Trial Outcomes & Findings for Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil (NCT NCT02822235)

Last Updated: 2020-02-25

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

407 participants

Primary outcome timeframe

Day 1

Results posted on

2020-02-25

Participant Flow

Participants took part in the study at the 14 investigative sites in Brazil from 11 October 2016 to 19 Feb 2018.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Cross-sectional Phase (Day 1) STARTED	264	143
Cross-sectional Phase (Day 1) COMPLETED	118	36
Cross-sectional Phase (Day 1) NOT COMPLETED	146	107
Prospective Phase (Day 1 up to Month 12) STARTED	118	36
Prospective Phase (Day 1 up to Month 12) COMPLETED	107	34
Prospective Phase (Day 1 up to Month 12) NOT COMPLETED	11	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
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) Withdrawal of Consent	0	1
Prospective Phase (Day 1 up to Month 12) Lost to Follow-up	4	0
Prospective Phase (Day 1 up to Month 12) Death	1	0
Prospective Phase (Day 1 up to Month 12) Reason Not Specified	6	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crohn's Disease n=264 Participants 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.	Ulcerative Colitis n=143 Participants 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 n=407 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 12.96 • n=264 Participants	45.9 years STANDARD_DEVIATION 13.83 • n=143 Participants	43.9 years STANDARD_DEVIATION 13.34 • n=407 Participants
Sex: Female, Male Female	143 Participants n=264 Participants	81 Participants n=143 Participants	224 Participants n=407 Participants
Sex: Female, Male Male	121 Participants n=264 Participants	62 Participants n=143 Participants	183 Participants n=407 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Brazil	264 Participants n=264 Participants	143 Participants n=143 Participants	407 Participants n=407 Participants
Professional Situation Employed	101 Participants n=264 Participants	53 Participants n=143 Participants	154 Participants n=407 Participants
Professional Situation Unemployed	61 Participants n=264 Participants	33 Participants n=143 Participants	94 Participants n=407 Participants
Professional Situation Student	10 Participants n=264 Participants	5 Participants n=143 Participants	15 Participants n=407 Participants
Professional Situation Retired	30 Participants n=264 Participants	15 Participants n=143 Participants	45 Participants n=407 Participants
Professional Situation Other	26 Participants n=264 Participants	18 Participants n=143 Participants	44 Participants n=407 Participants
Professional Situation Unknown	36 Participants n=264 Participants	19 Participants n=143 Participants	55 Participants n=407 Participants
Educational Level Not Literate	3 Participants n=264 Participants	0 Participants n=143 Participants	3 Participants n=407 Participants
Educational Level Primary School	26 Participants n=264 Participants	11 Participants n=143 Participants	37 Participants n=407 Participants
Educational Level Primary School Not Completed	26 Participants n=264 Participants	27 Participants n=143 Participants	53 Participants n=407 Participants
Educational Level Secondary School	74 Participants n=264 Participants	33 Participants n=143 Participants	107 Participants n=407 Participants
Educational Level Secondary School Not Completed	9 Participants n=264 Participants	4 Participants n=143 Participants	13 Participants n=407 Participants
Educational Level Higher Education	46 Participants n=264 Participants	14 Participants n=143 Participants	60 Participants n=407 Participants
Educational Level Higher Education Not Completed	18 Participants n=264 Participants	8 Participants n=143 Participants	26 Participants n=407 Participants
Educational Level Post-graduate/Master of Business Administration	5 Participants n=264 Participants	1 Participants n=143 Participants	6 Participants n=407 Participants
Educational Level Unknown	57 Participants n=264 Participants	45 Participants n=143 Participants	102 Participants n=407 Participants
Income >10-20 MS (R$ 8.800,01- R$ 17.600,00)	5 Participants n=264 Participants	2 Participants n=143 Participants	7 Participants n=407 Participants
Income > 5-10 MS (R$ 4.400,01 - R$ 8.800,00)	8 Participants n=264 Participants	7 Participants n=143 Participants	15 Participants n=407 Participants
Income >3-5 MS (R$ 2.640,01 - R$ 4.440,00)	28 Participants n=264 Participants	10 Participants n=143 Participants	38 Participants n=407 Participants
Income >2-3 MS (R$ 1.760,01 - R$ 2.640,00)	25 Participants n=264 Participants	12 Participants n=143 Participants	37 Participants n=407 Participants
Income >1-2 MS (R$ 880,01 - R$ 1.760,00)	49 Participants n=264 Participants	16 Participants n=143 Participants	65 Participants n=407 Participants
