EUCTR2020-005752-38-DE进行中（未招募）1 期
An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC)
ovartis Pharma GmbH0 个研究点目标入组 60 人开始时间: 2021年1月19日最近更新:
适应症
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
- 60
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. Signed informed consent must be obtained prior to participation in the study.
- •2. One of the following MS treatments as part of clinical routine:
- •a. Cohort 1: Siponimod treatment according to EU SmPC without interrupting daily dosing for the purpose of vaccination with SARS-CoV-2 modRNA
- •b. Cohort 2: Siponimod treatment according to EU SmPC interrupting daily dosing for the purpose of vaccination with SARS-CoV-2 modRNA
- •c. Cohort 3: Dimethylfumarate, glatirameracetate, interferon, teriflunomode as per respective EU SmPC or no current treatment with diagnosis of SPMS or with RRMS at risk to develop SPMS (at the discretion of the treating physician)
- •3. Planning to receive a SARS-CoV-2 modRNA vaccination as part of clinical routine
- •4.No change regarding DMT within 4 weeks prior to inclusion to AMA-VACC, i.e. stable on current DMT according to dosing within label, no interruption, start or withdrawal of DMT in this period of time and no planned switch of DMT within following 2 months
- •5.Patients willing and eligible to receive a modRNA vaccine against COVID-19 as part of clinical routine
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. History of COVID-19
- •2. SARS-CoV-2 antibodies at screening
- •3. Patients likely not being able or willing to complete the study
- •4. Use of other investigational drugs within 5 half-lives of enrollment/initiation of study treatment (e.g. small molecules) or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer
- •5. Patients with any medical or psychological condition that, in the investigators opinion, renders the patient unable to understand the nature, scope, and possible consequences of the study and who are therefore not able to comply with the requirements of the study and capable of giving informed consent
- •6. No person directly associated with the administration of the study is allowed to participate as a study subject
- •7. No family member of the investigational study staff is allowed to participate in this study
- •8. Known or suspected clinically relevant allergy, intolerance or hypersensitivity to peanuts, soya (only cohort 1 and 2) or to any of the study treatments designated for the individual subject (DMTs or mRNA vaccines) or drugs of similar chemical classes (active substance or excipients)
- •9. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 10 days of study treatment after stopping medication.
- •10. For cohort 3: patients with contraindications for their current MS medication according to the respective EU SmPC
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