Efficacy and Safety of vedolizumab in biologic-naïve Korean patients with moderate to severe inflammatory bowel disease

Recruitment & Eligibility

Status: Withdrawn

Sex: All

Target Recruitment: 60

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

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical remission rate (%) at 14 weeks after commencement of vedolizumab treatment in induction phase;Clinical remission rate (%) at 54 weeks in maintenance phase

Secondary Outcome Measures

Name	Time	Method
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