An open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD

Academic Medical Center, Gastroenterology0 sites260 target enrollmentAugust 30, 2017

Overview

No summary available.

Registry

who.int

Start Date

August 30, 2017

End Date

TBD

Last Updated

8 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 ileal, ileocolonic or colonic Crohn’s disease with histopathological confirmation available in the record of the patient.
•6\. Moderately to severely active CD (CDAI 220\-450\) with objective evidence of ulcerations visualized on endoscopy.
•7\. Anti\-TNF discontinued for at least 4 weeks prior to baseline.
•GROUP 1 (EARLY CD):
•8\. Diagnosis of CD \< 24 months prior to enrollment.

•1\. Previous exposure to any anti\-integrin antibodies including vedolizumab, a4ß7 antibodies, ß7 antibodies, anti\-MADCAM\-1\.
•2\. Contraindication for endoscopy.
•3\. History of colonic dysplasia or colonic cancer.
•4\. Presence of stoma.
•5\. Subjects with a pouch.
•6\. Received other biologics within the last 4 weeks of baseline.
•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 of normal measured at screening.
•10\. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment.