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

Takeda

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04873700

IBD-5010

U1111-1262-1609 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 335 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with moderate to severe CD or UC established for at least 6 months prior to Day 1 appointment, based on clinical, endoscopic or image criteria.
2. Participants aged 18 years or older (at the time of diagnosis of moderate to severe UC or CD).

Exclusion criteria

1. Has indeterminate or not classified colitis.
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Trial design

335 participants in 4 patient groups

Moderate to Severe Crohn's Disease

Description:

Participants diagnosed with moderate to severe Crohn's Disease (CD) were 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.

Mild to None Crohn's Disease

Description:

Participants diagnosed with mild to none activity of CD were 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.

Moderate to Severe Ulcerative Colitis

Description:

Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.

Mild to None Ulcerative Colitis

Description:

Participants diagnosed with mild to none activity of UC were 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.