NCT05596422

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 423 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2021-05-27
• Primary completion: 2022-10-27
• Completion: 2022-12-08
• First posted: 2022-10-27
• Last updated: 2023-01-19

Locations

4 sites across 1 country: Taiwan