Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02822235
• Collaborator: (none)
• Enrollment: 407
• Locations: 13
• Actual Duration (Months): 16.3
• Patients Per Site: 31.3
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease	Other: No Intervention

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 407 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Real-world Data of Moderate to Severe Inflammatory Bowel Disease in Brazil: a Non-interventional, Multicenter Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life (RISE BR)
• Actual Study Start Date: Oct 11, 2016
• Actual Primary Completion Date: Feb 5, 2018
• Actual Study Completion Date: Feb 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Crohn's Disease Participants with diagnosis of moderate to severe Crohn's disease (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 IBD and CD at Day 1 were followed up for 12 months in prospective phase.	Other: No Intervention
Ulcerative Colitis Participants diagnosed with diagnosis of moderate to severe ulcerative colitis (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 IBD and UC at Day 1 were followed up for 12 months in prospective phase.	Other: No Intervention

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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]

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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).

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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).

22. 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.

23. 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.

24. 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.

25. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

1. 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 exclusion criteria.

Note: Participants who are eligible for the prospective period, it means, with active disease at Day 1 but who during the 12 months period presents disease remission and/or no activity disease condition, are allowed to continue the participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Salvador	Bahia	Brazil
2		Goiania	Goias	Brazil
3		Belo Horizonte	Minas Gerais	Brazil
4		Juiz de Fora	Minas Gerais	Brazil
5		Curitiba	Parana	Brazil
6		Teresina	Piaui	Brazil
7		Porto Alegre	Rio Grande Do Sul	Brazil
8		Botucatu	Sao Paulo	Brazil
9		Ribeirao Preto	Sao Paulo	Brazil
10		Santo Andre	Sao Paulo	Brazil
11		Sao Jose do Rio Preto	Sao Paulo	Brazil
12		Rio de Janeiro		Brazil
13		Sao Paulo		Brazil

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Abner Augusto Lobão Neto Clinical Science, Takeda

Study Documents (Full-Text)

• Study Protocol - Oct 17, 2016
• Statistical Analysis Plan - Jan 30, 2018

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02822235
• Other Study ID Numbers: Vedolizumab-4008; U1111-1178-66445
• First Posted: Jul 4, 2016
• Last Update Posted: Feb 25, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Takeda: Drug Therapy
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases

Study Results

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 Detail	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.

Arm/Group Title	Crohn's Disease	Ulcerative Colitis
Arm/Group Description	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.	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.
Period Title: Cross-sectional Phase (Day 1)
STARTED	264	143
COMPLETED	118	36
NOT COMPLETED	146	107
Period Title: Cross-sectional Phase (Day 1)
STARTED	118	36
COMPLETED	107	34
NOT COMPLETED	11	2

Baseline Characteristics

Arm/Group Title	Crohn's Disease	Ulcerative Colitis	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	264	143	407
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.9 (12.96)	45.9 (13.83)	43.9 (13.34)
Sex: Female, Male (Count of Participants)
Female	143 54.2%	81 56.6%	224 55%
Male	121 45.8%	62 43.4%	183 45%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Brazil	264 100%	143 100%	407 100%
Professional Situation (Count of Participants)
Employed	101 38.3%	53 37.1%	154 37.8%
Unemployed	61 23.1%	33 23.1%	94 23.1%
Student	10 3.8%	5 3.5%	15 3.7%
Retired	30 11.4%	15 10.5%	45 11.1%
Other	26 9.8%	18 12.6%	44 10.8%
Unknown	36 13.6%	19 13.3%	55 13.5%
Educational Level (Count of Participants)
Not Literate	3 1.1%	0 0%	3 0.7%
Primary School	26 9.8%	11 7.7%	37 9.1%
Primary School Not Completed	26 9.8%	27 18.9%	53 13%
Secondary School	74 28%	33 23.1%	107 26.3%
Secondary School Not Completed	9 3.4%	4 2.8%	13 3.2%
Higher Education	46 17.4%	14 9.8%	60 14.7%
Higher Education Not Completed	18 6.8%	8 5.6%	26 6.4%
Post-graduate/Master of Business Administration	5 1.9%	1 0.7%	6 1.5%
Unknown	57 21.6%	45 31.5%	102 25.1%
Income (Count of Participants)
>10-20 MS (R$ 8.800,01- R$ 17.600,00)	5 1.9%	2 1.4%	7 1.7%
> 5-10 MS (R$ 4.400,01 - R$ 8.800,00)	8 3%	7 4.9%	15 3.7%
>3-5 MS (R$ 2.640,01 - R$ 4.440,00)	28 10.6%	10 7%	38 9.3%
>2-3 MS (R$ 1.760,01 - R$ 2.640,00)	25 9.5%	12 8.4%	37 9.1%
>1-2 MS (R$ 880,01 - R$ 1.760,00)	49 18.6%	16 11.2%	65 16%
>1/2-1 MS (R$ 440,01 - R$ 880,00)	18 6.8%	7 4.9%	25 6.1%
≤1/2 MS (Until R$ 440,00 (Including))	1 0.4%	1 0.7%	2 0.5%
No Income	25 9.5%	14 9.8%	39 9.6%
Unknown/Not Informed	105 39.8%	74 51.7%	179 44%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	166.0 (9.89)	165.1 (10.70)	165.7 (10.18)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	69.0 (14.52)	70.1 (14.33)	69.4 (14.45)
(Body Mass Index) BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.1 (4.67)	25.7 (4.63)	25.3 (4.66)
Smoking Status (Count of Participants)
Never Smoked	171 64.8%	91 63.6%	262 64.4%
Former Smoker	47 17.8%	38 26.6%	85 20.9%
Current Smoker	24 9.1%	3 2.1%	27 6.6%
Unknown	22 8.3%	11 7.7%	33 8.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Active Crohn's Disease (CD) at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease
Arm/Group Description	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.
Measure Participants	264
HBI Score ≥8	16.52 6.3%
CDAI Score ≥220	25.97 9.8%

