EUCTR2011-006070-73-DE进行中（未招募）不适用
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 - Oskira ABPM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female patients aged 18 or over diagnosed with Rheumatoid Arthritis after the age of 16
- •2. Active Rheumatoid Arthritis
- •3. Currently taking one of the following DMARD treatments: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
- •4.Patients with essential hypertension may be included provided that their BP is controlled (<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 117
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1. Females who are pregnant or breast feeding
- •2. Certain inflammatory conditions (other than RA), connective tissue diseases or chronic pain disorders
- •3. History of liver problems that have required previous investigations
- •4. Evidence of TB infection
- •5. Conditions that preclude or render difficult the 24-hour ABPM technique.
- •6. Known secondary causes of hypertension.
- •7. Evidence of recent significant CV disease.
- •8. Severely impaired renal function.
- •9. Evidence of recent or active infection.
- •10. Absolute neutrophil count (ANC) <1500/mm3 or 1.5 x 109/L.
- •11. Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study
研究者
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