Identification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD) - Immunological predictors of therapeutic response to vedolizumab

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO0 个研究点目标入组 40 人开始时间: 2019年3月20日最近更新: 2021年7月26日

适应症

试验速览

暂无简介。

•Key Inclusion Criteria (IBD patients):
•Patients with Crohn´s disease and ulcerative colitis qualified for vedolizumab therapy can be included.
•Key Inclusion Criteria (healthy controls):
•Healthy subject between 18 and 80 years old doing colonoscopy either for colorectal cancer screening or gastrointestinal symptoms
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Key Exclusion Criteria (IBD patients):
•1.Subjects <18 years or > 80 years
•2.History of malignancy in the previous 5 years
•3.Serious infections within 4 weeks prior to baseline or active chronic infections
•4.Pregnancy or lactation
•5.Any medical condition that could negatively impact on the participation to the study
•6.Therapy with any investigational or approved biologics within the last 60 days
•Key Exclusion Criteria (healthy controls):
•1.Subjects <18 years or > 80 years
•2.Serious infections within 4 weeks prior to baseline or active chronic infections
•3.Pregnancy or lactation
•4.Any medical condition that could negatively impact on the participation to the study, in particular previous diagnosis of cancer or IBD.
•5.Endoscopic signs of intestinal inflammation at baseline endoscopy, or detection of adenoma or colorectal cancer at screening endoscopy.

发起方