An open label observational 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 sites120 target enrollmentJanuary 8, 2015

Overview

No summary available.

Registry

who.int

Start Date

January 8, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

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 6 weeks
•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 with vedolizumab.
•2\. Contraindication for endoscopy.
•3\. History of colonic dysplasia/cancer
•4\. Extensive colonic resection, i.e. subtotal or total colectomy with \<15 cm colon remaining
•5\. Received other biologics within the last 6 weeks of screening
•6\. Use of 5\-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
•7\. Chronic hepatitis B or C infection
•8\. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment
•9\. Active or latent tuberculosis
•10\. Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.