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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043185

Enrollment

Registered

2021-01-30

Start date

2021-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis (UC)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects who were diagnosed with ulcerative colitis at least 3 months before the date of informed consent 2) Subjects who are scheduled to receive initial administration of vedolizumab 3) Subjects with a partial Mayo score >=4 and a bloody stool score >=1 within 28 days of the scheduled initial administration of vedolizumab 4) Subjects who experienced treatment failure with at least one of the pretreatment drugs listed below Corticosteroids - Resistance - Dependence - Intolerance Immunomodulators (azathioprine or 6-mercaptopurine) - Refractory cases - Intolerance Biologics (anti-TNF-alpha antibody or ustekinumab) - Inadequate response - Loss of response - Intolerance Tofacitinib - Refractory cases - Intolerance 5) Subjects who are 18-80 years old at date of informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The relationship between the serum concentration of an inflammatory biomarker for intestinal mucosal status and therapeutic efficacy at 14 weeks	—

Countries

Japan

Contacts

Public ContactYuki Makino

Mebix, Inc. Devision of Study promotion

yuki.makino@mebix.co.jp06-6226-0657

Outcome results