Inflammatory Bowel Disease
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to gather information regarding the population with moderate to severe inflammatory bowel disease (IBD), the burden of the disease, and understand their treatment patterns, particularly on the use of available biologic therapies.
Detailed description
This is a non-interventional study to determine the rate of control of disease activity in moderate to severe inflammatory bowel disease (IBD) participants, with two parts: cross-sectional evaluation (Day 1) with retrospective data collection and a prospective 12-month evaluation for patients with active IBD at cross-sectional evaluation (Day 1). The study enrolled 407 patients. This multicenter trial was conducted in Brazil. Retrospective data of previous IBD treatments (drug, dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years will be collected. Prospective data was collected for a period of 12 months in participants with active disease. UC participants, with no or light disease activity at Day 1 did not continue to 12-month follow up. CD participants, with no or light disease activity at Day 1 but with colonoscopy or calprotectin levels (i.e, calprotectin \>200 ug/g) in the previous year suggestive of inadequate control of activity progressed to 12-month follow up.
Interventions
OTHERNo Intervention
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female. 2. 18 years or older (at the time of diagnosis of moderate to severe UC or CD). 3. Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment according the clinical or endoscopic \\ criteria. 4. Has provided the written informed consent. For the prospective period, eligible participants should present at least one of the following criteria that will only be applied at Day 1: 5. For CD participants: * Harvey Bradshaw Index (HBI) ≥8 or * Crohn's Disease Activity Index (CDAI) ≥220 or Considering that for CD participants, the disease activity may not be clearly documented only with clinical data, some objective criteria may be considered as entry criteria for the 12-month prospective period: * Colonoscopy in the previous year suggestive of inadequate control of activity or, * Calprotectin levels in the previous year suggestive of inadequate control of activity (i.e, calprotectin \>200 µg/g). 6. For UC: partial Mayo Score ≥5. Note: Participants with colostomy and prospective period: Although clinical scales defined above are impacted by colostomy these participants will not be excluded from the protocol to ensure the assessment of different clinical presentations of the IBD. In addition, participants with colostomy must follow the same criteria as above to be eligible to the prospective phase.
Exclusion criteria
1. Indeterminate or not classified colitis. 2. Current or previous participation in interventional clinical trial (within the last 3 years). In addition, for the 12-month prospective period, participants will be excluded if: 3. Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 4. Hospitalized participants at Day 1. 5. Current off label treatment with Vedolizumab. Study Discontinuation Criteria It will be considered a premature termination the situation in which the participant discontinues the participation, i.e. they are withdrawn from the study before completing the 12 months of follow up period (365 days ± 14 days from Day 1), due to any of the reasons listed below: 1. Withdrawal of consent: participants who for any reason withdraw the free and informed consent; 2. Lost to follow-up (no return of the participant on the expected date of visit - drop-out from the protocol); 3. Death; 4. Study termination; 5. Any situation that places the participant within one of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Active Crohn's Disease (CD) at Day 1 | Day 1 | Participants with Harvey Bradshaw Index (HBI) score of ≥8 or Crohn´s Disease Activity Index (CDAI) ≥220 points at Day 1 were classified as participants with active disease. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. The CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity. |
| Number of Participants With Active Ulcerative Colitis (UC) at Day 1 | Day 1 | Participants with ≥5 points in Partial Mayo Score were classified as active UC disease. The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Within the previous 3 years including Day 1 | Therapies for IBD included aminosalicylates, steroids, immunossupressors, biologics, antibiotics, surgeries and others. One participant could use more than one therapy. |
| Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Within the previous 3 years including Day 1 | IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab. One participant could use more than one biologic therapy. |
| Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies | Day 1 | IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab. |
| Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1 | Day 1 | Participants with moderate to severe CD or UC ongoing IBD treatment at Day 1 were reported. |
| Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Day 1 | Socio-demographic variables included gender and professional status. |
| Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Day 1 | Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Steroid behavior; Colonoscopy, Calprotectin levels \>200ug/g. |
| Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Day 1 | Treatment variables included previous treatments or regimens (aminosalicylates, steroids, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens. |
| Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Day 1 | Socio-demographic variables included gender and professional status. |
| Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Day 1 | Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels \>200ug/g. |
| Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Day 1 | Treatment variables include previous treatments or regimens (aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens. |
| Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12 | Day 1 and Month 12 | HBI scale assessed the severity of CD. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. Higher score indicates higher disease activity. |
| Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Day 1 | — |
| Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12 | Day 1 and Month 12 | The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). |
| Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Month 12 | One participant could have more than one reason for discontinuation. |
| Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1 | Day 1 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. |
| Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1 | Day 1 | The Short Form-36 (SF-36) is a questionnaire that evaluates a participant's health related quality of life. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1 | Day 1 | The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 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 total score ranged from 32 to 224, with higher scores representing better quality of life. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Day 1 | The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 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 average of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best function. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants. |
| Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1 | Day 1 | The Work Productivity and Activity Impairment questionnaire (WPAI) assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The 'impairment while working due to IBD' was calculated based on one question: to what degree did the disease impair the productivity while working in the past seven days from visit and the 'activity impairment' was calculated based on Question: how much did the disease affect ability to perform regular daily activities, other than work at a job? Percentage of overall work impairment due to IBD is calculated as: Absenteeism+(1-Absenteeism)\*Presenteeism. The total score ranges from 0 (no impairment) to 100% (total loss of work productivity). |
| Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1 | Day 1 | Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity. |
| Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1 | Day 1 | Mean impairment while working due to IBD from WPAI questionnaire was reported. The 'impairment while working due to IBD' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. ata are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity. |
| Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI | Day 1 | Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity. |
| Percentage of Participants Who Used Healthcare Resources | Day 1 | Healthcare resources used in the previous 3 years included imaging and laboratory testing, surgeries, hospitalizations, and consultations. |
| Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12 | Day 1 and Month 12 | CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity. |
| Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Day 1 | Clinical variables included IBD type:CD/UC; anthropometric (Height, Weight and BMI); Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels \>200ug/g, Eligibility for 12-month follow-up. |
Countries
Brazil
Participant flow
Recruitment details
Participants took part in the study at the 14 investigative sites in Brazil from 11 October 2016 to 19 Feb 2018.
Pre-assignment details
Participants diagnosed with infectious bowel disease (IBD)- Crohn's disease (CD) or ulcerative colitis (UC) were observed to collect the retrospective data on Day 1. Participants with active disease at Day 1 entered Prospective phase and were followed up for a period of 12 months.
Participants by arm
| Arm | Count |
|---|---|
| Crohn's Disease Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase. | 264 |
| Ulcerative Colitis Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase. | 143 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Cross-sectional Phase (Day 1) | Not Eligible for Prospective Follow-up | 144 | 107 |
| Cross-sectional Phase (Day 1) | Reason Not Specified | 2 | 0 |
| Prospective Phase (Day 1 up to Month 12) | Death | 1 | 0 |
| Prospective Phase (Day 1 up to Month 12) | Lost to Follow-up | 4 | 0 |
| Prospective Phase (Day 1 up to Month 12) | Reason Not Specified | 6 | 1 |
| Prospective Phase (Day 1 up to Month 12) | Withdrawal of Consent | 0 | 1 |
Baseline characteristics
| Characteristic | Crohn's Disease | Ulcerative Colitis | Total |
|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 12.96 | 45.9 years STANDARD_DEVIATION 13.83 | 43.9 years STANDARD_DEVIATION 13.34 |
| (Body Mass Index) BMI | 25.1 kg/m^2 STANDARD_DEVIATION 4.67 | 25.7 kg/m^2 STANDARD_DEVIATION 4.63 | 25.3 kg/m^2 STANDARD_DEVIATION 4.66 |
| Educational Level Higher Education | 46 Participants | 14 Participants | 60 Participants |
| Educational Level Higher Education Not Completed | 18 Participants | 8 Participants | 26 Participants |
| Educational Level Not Literate | 3 Participants | 0 Participants | 3 Participants |
| Educational Level Post-graduate/Master of Business Administration | 5 Participants | 1 Participants | 6 Participants |
| Educational Level Primary School | 26 Participants | 11 Participants | 37 Participants |
| Educational Level Primary School Not Completed | 26 Participants | 27 Participants | 53 Participants |
| Educational Level Secondary School | 74 Participants | 33 Participants | 107 Participants |
| Educational Level Secondary School Not Completed | 9 Participants | 4 Participants | 13 Participants |
| Educational Level Unknown | 57 Participants | 45 Participants | 102 Participants |
| Height | 166.0 cm STANDARD_DEVIATION 9.89 | 165.1 cm STANDARD_DEVIATION 10.7 | 165.7 cm STANDARD_DEVIATION 10.18 |
| Income >10-20 MS (R$ 8.800,01- R$ 17.600,00) | 5 Participants | 2 Participants | 7 Participants |
| Income >1/2-1 MS (R$ 440,01 - R$ 880,00) | 18 Participants | 7 Participants | 25 Participants |
| Income >1-2 MS (R$ 880,01 - R$ 1.760,00) | 49 Participants | 16 Participants | 65 Participants |
| Income ≤1/2 MS (Until R$ 440,00 (Including)) | 1 Participants | 1 Participants | 2 Participants |
| Income >2-3 MS (R$ 1.760,01 - R$ 2.640,00) | 25 Participants | 12 Participants | 37 Participants |
| Income >3-5 MS (R$ 2.640,01 - R$ 4.440,00) | 28 Participants | 10 Participants | 38 Participants |
| Income > 5-10 MS (R$ 4.400,01 - R$ 8.800,00) | 8 Participants | 7 Participants | 15 Participants |
| Income No Income | 25 Participants | 14 Participants | 39 Participants |
| Income Unknown/Not Informed | 105 Participants | 74 Participants | 179 Participants |
| Professional Situation Employed | 101 Participants | 53 Participants | 154 Participants |
| Professional Situation Other | 26 Participants | 18 Participants | 44 Participants |
| Professional Situation Retired | 30 Participants | 15 Participants | 45 Participants |
| Professional Situation Student | 10 Participants | 5 Participants | 15 Participants |
| Professional Situation Unemployed | 61 Participants | 33 Participants | 94 Participants |
| Professional Situation Unknown | 36 Participants | 19 Participants | 55 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Brazil | 264 Participants | 143 Participants | 407 Participants |
| Sex: Female, Male Female | 143 Participants | 81 Participants | 224 Participants |
| Sex: Female, Male Male | 121 Participants | 62 Participants | 183 Participants |
| Smoking Status Current Smoker | 24 Participants | 3 Participants | 27 Participants |
| Smoking Status Former Smoker | 47 Participants | 38 Participants | 85 Participants |
| Smoking Status Never Smoked | 171 Participants | 91 Participants | 262 Participants |
| Smoking Status Unknown | 22 Participants | 11 Participants | 33 Participants |
| Weight | 69.0 kg STANDARD_DEVIATION 14.52 | 70.1 kg STANDARD_DEVIATION 14.33 | 69.4 kg STANDARD_DEVIATION 14.45 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 264 | 0 / 143 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Active Ulcerative Colitis (UC) at Day 1
Participants with ≥5 points in Partial Mayo Score were classified as active UC disease. The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease).
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Participants with UC from cross-sectional population were analyzed for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Number of Participants With Active Ulcerative Colitis (UC) at Day 1 | 36 participants |
Primary
Percentage of Participants With Active Crohn's Disease (CD) at Day 1
Participants with Harvey Bradshaw Index (HBI) score of ≥8 or Crohn´s Disease Activity Index (CDAI) ≥220 points at Day 1 were classified as participants with active disease. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. The CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Participants with CD from cross-sectional population were analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants With Active Crohn's Disease (CD) at Day 1 | HBI Score ≥8 | 16.52 percentage of participants |
| Crohn's Disease | Percentage of Participants With Active Crohn's Disease (CD) at Day 1 | CDAI Score ≥220 | 25.97 percentage of participants |
Secondary
Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12
CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.
Time frame: Day 1 and Month 12
Population: Longitudinal population included all participants who were eligible for the prospective period. Participants with active CD with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12 | Month 12 | 122.0 score on a scale | Standard Deviation 68.82 |
| Crohn's Disease | Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12 | Day 1 | 197.3 score on a scale | Standard Deviation 124.44 |
Secondary
Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12
HBI scale assessed the severity of CD. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. Higher score indicates higher disease activity.
Time frame: Day 1 and Month 12
Population: Longitudinal population included all participants who were eligible for the prospective period. Participants with active CD with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12 | Day 1 | 7.2 score on a scale | Standard Deviation 8.53 |
| Crohn's Disease | Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12 | Month 12 | 3.7 score on a scale | Standard Deviation 3.68 |
Secondary
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1
The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 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 average of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best function. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Bowel Systems | 5.4 score on a scale | Standard Deviation 1.24 |
| Crohn's Disease | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Systemic Systems | 4.6 score on a scale | Standard Deviation 1.48 |
| Crohn's Disease | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Social Function | 5.2 score on a scale | Standard Deviation 1.58 |
| Crohn's Disease | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Emotional Health | 4.7 score on a scale | Standard Deviation 1.46 |
| Ulcerative Colitis | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Emotional Health | 4.6 score on a scale | Standard Deviation 1.64 |
| Ulcerative Colitis | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Bowel Systems | 5.1 score on a scale | Standard Deviation 1.63 |
| Ulcerative Colitis | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Social Function | 5.0 score on a scale | Standard Deviation 1.81 |
| Ulcerative Colitis | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 | Systemic Systems | 4.5 score on a scale | Standard Deviation 1.64 |
Secondary
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1
The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 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 total score ranged from 32 to 224, with higher scores representing better quality of life. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1 | 158.9 score on a scale | Standard Deviation 41.41 |
| Ulcerative Colitis | Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1 | 153.2 score on a scale | Standard Deviation 49.66 |
Secondary
Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1
Mean impairment while working due to IBD from WPAI questionnaire was reported. The 'impairment while working due to IBD' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. ata are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1 | 24.4 percentage of impairment while working | Standard Deviation 27.94 |
| Ulcerative Colitis | Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1 | 17.5 percentage of impairment while working | Standard Deviation 26 |
Secondary
Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI
Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI | 35.8 percentage of total activity impairment | Standard Deviation 33.49 |
| Ulcerative Colitis | Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI | 39.9 percentage of total activity impairment | Standard Deviation 37.45 |
Secondary
Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1
The Work Productivity and Activity Impairment questionnaire (WPAI) assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The 'impairment while working due to IBD' was calculated based on one question: to what degree did the disease impair the productivity while working in the past seven days from visit and the 'activity impairment' was calculated based on Question: how much did the disease affect ability to perform regular daily activities, other than work at a job? Percentage of overall work impairment due to IBD is calculated as: Absenteeism+(1-Absenteeism)\*Presenteeism. The total score ranges from 0 (no impairment) to 100% (total loss of work productivity).
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1 | Percentage of Total Work Productivity Impairment | 32.3 percentage of total work impairment | Standard Deviation 32.97 |
| Crohn's Disease | Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1 | Percentage of Total Activity Impairment | 35.8 percentage of total work impairment | Standard Deviation 33.49 |
| Ulcerative Colitis | Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1 | Percentage of Total Work Productivity Impairment | 25.3 percentage of total work impairment | Standard Deviation 33.13 |
| Ulcerative Colitis | Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1 | Percentage of Total Activity Impairment | 39.9 percentage of total work impairment | Standard Deviation 37.45 |
Secondary
Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1
Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1 | 12.6 percentage of work time missed | Standard Deviation 23.78 |
| Ulcerative Colitis | Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1 | 11.7 percentage of work time missed | Standard Deviation 26.69 |
Secondary
Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables
Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Steroid behavior; Colonoscopy, Calprotectin levels \>200ug/g.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Calprotectin >200ug/g | 41 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Never Smoked | 84 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Former Smoker | 15 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Current smoker | 7 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L1 | 22 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L2 | 21 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L3+L4 | 1 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B1 | 26 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B1+P | 5 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B2 | 39 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B2+P | 13 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B3 | 11 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B3+P | 24 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Steroid Behavior, Steroid-dependent | 17 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Family History of IBD | 15 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Medical History, Comorbidity or EIM | 66 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L1+L4 | 4 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L3 | 70 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, P | 0 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Steroid Behavior, Steroid-refractory disease | 5 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Colonoscopy | 104 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B2+P | 18 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L1 | 39 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Never Smoked | 87 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B3 | 23 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Former Smoker | 32 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Steroid Behavior, Steroid-dependent | 14 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Current smoker | 17 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, P | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L1+L4 | 2 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Family History of IBD | 18 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L2 | 21 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L3 | 74 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Colonoscopy | 107 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Location of CD, L3+L4 | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Calprotectin >200ug/g | 38 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B1 | 20 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B3+P | 33 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B1+P | 7 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Steroid Behavior, Steroid-refractory disease | 11 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Behavior, B2 | 40 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables | Medical History, Comorbidity or EIM | 77 Participants |
Secondary
Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables
Socio-demographic variables included gender and professional status.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Unknown | 20 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Retired | 13 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Gender, Male | 49 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Student | 2 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Gender, Female | 69 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Other | 16 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Employed | 36 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Unemployed | 31 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Unemployed | 30 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Student | 8 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Retired | 17 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Other | 10 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Unknown | 16 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Gender, Male | 72 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Gender, Female | 74 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Employed | 65 Participants |
Secondary
Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables
Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels \>200ug/g.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Former Smoker | 9 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Smoking status, Current smoker | 0 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Extent Inflammation, E1-Distal: Proctitis | 5 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Extent of Inflammation, E2-Left-sided | 8 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Extent of Inflammation, E3-Pancolitis | 18 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Severity, S0-Clinical Remission | 0 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Severity, S1-Mild UC | 3 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Severity, S2-Moderate UC | 25 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Severity, S3-Severe UC | 8 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Steroid Behavior, Steroid-dependent | 10 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Steroid Behavior, Steroid-refractory disease | 3 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Family History of IBD | 2 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Never Smoked | 25 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Medical History, Comorbidity or EIM | 20 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Extent Inflammation, E1-Distal: Proctosigmoiditis | 5 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Colonoscopy | 29 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Colonoscopy | 87 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Former Smoker | 29 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Extent Inflammation, E1-Distal: Proctosigmoiditis | 21 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Smoking status, Current smoker | 3 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Medical History, Comorbidity or EIM | 59 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Steroid Behavior, Steroid-refractory disease | 8 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Extent of Inflammation, E2-Left-sided | 18 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Family History of IBD | 13 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Extent of Inflammation, E3-Pancolitis | 56 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Severity, S2-Moderate UC | 15 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Severity, S0-Clinical Remission | 57 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Smoking Status, Never Smoked | 66 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Severity, S1-Mild UC | 29 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Steroid Behavior, Steroid-dependent | 13 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Extent Inflammation, E1-Distal: Proctitis | 12 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables | Severity, S3-Severe UC | 6 Participants |
Secondary
Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables
Socio-demographic variables included gender and professional status.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Unemployed | 8 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Unknown | 5 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Retired | 6 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Gender, Male | 10 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Student | 3 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Gender, Female | 26 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Other | 9 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Employed | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Other | 9 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Unemployed | 25 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Student | 2 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Retired | 9 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Employed | 48 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Professional Status, Unknown | 14 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Gender, Male | 52 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables | Gender, Female | 55 Participants |
Secondary
Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1
Time frame: Day 1
Population: Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Age ≥18-39 years old | 52 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Age ≥40-59 years old | 49 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Age ≥ 60 years old | 17 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Not Literate | 1 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Primary School Not Completed | 16 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Secondary School | 34 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Secondary School Not Completed | 3 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Higher Education | 23 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Higher Education Not Completed | 6 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >3-5 MS (R$ 2.640,01 - R$ 4.440,00) | 13 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >2-3 MS (R$ 1.760,01 - R$ 2.640,00) | 10 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, Unknown | 31 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, Not Informed | 20 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Gender, Male | 49 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Gender, Female | 69 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Employed | 36 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Unemployed | 31 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Student | 2 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Retired | 13 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Other | 16 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Unknown | 20 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Family History of IBD | 15 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Primary School | 7 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Post-Graduate/MBA | 3 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Unknown | 25 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >10-20 MS (R$ 8.800,01 - R$ 17.600,00) | 3 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >5-10 MS (R$ 4.400,01 - R$ 8.800,00) | 1 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >1-2 MS (R$ 880,01 - R$ 1.760,00) | 19 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >½-1 MS (R$ 440,01 - R$ 880,00) | 10 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, ≤½ MS (Until R$ 440,00 (Including)) | 1 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, No Income | 10 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Employed | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Age ≥18-39 years old | 15 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Post-Graduate/MBA | 0 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Age ≥40-59 years old | 15 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Unemployed | 8 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Family History of IBD | 2 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >1-2 MS (R$ 880,01 - R$ 1.760,00) | 2 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Primary School | 3 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Student | 3 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Primary School Not Completed | 6 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Unknown | 15 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Secondary School | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Retired | 6 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Secondary School Not Completed | 2 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, ≤½ MS (Until R$ 440,00 (Including)) | 0 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Higher Education | 2 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Other | 9 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >5-10 MS (R$ 4.400,01 - R$ 8.800,00) | 1 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >10-20 MS (R$ 8.800,01 - R$ 17.600,00) | 1 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >3-5 MS (R$ 2.640,01 - R$ 4.440,00) | 1 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Professional Status, Unknown | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, No Income | 6 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >½-1 MS (R$ 440,01 - R$ 880,00) | 2 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, Unknown | 10 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Not Literate | 0 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Age ≥ 60 years old | 6 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, >2-3 MS (R$ 1.760,01 - R$ 2.640,00) | 1 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Gender, Male | 10 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Educational Level, Higher Education Not Completed | 3 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Gender, Female | 26 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1 | Income, Not Informed | 12 Participants |
Secondary
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables
Clinical variables included IBD type:CD/UC; anthropometric (Height, Weight and BMI); Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels \>200ug/g, Eligibility for 12-month follow-up.
