An observational study in Inflammatory Bowel Diseases, Colitis, Ulcerative and Crohn Disease, sponsored by Takeda. Completed at 12 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Takeda · Observational
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.
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).
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 335 is above the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants diagnosed with moderate to severe UC or CD will be enrolled.
Exclusion Criteria:
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.
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.
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.
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.
Percentage of Participants With Active CD at 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.
Time frame: 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).
Time frame: Day 1
Number of Participants With CD Based on Clinical Presentation
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.
Time frame: Day 1
Number of Participants With UC Based on Clinical Presentation
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.
Time frame: 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, immunosuppressants, biologics, antibiotics, probiotics, and surgeries. A participant can receive more than one IDB therapy.
Time frame: 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, immunosuppressants, biologics, antibiotics, probiotics, and surgeries.
Time frame: 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. Percentages are rounded off to the nearest single decimal.
Time frame: 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
Percentages are rounded off to the nearest single decimal.
Time frame: 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
Percentages are rounded off to the nearest single decimal.
Time frame: From 3 years prior to Day 1 until Day 1
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1
The IBD treatment categories that have data for at least one participant are reported.
Time frame: 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 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.
Time frame: 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 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).
Time frame: 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 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.
Time frame: Day 1
Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants
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.
Time frame: Day 1
Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants
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.
Time frame: The last 7 days prior to Day 1
Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants
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.
Time frame: The last 7 days prior to Day 1
Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants
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.
Time frame: The last 7 days prior to Day 1
Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants
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.
Time frame: 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
Percentages are rounded off at the nearest single decimal.
Time frame: Day 1
Percentage of Participants With UC or CD Categorized Based on Healthcare Resources
Healthcare resources included hospitalizations, medical appointments, imaging, and laboratory testing. Percentages are rounded off to whole number at the nearest decimal.
Time frame: From 3 years prior to Day 1 until Day 1
Total Direct Medical Cost for Participants With UC or CD
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).
Time frame: From 3 years prior to Day 1 until Day 1
Indirect Cost for Participants With UC or CD
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.
Time frame: From 3 years prior to Day 1 until Day 1
Participants took part in the study at approximately 12 investigative sites in Mexico from 30 August 2021 to 17 May 2022.
| Milestone | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Started | 43 | 52 | 42 | 189 |
| Completed | 43 | 52 | 42 | 189 |
| Not completed | 0 | 0 | 0 | 0 |
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 | Crohn's Disease |
|---|---|
| Percentage of Participants With Active CD at Day 1 | 45.3 (35.3 to 55.3) |
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).
| percentage of participants | Ulcerative Colitis |
|---|---|
| Percentage of Participants With Active UC at Day 1 | 18.2 (13.2 to 23.2) |
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.
| Participants | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease |
|---|---|---|
| Location: Ileal(L1) | 0 | 9 |
| Location: L1+Isolated Upper GI Tract Disease(L4) | 0 | 1 |
| Location: Colonic Disease (L2) | 1 | 5 |
| Location: L2 + L4 | 1 | 0 |
| Location: Ileocolic(L3) | 4 | 11 |
| Behavior: Non stenosing/non penetrating | 0 | 10 |
| Behavior: Stenosing (B2) | 5 | 12 |
| Behavior: B2+Perianal Disease (P) | 0 | 2 |
| Behavior: Penetrating (B3) | 1 | 1 |
| Behavior: B3+P | 0 | 1 |
| Perianal Disease: None | 4 | 23 |
| Perianal Disease: Indolent Fistula | 0 | 3 |
| Perianal Disease: Active Fistula | 1 | 0 |
| Perianal Disease: Hemorrhoids | 1 | 0 |
| Ileal Disease: Achievement ≥1 | 3 | 19 |
| Ileal Disease: Achievement <1 | 3 | 3 |
| Extraintestinal Manifestations: Peripheral arthritis | 3 | 4 |
| Extraintestinal Manifestations: Aphthous ulcers | 0 | 2 |
| Extraintestinal Manifestations: Episcleritis | 0 | 1 |
| Extraintestinal Manifestations: Uveitis | 1 | 1 |
| Extraintestinal Manifestations: Osteoporosis | 0 | 1 |
| Extraintestinal Manifestations: Anemia | 2 | 0 |
| Extraintestinal Manifestations: Hematological alteration | 0 | 1 |
| Extraintestinal Manifestations: Other | 1 | 20 |
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.
| Participants | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|
| Location - Distal UC: Proctitis(E1) | 2 | 10 |
| Location - Distal UC: Proctosigmoiditis(E1) | 3 | 14 |
| Location - Left sided: Mucosa inflammation extending up to splenic flexure(E2) | 5 | 22 |
| Location - Pancolitis: Mucosa inflammation up to proximal transverse colon and beyond(E3) | 4 | 52 |
| Behavior - clinical remission (asymptomatic)(S0) | 0 | 43 |
| Behavior - mild UC(S1) | 5 | 34 |
| Behavior - moderate UC(S2) | 8 | 18 |
| Behavior - severe UC(S3) | 1 | 3 |
| Extraintestinal manifestations - Peripheral arthritis | 1 | 23 |
| Extraintestinal manifestations - Pyoderma gangrenosum | 0 | 2 |
| Extraintestinal manifestations - Aphthous ulcers | 0 | 1 |
| Extraintestinal manifestations - Primary sclerosing cholangitis | 0 | 1 |
| Extraintestinal manifestations - Osteoporosis | 0 | 2 |
| Extraintestinal manifestations - Anemia | 3 | 3 |
| Extraintestinal manifestations - Hematological alteration | 0 | 1 |
| Extraintestinal manifestations - Other | 10 | 70 |
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.
| Participants | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Sulfasalazine (SSZ) | 1 | 1 | 6 | 14 |
| Mesalazine (5-ASA) | 20 | 25 | 36 | 140 |
| Olsalazine | 0 | 0 | 1 | 1 |
| Mesalazine extended release | 2 | 3 | 5 | 52 |
| Hydrocortisone | 4 | 3 | 5 | 17 |
| Prednisone | 18 | 23 | 19 | 77 |
| Prednisolone | 0 | 0 | 2 | 3 |
| Budesonide | 5 | 9 | 7 | 42 |
| Methylprednisolone | 0 | 0 | 1 | 0 |
| Azathioprine | 14 | 19 | 12 | 81 |
| 6-mercaptopurine | 0 | 2 | 0 | 3 |
| Methotrexate | 4 | 3 | 1 | 0 |
| Infliximab | 13 | 9 | 9 | 46 |
| Adalimumab | 21 | 22 | 4 | 26 |
| Vedolizumab | 1 | 1 | 4 | 9 |
| Certolizumab | 4 | 1 | 0 | 0 |
| Golimumab | 0 | 0 | 2 | 3 |
| Ustekinumab | 13 | 8 | 2 | 1 |
| Metronidazole | 3 | 0 | 2 | 4 |
| Ciprofloxacin | 2 | 0 | 1 | 0 |
| Other | 14 | 3 | 11 | 44 |
| Salicylic derivatives + Immunosuppressants | 10 | 19 | 27 | 122 |
| Biologic therapy + Immunosuppressants | 12 | 14 | 1 | 4 |
| Salicylic derivatives + Immunosuppressants + Biologic therapy | 19 | 18 | 13 | 60 |
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.
