EUCTR2017-004861-29-NO进行中（未招募）1 期
BackToBasic: The effect of Infliximab in patients with chronic low back pain and Modic changes. A randomized, double blind, placebo-controlled, multicenter trial
FOU, Nevroklinikken, Oslo University Hospital -Ullevål0 个研究点目标入组 126 人开始时间: 2018年4月10日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
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
- •-Age between 18 and 65 years
- •-Low back pain of > 6 months duration with a Numerical Rating Scale (NRS) pain intensity score of 5
- •-Modic Changes type I in the lumbar vertebral body
- •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 126
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Any contraindication or increased risk of side-effects from Infliximab (such as ongoing infection, recent live vaccination or planned live vaccination, immunocompromised, ongoing glucocorticoid treatment or allergy against any products of the medication)
- •- Current pregnancy or lactation
- •- For women of childbearing potential; inadequate birth control, pregnancy, and/or breastfeeding.
- •- Not able to understand written and spoken Norwegian
- •- Not able to complete treatment or follow-ups in the study (i.e. contraindications for MRI, severe psychiatric disease, drug abuse or plans of moving)
研究者
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