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中國抗體-B(03681.HK)完成SM03III期臨牀試驗中期分析
格隆匯 06-22 22:58

格隆匯 6 月 22日丨中國抗體-B(03681.HK)公告,關於SM03在中國的III期臨牀試驗,公司一直在進行臨牀試驗研究(III期研究),以多中心隨機、雙盲法、安慰劑對照、平行組研究方式評估SM03在活動性類風濕關節炎患者中的臨牀療效及長期安全性。董事會欣然宣佈,截止2020年6月19日,290名合資格患者已隨機加入臨牀試驗及III期臨牀試驗中期分析已完成。

次SM03III期臨牀研究的中期分析目的在於基於現有的SM03安全性信息評價研究中已入組患者的安全性和耐受性,以保護研究受試者的利益(III期研究的中期分析)。

III期臨牀研究期分析由獨立數據監測委員會進行評價,其成員均為相關醫學領域的資深專家。通過在非盲狀態下審核當前收集到的III期臨牀研究中所收集的不良事件數據,iDMC成員能夠判斷和確定在目前的病人安全性數據中是否出現新的安全性信號。

此外,III期研究的臨牀數據對參與研究的研究者和公司(作為研究的申辦方)仍然保持盲態。

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