A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea

Phase

N/A

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Ulcerative Colitis (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05428345

VedolizumabSC-4003

Ages > 18
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

With moderately to severely active UC or CD, who have had an inadequate responsewith, lost response to, or were intolerant to either conventional therapy or a TNF-αantagonist
With evidence of therapeutic benefit after at least 2 vedolizumab intravenousinfusions

Exclusion

Exclusion Criteria:

With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing andincreased heart rate to the vedolizumab substance or to any of its excipients
With active severe infections such as tuberculosis, cytomegalovirus, sepsis,listeriosis and opportunistic infections such as Progressive MultifocalLeukoencephalopathy (PML)
For whom vedolizumab SC is contraindicated as per product label

Study Design

September 25, 2023

November 30, 2027

Study Description

This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:

• Participants with UC or CD

This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Connect with a study center

Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do 10326
Korea, Republic of
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.