NCT01038674已完成1 期
A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis
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
- 16
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects 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
- Double (Participant, Investigator)
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
- •Informed consent obtained before any trial-related activities
- •A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
- •Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
- •Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
- •Male subjects and female subjects of non-child bearing potential
排除标准
- •Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
- •Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
- •History of or current inflammatory joint disease other than rheumatoid arthritis
- •Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
- •Past or current malignancy (as judged by the investigator)
- •Clinically significant cardiac or cardiovascular disease
- •Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis
- •Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations
- •Breast-feeding women
研究组 & 干预措施
Anti-IL-20
Experimental
干预措施: anti-IL-20 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: 0 - 21 weeks after dosing
次要结局
- Change in ACR20, ACR50 and ACR70(0-21 hours after dosing)
- Maximum observed serum concentration (Cmax)(6 - 10 weeks after dosing)
- Terminal serum half-life(0 - 21 weeks after dosing)
研究者
研究点 (1)
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