NCT00411424已完成1 期
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of ASK8007 in Comparison With Placebo in Patients With Active Rheumatoid Arthritis - a Randomized, Double Blind, Placebo-controlled, Combined Single Dose Escalation and Multiple Dose Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Safety and tolerability MD ASK8007
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of the new medication ASK8007, and to study whether it has a beneficial effect on joint inflammation 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
- •meet the American Rheumatism Association (ARA) 1987 revised criteria for the classification of RA (also referred to as the American College of Rheumatology [ACR] criteria);
- •being treated with an adequate dose (to the discretion of the local physicians) of either MTX or leflunomide (LEF)or sulfasalazine (SS2) for at least 4 months prior to baseline of which the last 6 weeks before baseline were at a stable dose;
- •have active poly-arthritis (i.e. active rheumatoid arthritis as defined in detail in the protocol)
排除标准
- •have been treated with any registered or non-registered investigational drug in the context of a clinical intervention study during the last 3 months before baseline;
- •have been treated with TNFα-blockers within a certain period of time (defined for each medication) before baseline;
- •have been treated with any DMARD other than MTX, LEF or SS2 during the last month before baseline;
- •documented evidence for the presence of clinically severe, unstable, or uncontrollable renal, hepatic, respiratory, hematological, genitourinary, cardiovascular, endocrine, neurological, psychiatric, or other medical illness which would, in the opinion of the investigator, put the patient at safety risk or mask measures of efficacy.
研究组 & 干预措施
1
Experimental
干预措施: ASK8007 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability MD ASK8007
时间窗: up to 10 weeks after last dose
次要结局
- DAS28+CD68(Day 43 compared to baseline)
研究者
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