A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
| 适应症 | Multiple Sclerosis |
|---|---|
| 分期 | 3期 |
| 申办方 | Genzyme, a Sanofi Company |
| 状态 | 提前终止 |
| 受试者人数 | 16 人 |
| 干预（药物） | Alemtuzumab GZ402673, Glatiramer acetate, Beta-Interferon, Methylprednisolone, Ranitidine |
| 开始日期 | 2017年10月23日 |
| 完成日期 | 2021年5月4日 |
| 结果公布日 | 2022年7月12日 |
摘要
Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (\<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT. Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).
Brain Magnetic Resonance Imaging (MRI) Assessment: Adjusted Number of New or Enlarged T2 Lesions Per Month
| Period 1 | 3.53 lesions per month |
|---|---|
| Period 2 | 0.13 lesions per month |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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