EUCTR2010-019261-28-DE进行中（未招募）不适用
A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men and women (not pregnant and not nursing) of =18 and =75 years of age
- •Subjects with active RA characterised by a DAS28-CRP =4.5 and at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
- •Ability to be examined by MRI
- •Concomitant treatment with MTX (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing with trial product
- •Having failed no biologic therapies for RA and no more than two non-biologic DMARDs
- •(primary or secondary failures to therapy)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Chronic inflammatory autoimmune disease other than RA
- •Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation
- •Body mass index (BMI) =18.0 or =40.0 kg/m^2
研究者
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