NCT01563978已完成2 期
OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Change From Baseline in 24-hour Mean Ambulatory SBP
研究概览
简要总结
The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (DMARD).
The study will last for 57 days.
详细描述
OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis
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 and female patients aged 18 or over diagnosed with rheumatoid arthritis after the age of 16
- •Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or C-reactive protein ≥10 mg/L.
- •Currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
- •Patients without essential hypertension or with essential hypertension if their blood pressure is controlled (<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.
排除标准
- •Females who are pregnant or breastfeeding.
- •Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
- •History of liver problems that have required previous investigations
- •Evidence of tuberculosis infection
- •Conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.
研究组 & 干预措施
Dosing Regimen A
Experimental
Oral treatment
干预措施: fostamatinib (Drug)
Dosing Regimen B
Placebo Comparator
Oral treatment
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in 24-hour Mean Ambulatory SBP
时间窗: 4 weeks
ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
次要结局
- Change From Baseline in 24-hour Mean Ambulatory DBP(4 weeks)
- Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring(4 weeks)
- Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring(4 weeks)
- Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring(4 weeks)
- Mean Change From Baseline in Morning Pre-dose Home SBP and DBP(4 weeks)
- Mean Change From Baseline in Evening Post-dose Home SBP and DBP(4 weeks)
- Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP(Day 29 to Day 36)
- DAS28-CRP Improvement(4 weeks)
- Mean Change From Baseline in Clinic SBP and DBP(4 weeks)
研究者
研究点 (1)
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