NL-OMON49585撤回3 期
A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) - LEMKIDS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 1
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
- 2 至 17（—）
入选标准
- •-Patients with RRMS aged from 10 years to less than 18 years at study entry are
- •eligible. Patients must meet the criteria of diagnosis of MS as defined by the
- •International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for
- •pediatric MS and the criteria of MS based on McDonald criteria 2010.
- •-Signed informed consent/assent obtained from patient and patient*s legal
- •representative (parent or guardian) according to local regulations.
- •-Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at
- •-At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last
- •year during treatment with a interferon-beta (IFNB) or glatiramer acetate (GA)
- •after having been on that therapy for at least 6 months
- •-At least 1 of the following:
- •-*1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion*
- •while on that same prior therapy (IFNB or GA), OR
- •-Two or more relapses in the prior year, OR
- •-Tried at least 2 MS DMTs.
排除标准
- •-Any prior exposure to alemtuzumab.
- •-Any progressive or nonrelapsing form of MS.
- •-Treatment with natalizumab, daclizumab, fingolimod, methotrexate,
- •azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months, or
- •as determined by the treating physician to have residual immune suppression
- •from these or other MS treatments.
- •-Treatment with teriflunomide in the last 12 months except if the patient
- •underwent the accelerated elimination procedure as per local teriflunomide
- •-Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab,
- •ocrelizumab, leflunomide or any cytotoxic therapy.
- •-CD4+, CD8+, or CD19+ absolute cell count in blood at screening below lower
- •limit of normal (LLN).
- •-Prior documented history of thrombocytopenia, or platelet count at screening
研究者
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