| months | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Sulfasalazine (SSZ) | 0.2 (NA to NA) | — | 33.3 (17.0 to 42.0) | 62.3 (40.3 to 84.3) |
| Mesalazine (5-ASA) | 42.1 (3.7 to 111.1) | 34.3 (18.6 to 50.0) | 8.4 (0.2 to 347.2) | 54.3 (0.6 to 138.1) |
| Mesalazine Extended release | 31.0 (NA to NA) | — | — | — |
| Olsalazine | — | — | 60.0 (NA to NA) | — |
| Hydrocortisone | 0.1 (0.10 to 0.13) | 0.1 (NA to NA) | 0.2 (0.2 to 0.3) | 0.1 (0.0 to 0.3) |
| Prednisone | 5.0 (0.9 to 207.4) | 2.9 (1.1 to 83.9) | 1.6 (0.7 to 182.0) | 3.0 (0.1 to 148.5) |
| Prednisolone | — | — | — | 3.2 (NA to NA) |
| Budesonide | — | — | 2.0 (1.3 to 12.4) | 2.8 (1.4 to 18.0) |
| Azathioprine | 40.3 (2.7 to 111.1) | 38.6 (4.1 to 96.31) | 1.5 (0.06 to 153.5) | 45.5 (0.2 to 181.8) |
| Methotrexate | 4.9 (3.8 to 6.0) | — | 0.7 (NA to NA) | — |
| Metronidazole | 0.2 (NA to NA) | — | 0.2 (0.2 to 0.2) | 0.2 (0.2 to 0.3) |
| Ciprofloxacin | — | — | 0.2 (NA to NA) | — |
| Infliximab | 10.3 (0.8 to 17.0) | 62.3 (5.5 to 89.8) | 21.9 (3.1 to 73.4) | 14.2 (0.75 to 181.4) |
| Adalimumab | 27.5 (0.19 to 125.2) | 34.27 (5.3 to 103.8) | 28.6 (NA to NA) | 27.5 (0.1 to 125.2) |
| Vedolizumab | — | — | — | 9.0 (NA to NA) |
| Ustekimumab | 66.5 (50.4 to 82.6) | 1.0 (NA to NA) | — | — |
| Certolizumab | 15.7 (3.9 to 132.0) | — | — | — |
| Golimumab | — | — | 0.3 (NA to NA) | — |
| Other: | 23.8 (0.2 to 47.4) | — | 2.8 (0.1 to 128.2) | 4.5 (0.1 to 103.7) |
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 | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Percentage of Participants With UC or CD Based on Biologic-experience | 72.0 | 61.5 | 33.0 | 33.8 |
Percentages are rounded off to the nearest single decimal.
| percentage of participants | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies | 65.1 | 25.0 | 28.5 | 20.1 |
Percentages are rounded off to the nearest single decimal.
| percentage of participants | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Poor effectiveness | 34.8 | 15.3 | 11.9 | 9.5 |
| Patient decision | 6.9 | 0 | 0 | 0 |
| Remission | 0 | 0 | 0 | 1.0 |
| Unknown | 0 | 0 | 4.7 | 2.1 |
| Patient poor adherence | 2.3 | 3.8 | 0 | 1.0 |
| Comorbidity | 0 | 0 | 0 | 0.5 |
| Adverse reaction | 4.6 | 0 | 0 | 3.7 |
| Patient access to treatment | 6.9 | 0 | 0 | 0.5 |
| Antibodies | 2.3 | 1.9 | 0 | 0.5 |
| Serum level of antidrug | 0 | 1.9 | 0 | 0 |
| Other | 6.9 | 1.9 | 11.9 | 1.0 |
The IBD treatment categories that have data for at least one participant are reported.
| Participants | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Sulfasalazine (SSZ) | 0 | 1 | 0 | 2 |
| Mesalazine (5-ASA) | 0 | 0 | 1 | 2 |
| Mesalazine extended release | 0 | 0 | 0 | 2 |
| Prednisone | 0 | 1 | 2 | 2 |
| Budesonide | 0 | 1 | 0 | 3 |
| Azathioprine | 0 | 1 | 1 | 0 |
| Infliximab | 0 | 0 | 0 | 1 |
| Adalimumab | 1 | 0 | 0 | 0 |
| Vedolizumab | 1 | 1 | 0 | 0 |
| Ustekinumab | 0 | 1 | 0 | 0 |
| Metronidazole | 0 | 0 | 1 | 0 |
| Ciprofloxacin | 0 | 0 | 1 | 0 |
| Other | 1 | 0 | 1 | 2 |
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.
| Participants | Crohn's Disease |
|---|---|
| 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 | 43 |
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).
| Participants | Ulcerative Colitis |
|---|---|
| Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants | 42 |
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.
