NCT01282255已完成2 期
A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).
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
- •Czech Republic: Age between 18 - 65 years (both inclusive)
- •A diagnosis of RA made at least 3 months prior to trial start
- •Active RA
- •Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
- •Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
- •Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode
排除标准
- •Known or suspected allergy to trial product or related products
- •Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m^2
- •Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
研究组 & 干预措施
A
Experimental
干预措施: NNC109-0012 (Drug)
B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
时间窗: week 0, week 12
次要结局
- Terminal serum half-life (t½)(end of treatment period)
- Serum levels of NNC109-0012(end of treatment period)
研究者
研究点 (1)
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