A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
| 대상 질환 | Multiple Sclerosis |
|---|---|
| 임상 단계 | 3상 |
| 스폰서 | Genzyme, a Sanofi Company |
| 상태 | 조기 종료 |
| 참여자 수 | 16 명 |
| 중재(약물) | Alemtuzumab GZ402673, Glatiramer acetate, Beta-Interferon, Methylprednisolone, Ranitidine |
| 시작일 | 2017년 10월 23일 |
| 완료일 | 2021년 5월 4일 |
| 결과 공개일 | 2022년 7월 12일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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