跳至主要内容
临床试验/EUCTR2008-008554-23-SE
EUCTR2008-008554-23-SE进行中(未招募)不适用

eutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF

The Multiple Sclerosis Research Group, Department of Clinical Neuroscience0 个研究点目标入组 100 人开始时间: 2009年6月26日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100

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

  • 1.IFNß naïve MS patients with RRMS.
  • 2.18-60 years old.
  • 3.Patients who have agreed to initiate treatment with RNF
  • 4.Patients who have given signed consent to participate in the study.
  • 5.Women shall not be pregnant and shall not have the intention of becoming pregnant during the study.
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Patients with a previous treatment history of IFNß or IFN?.
  • 2.Patients with a positive NAb test before initiation of RNF.
  • 3.Patients treated with glatiramer acetate, IVIG or natalizumab within the previous 3 months.
  • 4.Patients treated with immunosuppressive treatments such as mitoxantrone, alemtuzumab or azathioprine during the previous 6 months.
  • 5.Patients with relevant non-MS condition potentially complicating IFNß treatment.
  • 6.Contraindication for interferon beta treatment as per SPC.
  • 7.Women that becomes pregnant.

研究者

发起方
The Multiple Sclerosis Research Group, Department of Clinical Neuroscience

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