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) (RISE AR)

Takeda

Status: Completed

Conditions: Colitis, Ulcerative; Inflammatory Bowel Disease; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03488030

IBD-5004

U1111-1207-4110 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment based on clinical or endoscopic or image criteria.

Exclusion criteria

1. Indeterminate or not classified colitis.
2. Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Trial design

246 participants in 1 patient group

All Participants

Description:

Participants diagnosed with moderate to severe UC or CD from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC or CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.