Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• With moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist

• With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions

Locations
Other Locations
Republic of Korea
Donggguk University Ilsan Hospital
RECRUITING
Goyang-si
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2023-09-25
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 600
Treatments
Participants With UC or CD
Participants diagnosed with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist and have initiated treatment with vedolizumab in a routine clinical practical setting in South Korea, will be observed prospectively for 52 weeks.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov