NCT01181050已完成2 期
A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Change in DAS28-CRP After 12 Weeks of Treatment
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to 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
- •A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product
- •Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
- •Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing
- •Ability to be examined by Magnetic Resonance Imaging (MRI)
- •Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs
排除标准
- •Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
- •Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start
- •Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m^2
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects received a single dose of placebo
干预措施: placebo (Drug)
4.0 mg/kg
Experimental
Subjects received a single dose of 4 mg/kg NNC0142-0002
干预措施: NNC0142-0002 (Drug)
结局指标
主要结局
Change in DAS28-CRP After 12 Weeks of Treatment
时间窗: Week 0, Week 12
DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.
次要结局
- Change in DAS28-CRP After 6 Weeks of Treatment.(Week 0, Week 6)
- Change in DAS28-CRP After 24 Weeks of Treatment.(Week 0, Week 24)
研究者
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