Income >1/2-1 MS (R$ 440,01 - R$ 880,00)	18 Participants n=264 Participants	7 Participants n=143 Participants	25 Participants n=407 Participants
Income ≤1/2 MS (Until R$ 440,00 (Including))	1 Participants n=264 Participants	1 Participants n=143 Participants	2 Participants n=407 Participants
Income No Income	25 Participants n=264 Participants	14 Participants n=143 Participants	39 Participants n=407 Participants
Income Unknown/Not Informed	105 Participants n=264 Participants	74 Participants n=143 Participants	179 Participants n=407 Participants
Height	166.0 cm STANDARD_DEVIATION 9.89 • n=250 Participants • Number analyzed is the number of participants with data available for height.	165.1 cm STANDARD_DEVIATION 10.70 • n=136 Participants • Number analyzed is the number of participants with data available for height.	165.7 cm STANDARD_DEVIATION 10.18 • n=386 Participants • Number analyzed is the number of participants with data available for height.
Weight	69.0 kg STANDARD_DEVIATION 14.52 • n=262 Participants • Number analyzed is the number of participants with data available for weight.	70.1 kg STANDARD_DEVIATION 14.33 • n=141 Participants • Number analyzed is the number of participants with data available for weight.	69.4 kg STANDARD_DEVIATION 14.45 • n=403 Participants • Number analyzed is the number of participants with data available for weight.
(Body Mass Index) BMI	25.1 kg/m^2 STANDARD_DEVIATION 4.67 • n=249 Participants • Number analyzed is the number of participants with available for BMI.	25.7 kg/m^2 STANDARD_DEVIATION 4.63 • n=136 Participants • Number analyzed is the number of participants with available for BMI.	25.3 kg/m^2 STANDARD_DEVIATION 4.66 • n=385 Participants • Number analyzed is the number of participants with available for BMI.
Smoking Status Never Smoked	171 Participants n=264 Participants	91 Participants n=143 Participants	262 Participants n=407 Participants
Smoking Status Former Smoker	47 Participants n=264 Participants	38 Participants n=143 Participants	85 Participants n=407 Participants
Smoking Status Current Smoker	24 Participants n=264 Participants	3 Participants n=143 Participants	27 Participants n=407 Participants
Smoking Status Unknown	22 Participants n=264 Participants	11 Participants n=143 Participants	33 Participants n=407 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=264 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) 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.
Percentage of Participants With Active Crohn's Disease (CD) at Day 1 HBI Score ≥8	16.52 percentage of participants	—
Percentage of Participants With Active Crohn's Disease (CD) at Day 1 CDAI Score ≥220	25.97 percentage of participants	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=141 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) 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.
Number of Participants With Active Ulcerative Colitis (UC) at Day 1	36 participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
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	15 Participants
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	15 Participants
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	6 Participants
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	10 Participants
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	26 Participants
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	5 Participants
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	8 Participants
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	3 Participants
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	6 Participants
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	9 Participants
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	5 Participants
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	2 Participants
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	0 Participants
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	3 Participants
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	6 Participants
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	5 Participants
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	2 Participants
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	2 Participants
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	3 Participants
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	0 Participants
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	15 Participants
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	1 Participants
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	1 Participants
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	1 Participants
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	1 Participants
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	2 Participants
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	2 Participants
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	0 Participants
