NCT01565408已完成1 期
Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with 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
- •A diagnosis of RA, meeting the 2010 ACR-EULAR (American College of Rheumatology-European League Against Rheumatism) or the 1987 ACR classification criteria, made at least 4 months prior to trial drug administration
- •Active RA, characterised by a DAS28-CRP equal to or above 4.5 and at least 5 tender and 5 swollen joints
- •Methotrexate (MTX) treatment for at least 16 weeks (dose equal to or above 7.5 mg/week and equal to or below 25 mg/week) at a stable dose for at least 6 weeks prior to dosing
- •Female subjects not pregnant and not nursing
排除标准
- •Subjects with chronic inflammatory autoimmune disease other than RA
- •Any active or ongoing chronic infectious disease requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
- •Body mass index (BMI) below 18.0 or above 35.0 kg/m^2
研究组 & 干预措施
NNC0114-0006
Experimental
干预措施: NNC0114-0006 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: From first administration of trial product (week 1) and up until week 27
次要结局
- Change in serum levels of total IL-21 from first administration of trial product(Week 1, week 27)
- Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP)(From week 1 to week 9 (8 weeks after initiation of treatment))
研究者
研究点 (1)
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