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

Completed

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

• Registration Number: NCT04873700
• Lead Sponsor: Takeda

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-05
• Study Start: 2021-08-30
• Primary Completion: 2022-05-17
• Study Completion: 2022-05-17
• Results First Submitted: 2023-05-11
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Results First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Active CD at Day 1	Day 1	Percentage of participants with active CD observed, where active CD was defined as Harvey Bradshaw index (HBI) greater than or equal to (\>=) 8 or Crohn's disease active index (CDAI) \>=220. CDAI assessed 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 was used to measure disease activity of CD and consisted 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 indicate more severe disease. Percentages are rounded off to whole number at the nearest decimal.
Percentage of Participants With Active UC at Day 1	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With CD Based on Clinical Presentation	Day 1	Number of participants will be reported based on the clinical presentations (location, behavior, perianal disease, achievement of ileal disease and extraintestinal manifestations for CD participants). Clinical presentations that have data for at least one participant in the below categories are reported. Data is reported for participants with CD only.
Number of Participants With UC Based on Clinical Presentation	Day 1	Number of participants will be reported based on the clinical presentations (location, behavior, and extraintestinal manifestations,). Clinical presentations that have data for at least one participant in the below categories are reported. Data is reported for participants with UC only.
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies	From 3 years prior to Day 1 until Day 1	Number of participants will be reported based on the IBD therapies which include aminosalicylates, steroids, immunomodulators, immunosuppressants, biologics, antibiotics, probiotics, and surgeries. A participant can receive more than one IDB therapy.
Duration of IBD Therapies	From 3 years prior to Day 1 until Day 1	Time between the beginning of IBD therapy until the end of treatment or Day 1, whichever comes first. IBD therapies include aminosalicylates, steroids, immunomodulators, immunosuppressants, biologics, antibiotics, probiotics, and surgeries.
Percentage of Participants With UC or CD Based on Biologic-experience	From 3 years prior to Day 1 until Day 1	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. Percentages are rounded off to the nearest single decimal.
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	Percentages are rounded off to the nearest single decimal.
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	Percentages are rounded off to the nearest single decimal.
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1	Day 1	The IBD treatment categories that have data for at least one participant are reported.
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	Day 1	CDAI assessed 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 indicate more severe disease. Socio-demographic variables included age, sex, professional status, educational level, participant income. Clinical variables included duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and EIM.
Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants	Day 1	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 were 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 included age, sex, professional status, educational level, participant income. Clinical variables included duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and extraintestinal manifestations (EIM).
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants	Day 1	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 were 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 component (physical component and mental component) was reported.
Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants	Day 1	The IBDQ was a 32-item questionnaire that measured 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the sum of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best. The sub-score ranged from 8 to 56 and thus the total score ranged from 32 to 224, where higher score indicating better quality of life.
Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants	The last 7 days prior to Day 1	WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 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 generated 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 were evaluated for this outcome measure. Mean total percentage of work impairment (absenteeism and presentisms) were reported in terms of hours.
Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants	The last 7 days prior to Day 1	WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 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 generated 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 were evaluated for this outcome measure. Mean work time missed (absenteeism) was reported.
Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants	The last 7 days prior to Day 1	WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 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 generated 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 were evaluated for this outcome measure. Mean impairment while working (presentisms) was reported.
Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants	The last 7 days prior to Day 1	WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 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 generated 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 only answered 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 was reported.
Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work	Day 1	Percentages are rounded off at the nearest single decimal.
Percentage of Participants With UC or CD Categorized Based on Healthcare Resources	From 3 years prior to Day 1 until Day 1	Healthcare resources included hospitalizations, medical appointments, imaging, and laboratory testing. Percentages are rounded off to whole number at the nearest decimal.
Total Direct Medical Cost for Participants With UC or CD	From 3 years prior to Day 1 until Day 1	A cost analysis of Ulcerative Colitis (UC) and Crohn's Disease (CD) was developed, classified by severity as mild and moderate-severe for each of the conditions. Direct medical costs were considered and included the following items: associated comorbidities, intestinal manifestations, surgical procedures, emergency visits, hospitalizations, medical appointments, follow-up studies, and previous pharmacological treatments; this was collected in the study including the number of participants and the proportion of them that presented the items studied. The total direct medical cost for all participants with each of the conditions was obtained, with the average 3-year cost per participant for UC and for CD multiplied by the number of all participants with UC and CD respectively. So, the values reported in the data table below represent the total direct cost for all participants with UC and CD respectively. The total direct cost was in Mexican Peso(MXN).
Indirect Cost for Participants With UC or CD	From 3 years prior to Day 1 until Day 1	A cost analysis of UC and CD was developed, classified by severity as mild and moderate-severe for each condition. Indirect cost was estimated by using number of hours missed from work (absenteeism) multiplied by average hourly labor cost including wages and benefits, to calculate average lost productivity cost per participant due to absenteeism during specified duration. Hours missed from work were assessed by Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answered 6 questions related to work productivity and impairment.The indirect medical cost for all participants with each of the conditions was obtained,with the average 3-year cost per participant for UC and for CD multiplied by the number of all employed participants with UC and CD respectively. So, values reported in data table below represent the indirect cost in totality for all employed participants with UC and CD respectively. The indirect cost is in MXN.

Trial Locations

Locations (12)

Unidad de Enfermedades Reumaticas y Cronico degenerativas; 🇲🇽 Torreon, Coahuila, Mexico

Centro De Investigacion Clinica De Alta Especialidad "Cicae"; 🇲🇽 Torreon, Coahuila, Mexico

Hospital Medica Sur Tlalpan; 🇲🇽 Ciudad de Mexico, Distrito Federal, Mexico

Instituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran; 🇲🇽 Ciudad de Mexico, Distrito Federal, Mexico

Endoamer S.C.; 🇲🇽 Guadalajara, Jalisco, Mexico

CIMESAP Sociedad de Responsabilidad Limitada de Capital Variable; 🇲🇽 Zapopan, Jalisco, Mexico

Fundacion Santos y de la Garza Evia; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Oncare Oncology; 🇲🇽 San Pedro Garza Garcia, Nuevo Leon, Mexico

Hospital Zambrano Hellion TecSalud; 🇲🇽 San Pedro Garza Garcia, Nuevo Leon, Mexico

Centro de Investigacion Clinica de Oaxaca; 🇲🇽 Oaxaca de Juarez, Oaxaca, Mexico

Torre Medica Sanatorio Toluca; 🇲🇽 Toluca, Mexico

Arke SMO S.A. De C.V; 🇲🇽 Veracruz, Mexico