NCT00134693已完成2 期
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 29
- 主要终点
- Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323
研究概览
简要总结
This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.
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
- Double (Participant, Investigator)
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
- •Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
- •Must have 3 or more swollen or 3 or more tender/painful joints at screening.
- •Must be on stable weekly methotrexate (2.5mg - 25mg) for at least eight weeks prior to screening.
排除标准
- •Must not be morbidly obese.
结局指标
主要结局
Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323
时间窗: Day 3 (at 72 hour)
CRP levels were compared between SB-681323 and placebo 72 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.
次要结局
- Number of participants with adverse events (AE) and serious adverse events (SAE)(Upto Day 3 (72 hours))
- Analysis of CRP levels 24 and 48 hours post-dose following SB-681323(Day 1 (at 24 hour) and Day 2 (at 48 hour))
- Change from Baseline in vital sign systolic blood pressure (SBP) and diastolic blood pressure (DBP)(Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour))
- Number of participants with clinical chemistry data outside the clinical concern range(Upto Day 3 (pre-dose, 24, 48 and 72 hours)
- Analysis of Interleukin (IL)-6 levels up to 72 hours post-dose following SB-681323(Upto Day 3 (at 1, 3, 24 and 72 hour))
- Number of participants with abnormal electrocardiogram (ECG) findings(Day 1 (pre-dose, 1 hour and 3 hour))
- Change from Baseline in vital sign heart rate(Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour))
- Number of participants with hematology data outside the clinical concern(Upto Day 3 (pre-dose, 24 and 72 hours))
- Number of participants with abnormal urinalysis dipstick results(Upto Day 3 (pre-dose, 24 and 72 hours))
- Whole blood messenger RNA (mRNA) levels of tumor necrosis factor alpha [TNF-α], IL-8, IL-1β and Cyclo-oxygenase-2 [COX-2] (and other genes implicated in the pathogenesis of RA or genes involved in the mode of action of the compounds administered)(Pre-dose, 45 minutes, 90 minutes and 3 hours on Day 1)
研究者
研究点 (29)
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