The relationship between serum concentration of an inflammatory biomarker for intestinal mucosal status, inflammatory cytokines and clinical efficacy following vedolizumab IV treatment in Japanese subjects with moderately to severely active ulcerative colitis - The relationship between serum concentration of an inflammatory biomarker for intestinal mucosal status, inflammatory cytokines and clinical efficacy following vedolizumab IV treatment in Japanese subjects with moderately to severely active ulcerative colitis

Takeda Pharmaceutical Company Limited0 sites22 target enrollmentJanuary 30, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 30, 2021

End Date

February 28, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

•1\) Subjects who underwent extensive resection; subjects who underwent subtotal or total colectomy 2\) Subjects with ulcerative colitis classified as predominant proctitis 3\) Subjects with a history of ileostomy, colostomy, or symptomatic intestinal stricture 4\) Subjects who had received any of the following drugs within the following periods prior to the initial administration of vedolizumab: infliximab (8 weeks), adalimumab (2 weeks), golimumab (4 weeks), tofacitinib (1 week), and ustekinumab (8 weeks) 5\) Subjects who had received vedolizumab, natalizumab, efungumab; or anti\-CD20 antibody preparations, such as rituximab, ofatumumab, and obinutuzumab 6\) Subjects who had an active infection within a month before the date of informed consent 7\) Subjects with a history of hypersensitivity or allergy to vedolizumab or additives contained in vedolizumab preparations 8\) Subjects who have malignant tumors or a history of malignant tumors 9\) Subjects who were pregnant or thought they were pregnant; subjects who were trying to get pregnant; subjects who were breastfeeding