Time frame: Day 1
Population: Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | BMI - <24 Kg/m^2 | 54 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | BMI - 25 - 30 Kg/m^2 | 43 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Family History of IBD | 15 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Medical History, Comorbidity or EIM | 66 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Location of CD, L1 | 22 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Location of CD, L1+L4 | 4 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Location of CD, L2 | 21 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Location of CD, L3 | 70 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Behavior, B1 | 26 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Behavior, B1+P | 5 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Behavior, B2 | 39 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Behavior, B2+P | 13 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Behavior, B3 | 11 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Behavior, B3+P | 24 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Location of CD, L3+L4 | 1 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Weight (kg) | NA Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Steroid Behavior, Steroid-dependent | 17 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Smoking Status, Never Smoked | 84 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Steroid Behavior, Steroid-refractory Disease | 5 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Colonoscopy | 104 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Calprotectin >200ug/g | 13 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Height (cm) | NA Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | BMI - ≥30 Kg/m^2 | 13 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | CD or UC, Moderate to Severe Activity | 118 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Smoking Status, Former Smoker | 15 Participants |
| Crohn's Disease | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Smoking Status, Current smoker | 7 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Colonoscopy | 29 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Height (cm) | NA Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | BMI - 25 - 30 Kg/m^2 | 7 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | BMI - ≥30 Kg/m^2 | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Family History of IBD | 2 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Smoking Status, Never Smoked | 25 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Smoking Status, Current smoker | 0 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Severity, S1-Mild UC | 3 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Steroid Behavior, Steroid-dependent | 10 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Calprotectin >200ug/g | NA Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | CD or UC, Moderate to Severe Activity | 36 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Weight (kg) | NA Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | BMI - <24 Kg/m^2 | 23 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Smoking Status, Former Smoker | 9 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Medical History, Comorbidity or EIM | 20 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Extent Inflammation, E1-Distal: Proctitis | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Extent Inflammation, E1-Distal: Proctosigmoiditis | 5 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Extent of Inflammation, E2-Left-sided | 8 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Extent of Inflammation, E3-Pancolitis | 18 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Severity, S2-Moderate UC | 25 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Severity, S3-Severe UC | 8 Participants |
| Ulcerative Colitis | Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables | Steroid Behavior, Steroid-refractory Disease | 3 Participants |
Secondary
Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12
The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease).
Time frame: Day 1 and Month 12
Population: Longitudinal population included all participants who were eligible for the prospective period. Participants with active UC with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12 | Day 1 | 5.4 score on a scale | Standard Deviation 0.52 |
| Crohn's Disease | Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12 | Month 12 | 2.3 score on a scale | Standard Deviation 2.16 |
Secondary
Percentage of Participants Who Used Healthcare Resources
Healthcare resources used in the previous 3 years included imaging and laboratory testing, surgeries, hospitalizations, and consultations.
Time frame: Day 1
Population: Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants Who Used Healthcare Resources | Previous Surgery for IBD | 27.1 percentage of participants |
| Crohn's Disease | Percentage of Participants Who Used Healthcare Resources | Previous Imaging and Laboratory Testing Due to IBD | 98.3 percentage of participants |
| Crohn's Disease | Percentage of Participants Who Used Healthcare Resources | Previous Hospitalization Due to IBD | 43.2 percentage of participants |
| Crohn's Disease | Percentage of Participants Who Used Healthcare Resources | Previous Medical Appointments Due to IBD | 99.2 percentage of participants |
| Ulcerative Colitis | Percentage of Participants Who Used Healthcare Resources | Previous Hospitalization Due to IBD | 30.6 percentage of participants |
| Ulcerative Colitis | Percentage of Participants Who Used Healthcare Resources | Previous Surgery for IBD | 2.8 percentage of participants |
| Ulcerative Colitis | Percentage of Participants Who Used Healthcare Resources | Previous Medical Appointments Due to IBD | 100.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants Who Used Healthcare Resources | Previous Imaging and Laboratory Testing Due to IBD | 100.0 percentage of participants |
Secondary
Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason
One participant could have more than one reason for discontinuation.
Time frame: Month 12
Population: Longitudinal population included all participants who were eligible for the prospective period (participants with active IBD at Day 1).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Patient access to the treatment | 0.7 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Comorbidity | 0.4 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Patient poor adherence | 3.2 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Contraindication | 0.0 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Other | 25.1 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Pregnancy | 0.4 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Weight change | 0.4 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Poor Effectiveness | 10.6 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Unknown | 38.9 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Remission | 11.0 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Adverse Reaction | 7.1 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Patient decision | 1.8 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Surgery | 0.7 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Unknown | 46.3 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Surgery | 0.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Weight change | 0.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Patient decision | 5.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Patient poor adherence | 1.3 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Patient access to the treatment | 0.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Other | 2.5 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Adverse Reaction | 3.8 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Comorbidity | 0.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Contraindication | 1.3 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Pregnancy | 3.2 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Poor Effectiveness | 12.4 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason | Remission | 27.5 percentage of participants |
Secondary
Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years
IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab. One participant could use more than one biologic therapy.
Time frame: Within the previous 3 years including Day 1
Population: Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Adalimumab | 30.5 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Certolizumab | 0.8 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Vedolizumab | 2.5 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Ustekimumab | 0.8 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Infliximab | 33.1 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Ustekimumab | 0.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Infliximab | 16.7 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Adalimumab | 11.1 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Vedolizumab | 5.6 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years | Certolizumab | 0.0 percentage of participants |
Secondary
Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies
IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab.
Time frame: Day 1
Population: Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies | 36.4 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies | 33.3 percentage of participants |
Secondary
Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years
Therapies for IBD included aminosalicylates, steroids, immunossupressors, biologics, antibiotics, surgeries and others. One participant could use more than one therapy.
Time frame: Within the previous 3 years including Day 1
Population: Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Surgeries | 27.1 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Others | 5.9 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Salycyclic Derivates | 16.9 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Corticosteroids | 14.4 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Immunosuppresors | 67.8 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Biologic Therapy | 66.9 percentage of participants |
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Antibiotics | 9.3 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Surgeries | 2.8 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Immunosuppresors | 47.2 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Others | 16.7 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Antibiotics | 13.9 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Salycyclic Derivates | 75.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Biologic Therapy | 30.6 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years | Corticosteroids | 36.1 percentage of participants |
Secondary
Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1
Participants with moderate to severe CD or UC ongoing IBD treatment at Day 1 were reported.
Time frame: Day 1
Population: Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1 | 94.1 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1 | 88.9 percentage of participants |
Secondary
Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables
Treatment variables included previous treatments or regimens (aminosalicylates, steroids, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Corticosteroids | 17 Participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Biologic Therapy | 79 Participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Antibiotics | 11 Participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Other | 7 Participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Salicylic Derivates | 20 Participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Immunosuppressors | 80 Participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Previous Surgery | 32 Participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Other | 6 Participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Corticosteroids | 13 Participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Immunosuppressors | 98 Participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Salicylic Derivates | 19 Participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Biologic Therapy | 110 Participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Previous Surgery | 35 Participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Antibiotics | 3 Participants |
Secondary
Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables
Treatment variables include previous treatments or regimens (aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Immunosuppressors | 47.2 percentage of participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Biologic Therapy | 30.6 percentage of participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Corticosteroids | 36.1 percentage of participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Antibiotics | 13.9 percentage of participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Other | 16.7 percentage of participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Previous Surgery | 2.8 percentage of participants |
| Crohn's Disease | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Salicylic Derivates | 75.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Previous Surgery | 2.8 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Corticosteroids | 12.1 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Antibiotics | 1.9 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Immunosuppressors | 43.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Biologic Therapy | 28.0 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Other | 7.9 percentage of participants |
| Ulcerative Colitis | Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables | Type of Therapy, Salicylic Derivates | 68.2 percentage of participants |
Secondary
Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1
The Short Form-36 (SF-36) is a questionnaire that evaluates a participant's health related quality of life. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1 | Mental Component Score | 42.6 score on a scale | Standard Deviation 12 |
| Crohn's Disease | Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1 | Physical Component Score | 43.3 score on a scale | Standard Deviation 10.15 |
| Ulcerative Colitis | Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1 | Mental Component Score | 36.4 score on a scale | Standard Deviation 13.48 |
| Ulcerative Colitis | Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1 | Physical Component Score | 40.8 score on a scale | Standard Deviation 9.13 |
Secondary
Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants.
Time frame: Day 1
Population: Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1 | 68.9 score on a scale | Standard Deviation 22.14 |
| Ulcerative Colitis | Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1 | 55.2 score on a scale | Standard Deviation 22.44 |