A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
| 対象疾患 | Multiple Sclerosis |
|---|---|
| 相 | 第3相 |
| スポンサー | Genzyme, a Sanofi Company |
| ステータス | 早期終了 |
| 参加者数 | 16 名 |
| 介入（薬剤） | Alemtuzumab GZ402673, Glatiramer acetate, Beta-Interferon, Methylprednisolone, Ranitidine |
| 開始日 | 2017年10月23日 |
| 完了日 | 2021年5月4日 |
| 結果公開日 | 2022年7月12日 |
概要
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 |
BENITIONS で見る ClinicalTrials.gov の原文を見る
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