A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis - A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis

Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology0 sites60 target enrollmentJanuary 4, 2021

Conditionsulcerative colitis

Overview

Phase: 未知
Intervention: Not specified
Conditions: ulcerative colitis
Sponsor: Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
Enrollment: 60
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 4, 2021

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•\[All subjects] 1\.Subjects with a history of extensive colonic resection, subtotal or total colectomy 2\.Subjects with a history of ileostomy, colostomy, or symptomatic intestinal stricture \[Subjects with UC] 1\.Subjects with UC that are classified as predominant proctitis 2\.Subjects who had received any of the following drugs within the designated period prior to the initial administration of vedolizumab: infliximab (8 weeks), adalimumab (2 weeks), golimumab (4 weeks), tofacitinib (1 week), and ustekinumab (8 weeks) 3\.Subjects with prior exposure to vedolizumab, natalizumab, efalizumab or anti\-CD20 antibodies (e.g., rituximab, ofatumumab and obinutuzumab) 4\.Subjects with any evidence of an active infection within 1 month prior to the first administration of vedolizumab 5\.Subjects previously diagnosed as having PML or subjects with symptoms suggestive of PML 6\.Subjects with concurrent malignancies who are deemed unsuitable for enrollment by the investigator (e.g., Eastern Cooperative Oncology Group performance status of 2 or more, or are receiving cytotoxic chemotherapy, molecularly targeted therapy, or immune checkpoint inhibitors) 7\.Subjects with a history of hypersensitivity reaction to vedolizumab or its components (subjects with contraindication in the vedolizumab package insert) 8\.Subjects who are pregnant, are susceptible to being pregnant, are planning to be pregnant, or are lactating \[Subjects without UC] 1\.Subjects with inflammatory bowel diseases, autoimmune disorders or connective tissue diseases