A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis

Takeda

Status: Completed

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04799496

Vedolizumab-4023

Details and patient eligibility

About

In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.

The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).

Full description

This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (ulcerative colitis (UC) or Crohn's disease (CD)), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist or participants with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis (IPAA) for UC, and have had an inadequate response with, or lost response to antibiotic therapy. This study will evaluate the safety and effectiveness of Kynteles injection (Vedolizumab) in a routine clinical practice setting under real world conditions.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic case report forms (e-CRFs).

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

Enrollment: 688 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. With moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.

Exclusion criteria

1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the Kynteles Injection (Vedolizumab) or to any of its excipients
2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML)
3. Treated with Kynteles Injection (Vedolizumab) outside of the locally approved label in South Korea.

Trial design

688 participants in 1 patient group

Kynteles Injection (Vedolizumab)

Description:

Participants 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 tumor necrosis factor-alpha (TNF-α) antagonist or participants with pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy and have initiated Kynteles injection (Vedolizumab) treatment in a routine clinical practical setting in South Korea, will be observed prospectively.