A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice

Study Overview
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Brief Summary
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The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).

Detailed Description
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This is a non-interventional, retrospective and prospective study of participants with IBD. This study will collect data to provide accurate and comprehensive information related to treatment patterns associated with biologics use or non-biological therapy in participants with moderate to severe UC and CD in routine clinical practice. The study will have retrospective data collection from past records of participants within the last 2 years before participant's enrollment. The prospective part of the study will include one year of observation and data collection after the participant's enrollment in the study. The study will enroll approximately 2000 participants. Participants will be enrolled in one of the two groups: UC Participants CD Participants This multi-center trial will be conducted in Russia, Belarus and Kazakhstan. The overall period of observation in this study will be approximately 12 months. Participants will make 2 visits within their routine practice to the clinic after the enrollment into the study including a final visit at Month 12.

Official Title
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International, Multicentre, Non-Interventional Study To Evaluate Disease Control And Treatment Pattern In Patients With Moderate To Severe Inflammatory Bowel Disease In Real Life Practice

Conditions
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Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study. Has a moderate to severe IBD flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. IBD flare(s) must be confirmed in the source documentation. Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy. Exclusion Criteria: Current or previous (within the last two years) indeterminate or not classified colitis. Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years. Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial. Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UC Participants<br>Participants diagnosed with moderate to severe UC from approximately 35 investigational sites will be observed retrospectively for previous 2 years before enrollment until Visit 1 and will be observed prospectively for 1 year after participant's enrollment into the study to assess treatment patterns and treatment outcomes in UC participants particularly on the use of available biological therapies. | |
| CD Participants<br>Participants diagnosed with moderate to severe CD from approximately 35 investigational sites will be observed retrospectively for previous 2 years before enrollment until Visit 1 and will be observed prospectively for 1 year after participant's enrollment into the study to assess treatment patterns and treatment outcomes in CD participants particularly on the use of available biological therapies. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of UC and CD Participants Treated with Biologics Observed for Treatment Patterns | Treatment patterns planned to be observed in UC and CD participants treated with biologics according to drug name or drug type, initial dosage and changes during the course of treatment, overall duration of treatment, presence and reasons for interruption, and achievement of remission. | From 2 years before enrollment up to Month 12 (approximately 3 years) | 
| Percentage of UC and CD Participants Treated with Non-biological Treatment Observed for Treatment Patterns | Treatment patterns planned to be observed in UC and CD participants treated with non-biological treatment according to drug name or drug type, initial dosage and changes during the course of treatment, overall duration of treatment, presence and reasons for interruption, and achievement of remission. | From 2 years before enrollment up to Month 12 (approximately 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Methods for documentation of disease activity will include clinical, endoscopic, laboratory, and histological examinations. | From 2 years before enrollment up to Month 12 (approximately 3 years) | 
| Percentage of Participants Based on Objective UC and CD Disease Activity Assessment Using Different Methods |  | From 2 years before enrollment up to Month 12 (approximately 3 years) | 
| Percentage of Participants who Achieved Clinical and Combined Clinical and Endoscopic Remission | Treat to target (T2T) approach for UC includes clinical remission as a resolution of rectal bleeding and diarrhea/altered bowel habit, and endoscopic remission as Mayo endoscopic sub-score of 0 to 1. T2T approach for CD includes clinical remission as resolution of abdominal pain and diarrhea/altered bowel habit, and endoscopic remission for CD as resolution of ulceration at ileocolonoscopy or resolution of findings of inflammation on cross-sectional imaging in participants who cannot be adequately assessed with ileocolonoscopy. Mayo score is an instrument used to measure disease activity. Mayo score evaluates UC stage based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation and physician's global assessment. Each parameter of the score ranges from 0 (normal or inactive disease) to 3 (severe activity), with higher scores indicating more severe disease. | At enrollment, Months 6 and 12 | 
| Percentage of Participants with at least one Episode of Failure of Biological or Non-biological Therapy | Failure of biological or non-biological therapy would include episodes of dose escalation of biologics, switching to another therapy, IBD-related surgery, and medication augmentation. | From 2 years before enrollment up to Month 12 (approximately 3 years) | 
| Number of Participants Based on Treatment Decisions or Actions made after Making the Clinical Patterns of Treatment Decisions or Actions made after Assessment of IBD Activity Depending on Scenario of Achievement or Non-achievement of T2T Treatment Goals | Treatment decisions or actions depending on scenario of achievement or non-achievement of T2T treatment goals would include therapeutic de-escalation, escalation, without changes. | From 2 years of enrollment up to Month 12 (approximately 3 years) | 
| Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Challenges of implementing T2T strategy will include clinicians related factors, patient related factors and disease related factors. | From 2 years before enrollment up to Month 12 (approximately 3 years) | 
| Percentage of Participants with Hospitalizations due to Complications, IBD related Surgeries, and Disability Determination |  | From 2 years before enrollment up to Month 12 (approximately 3 years) | 
| Percentage of Participants with Surgical Treatment Based on Indications, Types of Surgeries and Complications |  | From 2 years before enrollment up to Month 12 (approximately 3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy