NCT02822235

Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil

Real-world Data of Moderate to Severe Inflammatory Bowel Disease in Brazil: a Non-interventional, Multicenter Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life (RISE BR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 407 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to gather information regarding the population with moderate to severe inflammatory bowel disease (IBD), the burden of the disease, and understand their treatment patterns, particularly on the use of available biologic therapies.

Detailed description

This is a non-interventional study to determine the rate of control of disease activity in moderate to severe inflammatory bowel disease (IBD) participants, with two parts: cross-sectional evaluation (Day 1) with retrospective data collection and a prospective 12-month evaluation for patients with active IBD at cross-sectional evaluation (Day 1). The study enrolled 407 patients. This multicenter trial was conducted in Brazil. Retrospective data of previous IBD treatments (drug, dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years will be collected. Prospective data was collected for a period of 12 months in participants with active disease. UC participants, with no or light disease activity at Day 1 did not continue to 12-month follow up. CD participants, with no or light disease activity at Day 1 but with colonoscopy or calprotectin levels (i.e, calprotectin \>200 ug/g) in the previous year suggestive of inadequate control of activity progressed to 12-month follow up.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
OTHER	No Intervention

Timeline

• Start date: 2016-10-11
• Primary completion: 2018-02-05
• Completion: 2018-02-19
• First posted: 2016-07-04
• Last updated: 2020-02-25
• Results posted: 2020-02-25

Locations

13 sites across 1 country: Brazil