| score on a scale | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Physical Functioning | 64.2 ± 28.43 | 77.5 ± 24.10 | 71.1 ± 25.89 | 81.1 ± 22.97 |
| Bodily Pain | 52.7 ± 28.12 | 65.0 ± 27.90 | 57.5 ± 29.36 | 70.6 ± 26.09 |
| Role Physical | 55.5 ± 28.87 | 62.9 ± 28.29 | 51.8 ± 26.63 | 69.9 ± 25.43 |
| Role Emotional | 55.6 ± 28.51 | 62.2 ± 26.89 | 57.1 ± 28.07 | 70.6 ± 24.04 |
| Mental Health | 56.6 ± 20.43 | 60.9 ± 19.82 | 56.5 ± 22.62 | 64.8 ± 19.39 |
| Social Functioning | 53.8 ± 29.19 | 66.6 ± 25.09 | 59.2 ± 28.70 | 69.7 ± 26.81 |
| Vitality | 43.9 ± 20.30 | 53.7 ± 21.23 | 49.4 ± 22.55 | 57.2 ± 20.56 |
| General Health | 43.4 ± 20.64 | 48.0 ± 23.59 | 43.4 ± 22.26 | 53.6 ± 23.62 |
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.
| score on a scale | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants | 144.8 ± 42.78 | 159.03 ± 36.00 | 140.2 ± 43.67 | 165.7 ± 33.85 |
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.
| Percentage of total work impairment | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants | 20.337 ± 19.2252 | 21.184 ± 21.4860 | 24.152 ± 15.6386 | 17.700 ± 19.6796 |
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.
| percentage of work time missed | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants | 19.873 ± 30.6995 | 17.285 ± 25.1336 | 9.798 ± 16.3332 | 10.590 ± 23.7578 |
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.
| Percentage of Impairment | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants | 33.3 ± 33.85 | 30.0 ± 30.40 | 29.5 ± 22.69 | 23.1 ± 25.92 |
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 total activity impairment | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants | 45.7 ± 35.87 | 33.1 ± 30.76 | 44.0 ± 30.45 | 27.4 ± 29.53 |
Percentages are rounded off at the nearest single decimal.
| percentage of participants | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work | 0 | 0 | 4.8 | 0 |
Healthcare resources included hospitalizations, medical appointments, imaging, and laboratory testing. Percentages are rounded off to whole number at the nearest decimal.
| percentage of participants | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Hospital Admissions | 37.2 | 17.3 | 28.6 | 12.7 |
| Medical Appointments: IBD Specialist | 67.4 | 59.6 | 64.3 | 66.7 |
| Medical Appointments: Emergency Medical Appointment | 2.3 | 0 | 0 | 0 |
| Medical Appointments: Other Specialist | 4.7 | 0 | 2.4 | 4.2 |
| Imaging and Laboratory Testing | 60.5 | 61.5 | 52.4 | 67.2 |
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).
| MXN | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Total Direct Medical Cost for Participants With UC or CD | 16362506.13 | 12611636.50 | 9673667.75 | 33842289.53 |
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.
| MXN | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis |
|---|---|---|---|---|
| Indirect Cost for Participants With UC or CD | 394402.91 | 276419.13 | 77869.29 | 458451.24 |
Collected over Day 1. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate to Severe Crohn's Disease | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Mild to None Crohn's Disease | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Moderate to Severe Ulcerative Colitis | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Mild to None Ulcerative Colitis | 0/189 (0%) | 0/189 (0%) | 0/189 (0%) |
Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.
| Age, Continuous(years) | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis | Total |
|---|---|---|---|---|---|
| Mean | 49.5 (20 to 82) | 42.8 (21 to 81) | 43.0 (20 to 79) | 43.4 (18 to 80) | 44.67 (18 to 82) |
| Sex: Female, Male(Participants) | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis | Total |
|---|---|---|---|---|---|
| Female | 25 | 33 | 19 | 114 | 191 |
| Male | 18 | 19 | 23 | 75 | 135 |
| Race and Ethnicity Not Collected(Participants) | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Moderate to Severe Crohn's Disease | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis | Total |
|---|---|---|---|---|---|
| Mexico | 43 | 52 | 42 | 189 | 326 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Takeda