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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-27

Study Completion Date

2022-12-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammatory Bowel Disease (IBD) Ulcerative Colitis Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1: Participants With Biologics Discontinuation

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.

No interventions assigned to this group

Cohort 2: Participants Treated With Biologics

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.

No interventions assigned to this group

Eligibility Criteria

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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).