An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC

Academic Medical Center/ Gastroenterology0 个研究点目标入组 120 人2015年2月3日

概览

暂无简介。

注册库

who.int

开始日期

2015年2月3日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Academic Medical Center/ Gastroenterology

•1\. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
•2\. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
•3\. Age 18 to 80
•4\. Male or non\-pregnant, non\-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post\-menopausal \[defined as a minimum of one year since the last menstrual period]).
•5\. Established diagnosis of ulcerative colitis with histopathological confirmation available in the record of the patient.
•6\. Moderate to severe active UC (total Mayo score \> 6\) with objective evidence of inflammation that can be visualized on endoscopy. All endscopies will be video\-taped for later review, rereading and quality assurance. Patients must have an endoscopic Mayo score of 2 or 3\.
•7\. Anti\-TNF discontinued for at least 4 weeks at baseline
•8\. Written informed consent must be obtained and documented
•GROUP 1 (EARLY UC)
•1\.Diagnosis of UC \< 4 years prior to enrollment confirmed by clinical, endoscopic and histopathological evidence.

•1\. Prior treatment to any anti\-integrin antibodies including vedolizumab; alpha4beta7 antibodies; beta7 antibodies; anti\-MADCAM\-1\.
•2\. Contraindication for endoscopy.
•3\. History of colonic dysplasia or colonic cancer
•4\. Subjects with a pouch
•5\. Extensive colonic resection, i.e. subtotal or total colectomy with \<15 cm colon remaining
•6\. Received other biologics within the last 4 weeks from baseline
•7\. Early group: previous exposure to any anti\-TNF
•7\. Use of 5\-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
•8\. Chronic hepatitis B or C infection
•9\. Subjects with ALT or AST 3x the upper limit og normal measured at screening