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临床试验/NL-OMON56344
NL-OMON56344暂停不适用

The safety and cost-effectiveness of discontinuing disease-modifying therapies in stable relapsing-onset multiple sclerosis (DOT-MS): a randomized rater-blinded multicenter trial. - Discontinuation of disease modifying therapy in multiple sclerosis (DOT-MS)

Vrije Universiteit Medisch Centrum0 个研究点目标入组 130 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
130

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Patients who are treated with one of the first-line treatments (any of the
  • interferons, glatiramer acetate, dimethylfumarate, teriflunomide) and who had a
  • complete absence of inflammatory activity (no relapses, no new-T2 lesions and
  • no contrast-enhancing lesions on MRI) for 5 consecutive years under first-line
  • treatment will be eligible for inclusion. In case the last available MRI-scan
  • was conducted 10 or more years ago, no more than 3 new T2-lesions in these 10
  • years are accepted.

排除标准

  • - Clinical or radiological inflammatory disease activity in the 5 years prior
  • to the study.
  • - A switch between first-line disease modifying therapy over two years prior to
  • inclusion, in case the switch has been due to in effectivity of the first DMT.
  • In case the switch has been due to side-effects or by a personal preference of
  • the patient (such as the wish to switch to oral therapies), this is not
  • considered as an exclusion criterium.
  • 3. Women who want to discontinue medication because of a pregnancy wish and
  • women who are pregnant or expect to become pregnant during the study period
  • 4. Patients that have previously used interferon-beta and have been tested
  • positive for neutralizing antibodies (NAbs).

研究者

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