Vedolizumab-4030: Understand the Outcomes of Inflammatory Bowel Disease (IBD) Patients Treated with Biologics in Taiwan – A Decentralized Vedolizumab and Biologic Agents Core Assessments in IBD Collaboration
About this clinical trial
The main objective of this study is to quantify the relapse rate after biologic discontinuation, and identify predictors of relapse. Additionally, treatment safety and effectiveness of biologics including anti-TNF-α and vedolizumab in IBD patients will be quantified, along with predictors of response to treatment.
At a glance
What medical conditions were being studied?
How many participants were enrolled?
423
Were placebos part of the clinical trial?
No
When was the clinical trial conducted?
May 2021 - Dec 2022
Key requirements
Sex
All
Age
18+ years
Healthy volunteers?
No
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.