NCT03488030

A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)

Real-world Data of Moderate to Severe Inflammatory Bowel Disease in Argentina: A Non-interventional, Multicenter Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 246 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.

Detailed description

This is a retrospective, cross-sectional, and non-interventional study of participants with IBD. The study will have a cross-sectional evaluation on Day 1 to provide the real-world data of disease activity, treatment patterns, burden of disease and quality of life in participants with moderate to severe CD or UC. The study will involve an additional retrospective review of medical charts of participants of previous 3 years to describe the IBD treatments and use of other healthcare resources related with management of IBD. The study will enroll approximately 246 participants. All participants will be enrolled in one observational cohort. This multi-center trial will be conducted in Argentina. The overall time for data collection in the study will be approximately 3 years before the start of the study (Day 1).

Conditions

• Crohn Disease
• Colitis, Ulcerative
• Inflammatory Bowel Disease

Timeline

• Start date: 2018-12-12
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2018-04-04
• Last updated: 2022-02-08
• Results posted: 2020-06-12

Locations

7 sites across 1 country: Argentina