NCT04873700

A Study of Moderate to Severe Inflammatory Bowel Disease, Including Ulcerative Colitis (UC) and Crohn's Disease (CD)

Real-world Data of Moderate to Severe Inflammatory Bowel Disease (UC and CD) in Mexico: a Multicenter, Non-interventional Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Patient Reported Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 335 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to check the disease activity in people with moderate to severe ulcerative colitis and Crohn's disease. Participants will complete questionnaires about their disease and quality of life on Day 1 clinic visit. They will do this during a standard scheduled appointment with their doctor. Some of this study will also involve collecting information about participants from their medical records.

Detailed description

This is a retrospective, cross-sectional, and non-interventional study of participants with moderate to severe IBD (UC or CD). 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 UC or CD. 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 the management of UC or DC. The study will enroll approximately 335 participants. All participants will be enrolled in one observational cohort. This multi-center trial will be conducted in Mexico. The overall time for data collection in the study will be approximately 3 years before the start of the study (Day 1).

Conditions

• Inflammatory Bowel Diseases
• Colitis, Ulcerative
• Crohn Disease

Timeline

• Start date: 2021-08-30
• Primary completion: 2022-05-17
• Completion: 2022-05-17
• First posted: 2021-05-05
• Last updated: 2024-11-07
• Results posted: 2024-11-07

Locations

12 sites across 1 country: Mexico