详细描述
Sub-study:
Full title: Optional Genetic Research
Date: 18 June 2010
Version: 1
Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA
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
- •Active rheumatoid arthritis (RA) diagnosed after the age of 16
- •Currently taking methotrexate
- •6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
- •At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
排除标准
- •Females who are pregnant or breast feeding
- •Poorly controlled hypertension
- •Liver disease or significant liver function test abnormalities
- •Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
- •Recent or significant cardiovascular disease
- •Significant active or recent infection including tuberculosis
- •Previous failure to respond to anakinra or previous treatment with biological agent (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
- •Severe renal impairment
- •Neutropenia
研究组 & 干预措施
Dosing Regimen A
Oral Treatment
干预措施: fostamatinib (Drug)
Dosing Regimen B
Oral Treatment
干预措施: fostamatinib (Drug)
Dosing Regimen C
Oral Treatment
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo
时间窗: 24 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 daily.
次要结局
- Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo(24 weeks)
- Proportion of Patients Achieving DAS28-CRP <=3.2 at Week 12, Comparison Between Fostamatinib and Placebo(12 weeks)
- Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo(24 weeks)
- Proportion of Patients With a HAQ-DI Response at Week 24 - Comparison Between Fostamatinib and Placebo(24 weeks)
- Change From Baseline to Week 24 in mTSS Score, Comparison Between Fostamatinib and Placebo(Baseline and 24 weeks)
- SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24(Baseline and 24 weeks)
- Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo(1 week)
- Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo(24 weeks)
- Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo(24 weeks)
- ACRn - Comparison Between Fostamatinib and Placebo at Week 24(Baseline and 24 weeks)
- SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24(Baseline and 24 weeks)