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

Last updated: January 18, 2023
Sponsor: Takeda
Overall Status: Completed

Phase

N/A

Condition

Inflammatory Bowel Disease

Ulcerative Colitis

Ulcerative Colitis (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05596422
Vedolizumab-4030
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, ClinicalModification [ICD-9-CM]: 555.X or International Classification of Diseases, TenthRevision, Clinical Modification [ICD-10-CM]: K50.XX, K50.XXX)
  • UC (ICD-9-CM: 556.X or ICD-10-CM: K51.XX, K51.XXX).
  1. Had received any dose of biologics for IBD treatment, including vedolizumabadalimumab, infliximab or golimumab, from February 2008 to March 2020 (or per localIRB permitted date).

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 423
Study Start date:
May 27, 2021
Estimated Completion Date:
December 08, 2022

Study 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.

Connect with a study center

  • China Medical University Hospital

    Taichung, 404327
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100229
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital-Linkou

    Taoyuan, 333
    Taiwan

    Site Not Available

Map preview placeholder

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.