A Study of Vedolizumab and Biologic Agents in Participants With Inflammatory Bowel Disease (IBD)

Takeda

Status: Completed

Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis; Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05596422

Vedolizumab-4030

Details and patient eligibility

About

This is a non-interventional, retrospective study of adult participants with IBD. IBD consists of either ulcerative colitis (UC) or Crohn's disease (CD). The study will review the clinical data previously collected during February 2007 to March 2020 of approximately 724 participants who have had treatment with adalimumab, infliximab, golimumab, or vedolizumab in Taiwan.

Full description

This is a non-interventional, retrospective study in newly diagnosed IBD participants (UC or CD) treated with biologics.

The study will assess IBD relapse, effectiveness, and safety of biologic treatments in IBD participants. The study will enroll approximately 724 participants. The data will be collected from the electronic medical record (EMR) database of selected medical centers in Taiwan. IBD Participants who were evaluated and treated at the participating sites between 01 February 2007 to 31 March 2020 will be included. Participants will be assigned to the following two observational cohorts based on pathological diagnosis:

• Cohort 1: Participants With Biologics Discontinuation
• Cohort 2: Participants Treated With Biologics

This multi-center trial will be conducted in Taiwan. The overall duration of the study will be approximately 15 months.

Enrollment: 423 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed during February 2008 to March 2020 (or per local institutional review board [IRB] permitted date).

   • CD (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]: 555.X or International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM]: K50.XX, K50.XXX)
   • UC (ICD-9-CM: 556.X or ICD-10-CM: K51.XX, K51.XXX).

2. Had received any dose of biologics for IBD treatment, including vedolizumab adalimumab, infliximab or golimumab, from February 2008 to March 2020 (or per local IRB permitted date).

Exclusion criteria

1. Participants with any suspected diagnosis of CD or UC within one year before the initial date of confirmed IBD diagnosis will be excluded.

Trial design

423 participants in 2 patient groups

Cohort 1: Participants With Biologics Discontinuation

Description:

Participants with IBD (UC or CD) who had received biologic treatments for at least 6 months after the initial confirmed diagnosis of IBD, and with at least 3 months follow-up period after biologics discontinuation will be observed retrospectively.

Cohort 2: Participants Treated With Biologics

Description:

Participants with IBD (UC or CD) who had any dose of biologic for IBD treatment after the initial confirmed diagnosis of IBD will be observed retrospectively.