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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-30

Study Completion Date

2022-05-17

Brief Summary

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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.

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Detailed Description

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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

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Inflammatory Bowel Diseases Colitis, Ulcerative Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Moderate to Severe Crohn's Disease

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.

No interventions assigned to this group

Mild to None Crohn's Disease

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.

No interventions assigned to this group

Moderate to Severe Ulcerative Colitis

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.

No interventions assigned to this group

Mild to None Ulcerative Colitis

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No