2. Primary Outcome

Title	Number of Participants With Active Ulcerative Colitis (UC) at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Ulcerative Colitis
Arm/Group Description	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.
Measure Participants	141
Number [participants]	36 13.6%

3. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
Age ≥18-39 years old	52 19.7%	15 10.5%
Age ≥40-59 years old	49 18.6%	15 10.5%
Age ≥ 60 years old	17 6.4%	6 4.2%
Gender, Male	49 18.6%	10 7%
Gender, Female	69 26.1%	26 18.2%
Professional Status, Employed	36 13.6%	5 3.5%
Professional Status, Unemployed	31 11.7%	8 5.6%
Professional Status, Student	2 0.8%	3 2.1%
Professional Status, Retired	13 4.9%	6 4.2%
Professional Status, Other	16 6.1%	9 6.3%
Professional Status, Unknown	20 7.6%	5 3.5%
Family History of IBD	15 5.7%	2 1.4%
Educational Level, Not Literate	1 0.4%	0 0%
Educational Level, Primary School	7 2.7%	3 2.1%
Educational Level, Primary School Not Completed	16 6.1%	6 4.2%
Educational Level, Secondary School	34 12.9%	5 3.5%
Educational Level, Secondary School Not Completed	3 1.1%	2 1.4%
Educational Level, Higher Education	23 8.7%	2 1.4%
Educational Level, Higher Education Not Completed	6 2.3%	3 2.1%
Educational Level, Post-Graduate/MBA	3 1.1%	0 0%
Educational Level, Unknown	25 9.5%	15 10.5%
Income, >10-20 MS (R$ 8.800,01 - R$ 17.600,00)	3 1.1%	1 0.7%
Income, >5-10 MS (R$ 4.400,01 - R$ 8.800,00)	1 0.4%	1 0.7%
Income, >3-5 MS (R$ 2.640,01 - R$ 4.440,00)	13 4.9%	1 0.7%
Income, >2-3 MS (R$ 1.760,01 - R$ 2.640,00)	10 3.8%	1 0.7%
Income, >1-2 MS (R$ 880,01 - R$ 1.760,00)	19 7.2%	2 1.4%
Income, >½-1 MS (R$ 440,01 - R$ 880,00)	10 3.8%	2 1.4%
Income, ≤½ MS (Until R$ 440,00 (Including))	1 0.4%	0 0%
Income, No Income	10 3.8%	6 4.2%
Income, Unknown	31 11.7%	10 7%
Income, Not Informed	20 7.6%	12 8.4%

