A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis [M14-033]

AbbVie GK0 个研究点目标入组 952 人开始时间: 2014年9月3日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: AbbVie GK
入组人数: 952

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

umerically greater efficacy for higher induction dosing regimen was demonstrated compared with standard induction dosing regimen. At Week52, clinical remission among Week8 responders was significantly higher with adalimumab 40mg EW vs 40mg EOW. All dosing regimens were well tolerated.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 <= 75age old（—）
性别: All

入选标准

•1.Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy with biopsy during Screening period.
•2.Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.

排除标准

•1.Subject with Crohn's disease (CD) or indeterminate colitis (IC).
•2.Current diagnosis of fulminant colitis and/or toxic megacolon.
•3.Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
•4.Chronic recurring infections or active Tuberculosis (TB).

研究者

发起方

AbbVie GK

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