NCT00851240已完成1 期
A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Rheumatoid Arthritis - a Double-blind Randomized Placebo-controlled Sequential Group Trial
Biotie Therapies Corp.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence and intensity of adverse events
研究概览
简要总结
Patients with adult-onset rheumatoid arthritis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult-onset rheumatoid arthritis
排除标准
- 未提供
研究组 & 干预措施
BTT1023
Experimental
干预措施: BTT-1023 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and intensity of adverse events
时间窗: 17 wk
次要结局
- Disease activity(17 wk)
- Serum concentrations of the verum(17 wk)
研究者
研究点 (1)
Loading locations...
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