4. Secondary Outcome

Title	Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
CD or UC, Moderate to Severe Activity	118 44.7%	36 25.2%
Height (cm)	NA NaN	NA NaN
Weight (kg)	NA NaN	NA NaN
BMI - <24 Kg/m^2	54 20.5%	23 16.1%
BMI - 25 - 30 Kg/m^2	43 16.3%	7 4.9%
BMI - ≥30 Kg/m^2	13 4.9%	5 3.5%
Family History of IBD	15 5.7%	2 1.4%
Smoking Status, Never Smoked	84 31.8%	25 17.5%
Smoking Status, Former Smoker	15 5.7%	9 6.3%
Smoking Status, Current smoker	7 2.7%	0 0%
Medical History, Comorbidity or EIM	66 25%	20 14%
Location of CD, L1	22 8.3%
Location of CD, L1+L4	4 1.5%
Location of CD, L2	21 8%
Location of CD, L3	70 26.5%
Location of CD, L3+L4	1 0.4%
Behavior, B1	26 9.8%
Behavior, B1+P	5 1.9%
Behavior, B2	39 14.8%
Behavior, B2+P	13 4.9%
Behavior, B3	11 4.2%
Behavior, B3+P	24 9.1%
Extent Inflammation, E1-Distal: Proctitis	5 1.9%
Extent Inflammation, E1-Distal: Proctosigmoiditis	5 1.9%
Extent of Inflammation, E2-Left-sided	8 3%
Extent of Inflammation, E3-Pancolitis	18 6.8%
Severity, S1-Mild UC	3 1.1%
Severity, S2-Moderate UC	25 9.5%
Severity, S3-Severe UC	8 3%
Steroid Behavior, Steroid-dependent	17 6.4%	10 7%
Steroid Behavior, Steroid-refractory Disease	5 1.9%	3 2.1%
Colonoscopy	104 39.4%	29 20.3%
Calprotectin >200ug/g	13 4.9%	NA NaN

5. Secondary Outcome

Title	Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
Salycyclic Derivates	16.9 6.4%	75.0 52.4%
Corticosteroids	14.4 5.5%	36.1 25.2%
Immunosuppresors	67.8 25.7%	47.2 33%
Biologic Therapy	66.9 25.3%	30.6 21.4%
Antibiotics	9.3 3.5%	13.9 9.7%
Surgeries	27.1 10.3%	2.8 2%
Others	5.9 2.2%	16.7 11.7%

6. Secondary Outcome

Title	Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
Infliximab	33.1 12.5%	16.7 11.7%
Adalimumab	30.5 11.6%	11.1 7.8%
Vedolizumab	2.5 0.9%	5.6 3.9%
Certolizumab	0.8 0.3%	0.0 0%
Ustekimumab	0.8 0.3%	0.0 0%

7. Secondary Outcome

Title	Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies
Description	IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
Number [percentage of participants]	36.4 13.8%	33.3 23.3%

8. Secondary Outcome

Title	Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1
Description	Participants with moderate to severe CD or UC ongoing IBD treatment at Day 1 were reported.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
Number [percentage of participants]	94.1 35.6%	88.9 62.2%

9. Secondary Outcome

Title	Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables
Description	Socio-demographic variables included gender and professional status.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Crohn's Disease (Moderate to Severe Activity)	Crohn's Disease (Mild or No Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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 IBD and CD at Day 1 were followed up for 12 months in prospective phase.	Participants with diagnosis of mild Crohn's disease (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.
Measure Participants	118	146
Gender, Male	49 18.6%	72 50.3%
Gender, Female	69 26.1%	74 51.7%
Professional Status, Employed	36 13.6%	65 45.5%
Professional Status, Unemployed	31 11.7%	30 21%
Professional Status, Student	2 0.8%	8 5.6%
Professional Status, Retired	13 4.9%	17 11.9%
Professional Status, Other	16 6.1%	10 7%
Professional Status, Unknown	20 7.6%	16 11.2%

10. Secondary Outcome

Title	Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Crohn's Disease (Moderate to Severe Activity)	Crohn's Disease (Mild or No Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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 IBD and CD at Day 1 were followed up for 12 months in prospective phase.	Participants with diagnosis of mild Crohn's disease (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.
Measure Participants	118	146
Family History of IBD	15 5.7%	18 12.6%
Smoking Status, Never Smoked	84 31.8%	87 60.8%
Smoking Status, Former Smoker	15 5.7%	32 22.4%
Smoking Status, Current smoker	7 2.7%	17 11.9%
Medical History, Comorbidity or EIM	66 25%	77 53.8%
Location of CD, L1	22 8.3%	39 27.3%
Location of CD, L1+L4	4 1.5%	2 1.4%
Location of CD, L2	21 8%	21 14.7%
Location of CD, L3	70 26.5%	74 51.7%
Location of CD, L3+L4	1 0.4%	5 3.5%
Behavior, B1	26 9.8%	20 14%
Behavior, B1+P	5 1.9%	7 4.9%
Behavior, B2	39 14.8%	40 28%
Behavior, B2+P	13 4.9%	18 12.6%
Behavior, B3	11 4.2%	23 16.1%
Behavior, B3+P	24 9.1%	33 23.1%
Behavior, P	0 0%	5 3.5%
Steroid Behavior, Steroid-dependent	17 6.4%	14 9.8%
Steroid Behavior, Steroid-refractory disease	5 1.9%	11 7.7%
Colonoscopy	104 39.4%	107 74.8%
Calprotectin >200ug/g	41 15.5%	38 26.6%

11. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Crohn's Disease (Moderate to Severe Activity)	Crohn's Disease (Mild or No Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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 IBD and CD at Day 1 were followed up for 12 months in prospective phase.	Participants with diagnosis of mild Crohn's disease (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.
Measure Participants	118	146
Type of Therapy, Salicylic Derivates	20 7.6%	19 13.3%
Type of Therapy, Corticosteroids	17 6.4%	13 9.1%
Type of Therapy, Immunosuppressors	80 30.3%	98 68.5%
Type of Therapy, Biologic Therapy	79 29.9%	110 76.9%
Type of Therapy, Antibiotics	11 4.2%	3 2.1%
Type of Therapy, Other	7 2.7%	6 4.2%
Previous Surgery	32 12.1%	35 24.5%

12. Secondary Outcome

Title	Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables
Description	Socio-demographic variables included gender and professional status.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Ulcerative Colitis (Moderate to Severe Activity)	Ulcerative Colitis (Mild or No Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe ulcerative colitis (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.	Participants with diagnosis of mild ulcerative colitis (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.
Measure Participants	36	107
Gender, Male	10 3.8%	52 36.4%
Gender, Female	26 9.8%	55 38.5%
Professional Status, Employed	5 1.9%	48 33.6%
Professional Status, Unemployed	8 3%	25 17.5%
Professional Status, Student	3 1.1%	2 1.4%
Professional Status, Retired	6 2.3%	9 6.3%
Professional Status, Other	9 3.4%	9 6.3%
Professional Status, Unknown	5 1.9%	14 9.8%

13. Secondary Outcome

Title	Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Ulcerative Colitis (Moderate to Severe Activity)	Ulcerative Colitis (Mild or No Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe ulcerative colitis (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.	Participants with diagnosis of mild ulcerative colitis (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.
Measure Participants	36	107
Family History of IBD	2 0.8%	13 9.1%
Smoking Status, Never Smoked	25 9.5%	66 46.2%
Smoking Status, Former Smoker	9 3.4%	29 20.3%
Smoking status, Current smoker	0 0%	3 2.1%
Medical History, Comorbidity or EIM	20 7.6%	59 41.3%
Extent Inflammation, E1-Distal: Proctitis	5 1.9%	12 8.4%
Extent Inflammation, E1-Distal: Proctosigmoiditis	5 1.9%	21 14.7%
Extent of Inflammation, E2-Left-sided	8 3%	18 12.6%
Extent of Inflammation, E3-Pancolitis	18 6.8%	56 39.2%
Severity, S0-Clinical Remission	0 0%	57 39.9%
Severity, S1-Mild UC	3 1.1%	29 20.3%
Severity, S2-Moderate UC	25 9.5%	15 10.5%
Severity, S3-Severe UC	8 3%	6 4.2%
Steroid Behavior, Steroid-dependent	10 3.8%	13 9.1%
Steroid Behavior, Steroid-refractory disease	3 1.1%	8 5.6%
Colonoscopy	29 11%	87 60.8%

14. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Ulcerative Colitis (Moderate to Severe Activity)	Ulcerative Colitis (Mild or No Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe ulcerative colitis (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.	Participants with diagnosis of mild ulcerative colitis (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.
Measure Participants	36	107
Type of Therapy, Salicylic Derivates	75.0 28.4%	68.2 47.7%
Type of Therapy, Corticosteroids	36.1 13.7%	12.1 8.5%
Type of Therapy, Immunosuppressors	47.2 17.9%	43.0 30.1%
Type of Therapy, Biologic Therapy	30.6 11.6%	28.0 19.6%
Type of Therapy, Antibiotics	13.9 5.3%	1.9 1.3%
Type of Therapy, Other	16.7 6.3%	7.9 5.5%
Previous Surgery	2.8 1.1%	2.8 2%

15. Secondary Outcome

Title	Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease
Arm/Group Description	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.
Measure Participants	40
Day 1	7.2 (8.53)
Month 12	3.7 (3.68)

16. Secondary Outcome

Title	Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease
Arm/Group Description	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.
Measure Participants	40
Day 1	197.3 (124.44)
Month 12	122.0 (68.82)

17. Secondary Outcome

Title	Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	10
Day 1	5.4 (0.52)
Month 12	2.3 (2.16)

18. Secondary Outcome

Title	Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason
Description	One participant could have more than one reason for discontinuation.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Longitudinal population included all participants who were eligible for the prospective period (participants with active IBD at Day 1).

