A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
| 대상 질환 | Multiple Sclerosis, Relapsing-Remitting |
|---|---|
| 임상 단계 | 3상 |
| 스폰서 | Mapi Pharma Ltd. |
| 상태 | 완료 |
| 참여자 수 | 1,016 명 |
| 중재(약물) | GA Depot |
| 시작일 | 2019년 9월 19일 |
| 완료일 | 2023년 6월 13일 |
| 결과 공개일 | 2026년 8월 5일 |
요약
A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks
Annualized Relapse Rate (ARR)
| Early Start: GA Depot 40 mg | 0.182 ± 0.022 Relapses per participant per year |
|---|---|
| Delayed Start: Placebo | 0.260 ± 0.029 Relapses per participant per year |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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