Treatment response and transition of anti integrin alpha v beta 6 antibody titers in patients of ulcerative colitis that have newly started treatment

Treatment response and transition of anti integrin alpha v beta 6 antibody titers in patients of ulcerative colitis that have newly started treatment - V6-VICTOR study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055869

Enrollment

510

Registered

2024-10-29

Start date

2024-09-12

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are at least 18 years of age at the time of consent 2) Patients who have given their free written consent to participate in the study after receiving full explanation 3) Patients with ulcerative colitis newly treated with 5-ASA, steroids (maximum daily dose of prednisolone >30 mg), molecular targeted drugs, tacrolimus, cyclosporine, granulocyte Patients with ulcerative colitis treated with granulocyte and monocyte adsorption apheresis

Exclusion criteria

Exclusion criteria: 1) Patients with undetermined diagnosis 2) Patients in remission at the start of observation 3) Patients after total colorectal resection 4) Patients with active malignancy 5) Pregnant and lactating patients 6) Patients who have not given consent for this study 7) Patients deemed inappropriate as research subjects by the principal investigator

Design outcomes

Primary

Measure	Time frame
Changes in anti integrin alpha V beta 6 antibody titers in the clinical remission and non-remission groups 6 to 8 weeks after treatment initiation	—

Secondary

Measure	Time frame
(a) Change in anti integrin alpha V beta 6 antibody titer 6 to 10 weeks after the start of each treatment (b) Correlation between disease activity and clinical test data at each observation point and anti integrin alpha V beta 6 antibody titer (c) Clinical remission rate and endoscopic remission rate at 46 to 58 weeks after treatment initiation in the antibody titer decrease group and the antibody titer non decrease group after 2 to 4 and 6 to 10 weeks after treatment initiation (d) Changes in anti integrin alpha V beta 6 antibody titer in the endoscopic remission group and the endoscopic non remission group after 46 to 58 weeks of treatment (e) Background factors in the anti integrin alpha V beta 6 antibody titer decrease group and the non-decrease group among cases that achieved clinical remission after 6 to 10 weeks of treatment (f) Relationship between changes in IgA in feces and anti integrin alpha V beta 6 antibody titers in the clinical remission and non remission groups (g) Relationship between changes in the expression of genes in peripheral blood mononuclear cells and anti integrin alpha V beta 6 antibody titers in the clinical remission and non remission groups	—

Measure

Time frame

(a) Change in anti integrin alpha V beta 6 antibody titer 6 to 10 weeks after the start of each treatment (b) Correlation between disease activity and clinical test data at each observation point and anti integrin alpha V beta 6 antibody titer (c) Clinical remission rate and endoscopic remission rate at 46 to 58 weeks after treatment initiation in the antibody titer decrease group and the antibody titer non decrease group after 2 to 4 and 6 to 10 weeks after treatment initiation (d) Changes in anti integrin alpha V beta 6 antibody titer in the endoscopic remission group and the endoscopic non remission group after 46 to 58 weeks of treatment (e) Background factors in the anti integrin alpha V beta 6 antibody titer decrease group and the non-decrease group among cases that achieved clinical remission after 6 to 10 weeks of treatment (f) Relationship between changes in IgA in feces and anti integrin alpha V beta 6 antibody titers in the clinical remission and non remission groups (g) Relationship between changes in the expression of genes in peripheral blood mononuclear cells and anti integrin alpha V beta 6 antibody titers in the clinical remission and non remission groups

—

Countries

Japan

Contacts

Public ContactYuta Shimomori

Sapporo Medical University School of Medicine Department of Gastroenterology and Hepatology

shimomori@oita-u.ac.jp011-611-2111

Outcome results