Arm/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	111	36
Adverse Reaction	7.1 2.7%	3.8 2.7%
Comorbidity	0.4 0.2%	0.0 0%
Contraindication	0.0 0%	1.3 0.9%
Pregnancy	0.4 0.2%	3.2 2.2%
Surgery	0.7 0.3%	0.0 0%
Weight change	0.4 0.2%	0.0 0%
Poor Effectiveness	10.6 4%	12.4 8.7%
Remission	11.0 4.2%	27.5 19.2%
Patient decision	1.8 0.7%	5.0 3.5%
Patient poor adherence	3.2 1.2%	1.3 0.9%
Patient access to the treatment	0.7 0.3%	0.0 0%
Other	25.1 9.5%	2.5 1.7%
Unknown	38.9 14.7%	46.3 32.4%

19. Secondary Outcome

Title	Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
Mean (Standard Deviation) [score on a scale]	68.9 (22.14)	55.2 (22.44)

20. Secondary Outcome

Title	Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
Mental Component Score	42.6 (12.00)	36.4 (13.48)
Physical Component Score	43.3 (10.15)	40.8 (9.13)

21. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease	Ulcerative Colitis
Arm/Group Description	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.	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.
Measure Participants	263	142
Mean (Standard Deviation) [score on a scale]	158.9 (41.41)	153.2 (49.66)

22. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease	Ulcerative Colitis
Arm/Group Description	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.	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.
Measure Participants	263	142
Bowel Systems	5.4 (1.24)	5.1 (1.63)
Emotional Health	4.7 (1.46)	4.6 (1.64)
Systemic Systems	4.6 (1.48)	4.5 (1.64)
Social Function	5.2 (1.58)	5.0 (1.81)

23. Secondary Outcome

Title	Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease	Ulcerative Colitis
Arm/Group Description	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.	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.
Measure Participants	264	143
Percentage of Total Work Productivity Impairment	32.3 (32.97)	25.3 (33.13)
Percentage of Total Activity Impairment	35.8 (33.49)	39.9 (37.45)

24. Secondary Outcome

Title	Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Crohn's Disease	Ulcerative Colitis
Arm/Group Description	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.	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.
Measure Participants	98	50
Mean (Standard Deviation) [percentage of work time missed]	12.6 (23.78)	11.7 (26.69)

25. Secondary Outcome

Title	Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Crohn's Disease	Ulcerative Colitis
Arm/Group Description	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.	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.
Measure Participants	110	57
Mean (Standard Deviation) [percentage of impairment while working]	24.4 (27.94)	17.5 (26.00)

26. Secondary Outcome

Title	Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI
Description	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

Outcome Measure Data

Analysis Population Description

Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).

Arm/Group Title	Crohn's Disease	Ulcerative Colitis
Arm/Group Description	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.	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.
Measure Participants	264	142
Mean (Standard Deviation) [percentage of total activity impairment]	35.8 (33.49)	39.9 (37.45)

27. Secondary Outcome

Title	Percentage of Participants Who Used Healthcare Resources
Description	Healthcare resources used in the previous 3 years included imaging and laboratory testing, surgeries, hospitalizations, and consultations.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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/Group Title	Crohn's Disease (Moderate to Severe Activity)	Ulcerative Colitis (Moderate to Severe Activity)
Arm/Group Description	Participants with diagnosis of moderate to severe Crohn's disease (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.	Participants with diagnosis of moderate to severe ulcerative colitis (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.
Measure Participants	118	36
Previous Imaging and Laboratory Testing Due to IBD	98.3 37.2%	100.0 69.9%
Previous Surgery for IBD	27.1 10.3%	2.8 2%
Previous Hospitalization Due to IBD	43.2 16.4%	30.6 21.4%
Previous Medical Appointments Due to IBD	99.2 37.6%	100.0 69.9%

Adverse Events

Time Frame	Up to Month 12
Adverse Event Reporting Description	Data of adverse events or adverse drug reactions were not collected as part of the study database.
Arm/Group Title	Crohn's Disease		Ulcerative Colitis
Arm/Group Description	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.		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.
All Cause Mortality
	Crohn's Disease		Ulcerative Colitis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/264 (0.4%)		0/143 (0%)
Serious Adverse Events
	Crohn's Disease		Ulcerative Colitis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Crohn's Disease		Ulcerative Colitis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Missing data on paticipants medical records in retrospective analysis and missing information in medical activity scores of participants in prospective analysis resulted in improper collection of data for IBD participants.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.