Clinical trial NCT05596422: A Study of Vedolizumab and Biologic Agents in Participants With Inflammatory Bowel Disease (IBD)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease (IBD)
Ulcerative Colitis
Crohn's Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed IBD participants treated with biologics including vedolizumab, adalimumab, infliximab, or golimumab will be included in this study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Had IBD Relapse
timeFrame: Up to approximately 13 years
measure: Time to Relapse After Biologics Discontinuation
timeFrame: Up to approximately 13 years
measure: Correlation Between the Clinical Variables and Relapse Post Biologics Discontinuation
timeFrame: Up to approximately 13 years
measure: Percentage of Participants Achieving Clinical Response
timeFrame: Up to approximately 13 years
measure: Percentage of Participants Achieving Clinical Remission
timeFrame: Up to approximately 13 years
measure: Percentage of Participants Achieving Steroid-free Remission
timeFrame: Up to approximately 13 years
measure: Percentage of Participants Achieving Mucosal Healing
timeFrame: Up to approximately 13 years
measure: Correlation Between the Clinical Variables and Treatment Effectiveness
timeFrame: Up to approximately 13 years
measure: Percentage of Participants Experiencing Infection
timeFrame: Up to approximately 13 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital-Linkou
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: