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

Study Overview
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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.

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).

Official Title
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Real-world Data of Moderate to Severe Inflammatory Bowel Disease (UC and CD) in Mexico: a Multicenter, Non-interventional Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Patient Reported Outcomes

Conditions
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Crohn Disease, Inflammatory Bowel Diseases, Colitis, Ulcerative

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Participants aged 18 years or older (at the time of diagnosis of moderate to severe UC or CD). Exclusion Criteria: Has indeterminate or not classified colitis. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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 |
| --- | --- |
| All Participants<br>Participants diagnosed with moderate to severe UC or CD 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC and CD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Active CD at Day 1 | Percentage of participants with active CD observed, where active CD will be defined as Harvey Bradshaw index (HBI) greater than or equal to (>=) 8 or Crohn's disease active index (CDAI) >=220. CDAI assesses CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI score is used to measure disease activity of CD and consists of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicates more severe disease. | Day 1 | 
| Percentage of Participants with Active UC at Day 1 | Percentage of participants with active disease UC disease will be observed, where UC is defined as 9-point Partial Mayo Score (pMayo score) >=5. The Mayo score is composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0 to 2), having mild activity (pMayo of 3 or 4) or moderate to severe activity (pMayo of >=5). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With UC or CD Based on Clinical Presentation | Number of participants will be reported based on the clinical presentations (extent of inflammation and severity for UC participants, and location, behavior, perianal disease, achievement of ileal disease for CD participants). | Day 1 | 
| Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Number of participants will be reported based on the IBD therapies which include aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics, probiotics and surgeries. | From 3 years prior to Day 1 until Day 1 | 
| Duration of IBD Therapies | Time between the beginning of IBD therapy until the end of treatment or Day 1, whichever comes first. IBD therapies include aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics, probiotics and surgeries. | From 3 years prior to Day 1 until Day 1 | 
| Percentage of Participants With UC or CD Based on Biologic-experience | Percentage of participants who have experienced any biologic therapy (examples, infliximab, adalimumab, golimumab, ustekinumab, certolizumab) once or more than once according to medical history until the day 1. | From 3 years prior to Day 1 until Day 1 | 
| Percentage of Participants With UC or CD who Have not Responded Previously to Biologic Therapies |  | From 3 years prior to Day 1 until Day 1 | 
| Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies |  | From 3 years prior to Day 1 until Day 1 | 
| Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 |  | Day 1 | 
| Number of Participants With HBI >=8 or CDAI >=220 Points Versus HBI <8 or CDAI <220 Points Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in CD Participants | CDAI assesses clinical signs and symptoms: number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0-600 points. Higher score indicates more severe disease. HBI score measures disease activity of CD based on 5 clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicates more severe disease. Socio-demographic variables will include age, sex, professional status, educational level, participant income. Clinical variables will include duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and EIM. | Day 1 | 
| Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants | Mayo score is composed of 4 categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0-2), having mild activity (pMayo of 3-4) or moderate to severe activity (pMayo >=5). Socio-demographic variables will include age, sex, professional status, educational level, participant income. Clinical variables will include duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and extraintestinal manifestations (EIM). | Day 1 | 
| Mean Score of Components of 36-item Short Form health Survey (SF-36) of UC or CD Participants | SF-36 is a general quality of life (QoL)-questionnaire, which evaluates 8 health dimensions: physical functioning, bodily pain, role physical (limitations due to physical problems), role emotional (limitations due to personal or emotional problems), mental health, social functioning, vitality, and general health perceptions. Based on these 8 dimensions, two weighted scores are generated: the physical component summary (PCS) score and the mental component summary (MCS) score. Scores range between 0 and 100, with higher scores indicating a better quality of life. Mean score of each components (physical component and mental component) will be reported. | Day 1 | 
| Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants | IBDQ is a disease-specific questionnaire with 32 items that measures four dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presents seven possible answers/points. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The sub-score ranges from 8 to 56 and thus the total score ranges from 32 to 224, where higher score indicates better quality of life. | Day 1 | 
| Mean Total Percentage of Work Impairment Assessed by Work Productivity and Activity Impairment questionnaire (WPAI) in UC or CD Participants | WPAI assesses the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants will be evaluated for this outcome measure. Mean total percentage of work impairment (absenteeism and presentisms) will be reported in terms of hours. | The last 7 days prior to Day 1 | 
| Mean Work Time Missed Assessed by WPAI in UC or CD Participants | WPAI assesses the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants will be evaluated for this outcome measure. Mean work time missed (absenteeism) will be reported. | The last 7 days prior to Day 1 | 
| Mean Impairment While Working Assessed by WPAI in UC or CD Participants | WPAI assesses the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants will be evaluated for this outcome measure. Mean impairment while working (presentisms) will be reported. | The last 7 days prior to Day 1 | 
| Mean Total Activity Impairment Assessed by WPAI in UC or CD Participants | WPAI assesses the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants will only answer to questions related to employment status and regular activities impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Mean total activity impairment will be reported. | The last 7 days prior to Day 1 | 
| Percentage of Participants With UC or CD Who Quit Their Job due to IBD and Unable to Return to Work |  | Day 1 | 
| Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Healthcare resources includes use of surgeries, hospitalizations, medical appointments, imaging and laboratory testing. | From 3 years prior to Day 1 until Day 1 | 
| Number of Participants With UC or CD Based on Direct Medical Cost | Direct costs will be obtained by multiplying resource use with relevant unit costs, consisting of 2 components: (1) Health care costs: Consumer price index (CPI)-adjusted IBD (UC or CD)- related health care costs computed as total costs, medical costs, UC and CD drug costs, and other costs (sum of surgeries, hospitalization, medical appointments; imaging and laboratory testing costs). (2) Treatment pattern costs: calculated as total UC or CD-related health care costs, stratified by the defined treatment patterns. | From 3 years prior to Day 1 until Day 1 | 
| Number of Participants With UC or CD Based on Indirect Cost | The indirect costs will be reported as the cost of productivity loss by absenteeism and presentisms per participant. Human capital method will be used to calculate indirect costs as exactly the cost of the salary paid to the employee (participant) proportionally to the hours of absence/ work impairment based on the average incomes and the absence/impaired work hours reported during the study. This outcome measure will be evaluated only for participants with employment (active workers). | From 3 years prior to Day 1 until Day 1 | 

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