EUCTR2014-003669-97-BE进行中（未招募）1 期
A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.
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
- Biogen Idec
- 入组人数
- 10
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.Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorizations required by local law in accordance with national and local subject privacy regulations.
- •2.Has participated in the STRATA Study, have stable disease and do not meet reimbursement criteria for natalizumab (Tysabri®) in Belgium, upon termination of the STRATA Study.
- •3.Are =18 years old.
- •4.Subjects of child bearing potential must practice effective contraception during the study and be able to continue contraception for 3 months after their last infusion.
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Patients participating in STRATA who were in line with current Belgian reimbursement criteria when they started in one of the feeder studies (Affirm or Sentinel).
- •2.Subjects with any significant change in clinical status, that in the opinion of the Investigator, would make them unsuitable to participate in this study. The investigator must review the subject’s medical fitness for participation and consider any diseases that would preclude treatment.
- •3.Subjects that are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
- •4.Female Subjects who are considering becoming pregnant while in the study.
- •5.Female Subjects of childbearing potential and are not using the appropriate contraception as determined by the Investigator.
- •6.Female subjects who are currently pregnant or breastfeeding.
- •7.Any prescheduled elective procedure during the study period that, in the opinion of the Investigator, would interfere with study parameters.
- •8.Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study
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