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	6 Participants
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	10 Participants
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	12 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables CD or UC, Moderate to Severe Activity	118 Participants	36 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Height (cm)	NA Participants Data was not collected according to the pre-defined categories.	NA Participants Data was not collected according to the pre-defined categories.
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Weight (kg)	NA Participants Data was not collected according to the pre-defined categories.	NA Participants Data was not collected according to the pre-defined categories.
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables BMI - <24 Kg/m^2	54 Participants	23 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables BMI - 25 - 30 Kg/m^2	43 Participants	7 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables BMI - ≥30 Kg/m^2	13 Participants	5 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Family History of IBD	15 Participants	2 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Smoking Status, Never Smoked	84 Participants	25 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Smoking Status, Former Smoker	15 Participants	9 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Smoking Status, Current smoker	7 Participants	0 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Medical History, Comorbidity or EIM	66 Participants	20 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Location of CD, L1	22 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Location of CD, L1+L4	4 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Location of CD, L2	21 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Location of CD, L3	70 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Location of CD, L3+L4	1 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Behavior, B1	26 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Behavior, B1+P	5 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Behavior, B2	39 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Behavior, B2+P	13 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Behavior, B3	11 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Behavior, B3+P	24 Participants	—
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Extent Inflammation, E1-Distal: Proctitis	—	5 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Extent Inflammation, E1-Distal: Proctosigmoiditis	—	5 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Extent of Inflammation, E2-Left-sided	—	8 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Extent of Inflammation, E3-Pancolitis	—	18 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Severity, S1-Mild UC	—	3 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Severity, S2-Moderate UC	—	25 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Severity, S3-Severe UC	—	8 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Steroid Behavior, Steroid-dependent	17 Participants	10 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Steroid Behavior, Steroid-refractory Disease	5 Participants	3 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Colonoscopy	104 Participants	29 Participants
Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables Calprotectin >200ug/g	13 Participants	NA Participants Calprotectin levels was not applicable for UC participants as established in the protocol.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
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	75.0 percentage of participants
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	36.1 percentage of participants
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	47.2 percentage of participants
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	30.6 percentage of participants
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	13.9 percentage of participants
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	2.8 percentage of participants
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	16.7 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years Infliximab	33.1 percentage of participants	16.7 percentage of participants
Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years Adalimumab	30.5 percentage of participants	11.1 percentage of participants
Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years Vedolizumab	2.5 percentage of participants	5.6 percentage of participants
Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years Certolizumab	0.8 percentage of participants	0.0 percentage of participants
Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years Ustekimumab	0.8 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Day 1

IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies	36.4 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Day 1

Participants with moderate to severe CD or UC ongoing IBD treatment at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1	94.1 percentage of participants	88.9 percentage of participants

SECONDARY outcome

Timeframe: Day 1

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

Socio-demographic variables included gender and professional status.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=146 Participants 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.
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	72 Participants
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	74 Participants
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	65 Participants
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	30 Participants
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	8 Participants
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	17 Participants
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	10 Participants
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	16 Participants

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=146 Participants 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.
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	18 Participants
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	87 Participants
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	32 Participants
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	17 Participants
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	77 Participants
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	39 Participants
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	2 Participants
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	21 Participants
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	74 Participants
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	5 Participants
Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables Behavior, B1	26 Participants	20 Participants
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	7 Participants
Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables Behavior, B2	39 Participants	40 Participants
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	18 Participants
Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables Behavior, B3	11 Participants	23 Participants
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	33 Participants
Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables Behavior, P	0 Participants	5 Participants
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	14 Participants
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	11 Participants
Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables Colonoscopy	104 Participants	107 Participants
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	38 Participants

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=146 Participants 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.
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	19 Participants
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	13 Participants
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	98 Participants
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	110 Participants
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	3 Participants
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	6 Participants
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	35 Participants

SECONDARY outcome

Timeframe: Day 1

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

Socio-demographic variables included gender and professional status.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=36 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=107 Participants 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.
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	52 Participants
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	55 Participants
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	48 Participants
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	25 Participants
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	2 Participants
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	9 Participants
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	9 Participants
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	14 Participants

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=36 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=107 Participants 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.
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	13 Participants
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	66 Participants
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	29 Participants
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	3 Participants
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	59 Participants
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	12 Participants
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	21 Participants
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	18 Participants
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	56 Participants
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	57 Participants
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	29 Participants
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	15 Participants
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	6 Participants
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	13 Participants
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	8 Participants
Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables Colonoscopy	29 Participants	87 Participants

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=36 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=107 Participants 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.
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	7.9 percentage of participants
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	2.8 percentage of participants
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	68.2 percentage of participants
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	12.1 percentage of participants
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	43.0 percentage of participants
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	28.0 percentage of participants
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	1.9 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=40 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) 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.
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	—
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=40 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) 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.
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	—
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	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=10 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) 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.
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	—
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 outcome

Timeframe: Month 12

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

One participant could have more than one reason for discontinuation.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=111 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
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	3.8 percentage of participants
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	0.0 percentage of participants
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	1.3 percentage of participants
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	3.2 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	12.4 percentage of participants
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	27.5 percentage of participants
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	5.0 percentage of participants
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	1.3 percentage of participants
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	0.0 percentage of participants
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	2.5 percentage of participants
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	46.3 percentage of participants

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
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	55.2 score on a scale Standard Deviation 22.44

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
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 12.00	36.4 score on a scale Standard Deviation 13.48
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	40.8 score on a scale Standard Deviation 9.13

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=263 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=142 Participants 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.
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1	158.9 score on a scale Standard Deviation 41.41	153.2 score on a scale Standard Deviation 49.66

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=263 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=142 Participants 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.
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 Bowel Systems	5.4 score on a scale Standard Deviation 1.24	5.1 score on a scale Standard Deviation 1.63
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 Emotional Health	4.7 score on a scale Standard Deviation 1.46	4.6 score on a scale Standard Deviation 1.64
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 Systemic Systems	4.6 score on a scale Standard Deviation 1.48	4.5 score on a scale Standard Deviation 1.64
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 Social Function	5.2 score on a scale Standard Deviation 1.58	5.0 score on a scale Standard Deviation 1.81

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=264 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=143 Participants 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.
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	25.3 percentage of total work impairment Standard Deviation 33.13
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	39.9 percentage of total work impairment Standard Deviation 37.45

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=98 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=50 Participants 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.
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	11.7 percentage of work time missed Standard Deviation 26.69

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=110 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=57 Participants 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.
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	17.5 percentage of impairment while working Standard Deviation 26.00

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure	Crohn's Disease n=264 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=142 Participants 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.
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	39.9 percentage of total activity impairment Standard Deviation 37.45

SECONDARY outcome

Timeframe: Day 1

Healthcare resources used in the previous 3 years included imaging and laboratory testing, surgeries, hospitalizations, and consultations.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=118 Participants 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.	Ulcerative Colitis (Moderate to Severe Activity) n=36 Participants 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.
Percentage of Participants Who Used Healthcare Resources Previous Imaging and Laboratory Testing Due to IBD	98.3 percentage of participants	100.0 percentage of participants
Percentage of Participants Who Used Healthcare Resources Previous Surgery for IBD	27.1 percentage of participants	2.8 percentage of participants
Percentage of Participants Who Used Healthcare Resources Previous Hospitalization Due to IBD	43.2 percentage of participants	30.6 percentage of participants
Percentage of Participants Who Used Healthcare Resources Previous Medical Appointments Due to IBD	99.2 percentage of participants	100.0 percentage of participants

Adverse Events

Crohn's Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Ulcerative Colitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER