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

Not Applicable

• Conditions: ulcerative colitis (UC)

• Registration Number: JPRN-UMIN000043185
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-30
• Study Completion: 2022-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified