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)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-12

Study Completion Date

2019-05-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Crohn Disease Colitis, Ulcerative Inflammatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All Participants

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No