ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
- Setsunan University - Institute of Physical and Chemical Research(RIKEN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Criteria for Inclusion: [Subjects with UC] -Subjects with a diagnosis of UC at least 3 months prior to informed consent -Subjects who have been scheduled to receive initial administration of vedolizumab IV -Subjects with a partial Mayo score of 5 to 9, inclusive, at screening -Subjects who meet the following treatment failure criteria with at least one of the following agents: >Resistant, dependent, or intolerant to corticosteroids >Refractory or intolerant to immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)or 5-ASA >Inadequate response, loss of response, or intolerance to biological agents (anti-TNFa antibodies or ustekinumab) or tofacitinib -Subjects aged 18 to 80 years, inclusive, at informed consent [Subjects without UC] -Subjects who have been scheduled to undergo colonoscopy for disease monitoring following resection of colonic adenomas and/or hyperplastic polyps -Subjects aged 18 to 80 years, inclusive, at informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - LCI classification at Week 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| - LCI classification at Week 54 - LCI index at Weeks 22 and 54 - Proportion of subjects with clinical remission, mucosal healing and histologic remission at Weeks 22 and 54 - Association between LCI classification and clinical remission, mucosal healing or histologic remission at Weeks 22 and 54 - Association between changes in LCI classification from Week 0 (baseline) to Week 22 and clinical remission, mucosal healing or histologic remission at Week 22 - Association between changes in LCI classification from Week 0 (baseline) to Weeks 22 or 54, and clinical remission, mucosal healing or histologic remission at Week 54 - Association between changes in LCI classification from Week 22 to Week 54 and clinical remission, mucosal healing or histologic remission at Week 54 - Relationship between LCI index and clinical remission, mucosal healing or histologic remission at Weeks 22 and 54 - Relationship between changes in LCI index from Week 0 (baseline) to Week 22 and clinical remission, mucosal healing or histologic remission at Week 22 - Relationship between changes in LCI index from Week 0 (baseline) to Weeks 22 or 54, and clinical remission, mucosal healing or histologic remission at Week 54 - Relationship between changes in LCI index from Week 22 to Week 54 and clinical remission, mucosal healing or histologic remission at Week 54 | — |
Countries
Japan
Contacts
Public ContactKazuhiko Uchiyama
Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
Outcome results
None listed