A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease

CB Japan Co., Ltd.0 个研究点目标入组 100 人开始时间: 2015年3月5日最近更新: 2015年3月9日

适应症

试验速览

暂无简介。

•- Patients who are diagnosed with Crohn's disease (according to the Crohn’s disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
•- Patients with Crohn’s Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
•- C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Stoma patient
•- Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
•- Patients who participated in a clinical study with CDP870
•- Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
•- Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators

发起方

CB Japan Co., Ltd.