None listed
Conditions
Interventions
Drug : The subjects to be recruited consist of 30 patients with Crohn’s disease and 30 patients with ulcerative colitis (considering dropout rate of 20%).
Crohn’s disease (CD): If a subject does not
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged = 19 years to = 70 years 2) Patients with moderate-to-severe active Crohn's disease or ulcerative colitis who are unresponsive to, become unresponsive to, or have no tolerability to universal treatment (with corticosteroids, immunomodulators, etc.) - CDAI (Crohn’s Disease Activity Index) = 220 for Crohn's disease - Complete Mayo score = 6 for ulcerative colitis
Exclusion criteria
Exclusion criteria: 1) A history of total colectomy 2) Acute severe UC 3) A potential for a bowel resection surgery within 3 months 4) Pregnancy and breastfeeding 5) Prior use of any biologics including anti-TNFs, ustekinumab, and tofacitinib. 6) A history of solid cancer and blood cancer within 5 years 7) Positive for active or latent tuberculosis (However, screening is possible if active tuberculosis is excluded and after at least 4 weeks of latent tuberculosis treatment.) 8) Active severe infections such as sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML). 9) Hypersensitivity to vedolizumab or its substances (e.g., dyspnoea, bronchospasm, redness, and increased heart rate) 10) Experience of treatment with a drug or a medical device due to participation in another clinical trial within 3 months from the date of consent 11) A woman of childbearing potential who has a positive pregnancy test (Urine-hCG or Serum hCG) at a screening visit or does not agree to use at least one of medically acceptable, effective contraceptive methods*. However, females who reached menopause at least one year ago or turned out infertile due to an operation should be excluded. *Effective contraceptive methods: intrauterine devices (e.g., IUD, mirena), dual barrier methods (diaphragm or condom/femidom + spermicide), and parenteral contraceptives. Continuing only sexual abstinence is not viewed as an acceptable method. 12) A woman of childbearing potential who neither practices adequate contraception nor agrees to continue its use for at least 18 weeks after the last dose of the study drug. 13) Those decided by the investigator to be not eligible for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate (%) at 14 weeks after commencement of vedolizumab treatment in induction phase;Clinical remission rate (%) at 54 weeks in maintenance phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of dose intensification at 54 weeks in inadequate responders at 6 weeks;Mucosal healing rate at 14 weeks and 54 weeks;Steroid free remission rate at 54 weeks;Transmural healing rate at 14 weeks and 54 weeks for Crohn's disease;Factors associated with clinical remission at 54 weeks;Changes in fecal microbiota after vedolizumab treatment: Microbiota change will be compared with baseline status using a diversity and ß diversity.;Quality of life: Inflammatory Bowel Disease Questionnaire;Incidence and frequency of Adverse event;laboratory tests | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Hee Cheon
Yonsei University Health System, Severance Hospital
Outcome results
None listed