Trial Outcomes & Findings for A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) (NCT NCT03488030)

Last Updated: 2022-02-08

Results Overview

Percentage of participants with active CD were observed, where active CD was defined as Harvey Bradshaw index (HBI) greater than or equal to (\>=) 8 or Crohn's disease active index (CDAI) \>= 220 points. CDAI assessed CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranged from 0 to 600 points. Higher score indicated more severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score was sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicated more severe disease.

Recruitment status

COMPLETED

Target enrollment

246 participants

Primary outcome timeframe

Day 1

Results posted on

2022-02-08

Participant Flow

Participants took part in the study at 7 investigative sites in Argentina from 12 December 2018 to 31 May 2019.

Participants diagnosed with moderate to severe Inflammatory Bowel Disease (IBD)- Crohn's disease (CD) or ulcerative colitis (UC) were observed on Day 1 with retrospective data collection for previous 3 years.

Participant milestones

Participant milestones
Measure	Crohn's Disease Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Overall Study STARTED	101	145
Overall Study COMPLETED	101	145
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Total n=246 Participants Total of all reporting groups
Age, Continuous	42.92 years STANDARD_DEVIATION 14.50 • n=101 Participants	45.61 years STANDARD_DEVIATION 15.83 • n=145 Participants	44.51 years STANDARD_DEVIATION 15.32 • n=246 Participants
Sex: Female, Male Female	51 Participants n=101 Participants	79 Participants n=145 Participants	130 Participants n=246 Participants
Sex: Female, Male Male	50 Participants n=101 Participants	66 Participants n=145 Participants	116 Participants n=246 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Argentina	101 Participants n=101 Participants	145 Participants n=145 Participants	246 Participants n=246 Participants
Professional Situation Employed	66 Participants n=101 Participants	88 Participants n=145 Participants	154 Participants n=246 Participants
Professional Situation Unemployed	12 Participants n=101 Participants	17 Participants n=145 Participants	29 Participants n=246 Participants
Professional Situation Student	4 Participants n=101 Participants	6 Participants n=145 Participants	10 Participants n=246 Participants
Professional Situation Retired	11 Participants n=101 Participants	23 Participants n=145 Participants	34 Participants n=246 Participants
Professional Situation Other	7 Participants n=101 Participants	11 Participants n=145 Participants	18 Participants n=246 Participants
Professional Situation Unknown	1 Participants n=101 Participants	0 Participants n=145 Participants	1 Participants n=246 Participants
Educational Level Not literate	0 Participants n=101 Participants	0 Participants n=145 Participants	0 Participants n=246 Participants
Educational Level Primary school	5 Participants n=101 Participants	6 Participants n=145 Participants	11 Participants n=246 Participants
Educational Level Primary school not completed	0 Participants n=101 Participants	4 Participants n=145 Participants	4 Participants n=246 Participants
Educational Level Secondary school	25 Participants n=101 Participants	33 Participants n=145 Participants	58 Participants n=246 Participants
Educational Level Secondary school not completed	8 Participants n=101 Participants	17 Participants n=145 Participants	25 Participants n=246 Participants
Educational Level Higher education	40 Participants n=101 Participants	59 Participants n=145 Participants	99 Participants n=246 Participants
Educational Level Higher education not completed	18 Participants n=101 Participants	17 Participants n=145 Participants	35 Participants n=246 Participants
Educational Level Post-graduate or MBA	4 Participants n=101 Participants	8 Participants n=145 Participants	12 Participants n=246 Participants
Educational Level Unknown	1 Participants n=101 Participants	1 Participants n=145 Participants	2 Participants n=246 Participants
Participant's Income No income	15 Participants n=101 Participants	22 Participants n=145 Participants	37 Participants n=246 Participants
Participant's Income From 30 dollar to 3.700 dollar	1 Participants n=101 Participants	0 Participants n=145 Participants	1 Participants n=246 Participants
Participant's Income From 3.700 dollar to 6.000 dollar	0 Participants n=101 Participants	2 Participants n=145 Participants	2 Participants n=246 Participants
Participant's Income From 6.000 dollar to 7.100 dollar	0 Participants n=101 Participants	0 Participants n=145 Participants	0 Participants n=246 Participants
Participant's Income From 7.100 dollar to 8.500 dollar	3 Participants n=101 Participants	1 Participants n=145 Participants	4 Participants n=246 Participants
Participant's Income From 8.500 dollar to 11.000 dollar	7 Participants n=101 Participants	10 Participants n=145 Participants	17 Participants n=246 Participants
Participant's Income From 11.000 dollar to 13.800 dollar	1 Participants n=101 Participants	3 Participants n=145 Participants	4 Participants n=246 Participants
Participant's Income From 13.800 dollar to 16.000 dollar	4 Participants n=101 Participants	5 Participants n=145 Participants	9 Participants n=246 Participants
Participant's Income From 16.000 dollar to 20.000 dollar	4 Participants n=101 Participants	9 Participants n=145 Participants	13 Participants n=246 Participants
Participant's Income From 20.000 dollar to 29.000 dollar	6 Participants n=101 Participants	12 Participants n=145 Participants	18 Participants n=246 Participants
Participant's Income From 29.000 dollar to 800.000 dollar	26 Participants n=101 Participants	43 Participants n=145 Participants	69 Participants n=246 Participants
Participant's Income Unknown	34 Participants n=101 Participants	38 Participants n=145 Participants	72 Participants n=246 Participants
Smoking Status Never smoked OR smoked less than 100 cigarettes	57 Participants n=101 Participants	84 Participants n=145 Participants	141 Participants n=246 Participants
Smoking Status Former smoker	31 Participants n=101 Participants	53 Participants n=145 Participants	84 Participants n=246 Participants
Smoking Status Current smoker	13 Participants n=101 Participants	8 Participants n=145 Participants	21 Participants n=246 Participants
Family History of IBD With IBD history	12 Participants n=101 Participants	8 Participants n=145 Participants	20 Participants n=246 Participants
Family History of IBD Without IBD history	88 Participants n=101 Participants	135 Participants n=145 Participants	223 Participants n=246 Participants
Family History of IBD Unknown	1 Participants n=101 Participants	2 Participants n=145 Participants	3 Participants n=246 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Analysis dataset for disease activity included all participants who fulfilled selection criteria, provided the written informed consent, were without major study protocol deviations, had completed the Day 1 assessment, and who had no ostomy.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=97 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Crohn's Disease: Percentage of Participants With Active CD at Day 1	9.3 percentage of participants Interval 4.3 to 16.9	—	—	—

PRIMARY outcome

Timeframe: Day 1

Percentage of participants with active disease UC disease were observed, where UC was defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score was composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0 to 3 that are summed to give a total score that ranges from 0 to 12. The pMayo score was previously compared with the full Mayo score and categorized participants as being in remission (score of 0 to 2), having mild disease (pMayo of 3 or 4) or moderate to severe disease (pMayo of \>=5).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=143 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Ulcerative Colitis: Percentage of Participants With Active UC at Day 1	7.7 percentage of participants Interval 3.9 to 13.3	—	—	—

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior Steroid-responsive disease	52 Participants	54 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior Steroid-dependent	28 Participants	71 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior Steroid-refractory disease	16 Participants	12 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior Not applicable (who did not use previously)	5 Participants	7 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior Unknown	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Day 1

Anthropometric information included height, weight and body mass index (BMI). BMI ranges: underweight (BMI less than \[\<\] 18.50 kilogram per square meter (kg/m\^2), normal range (BMI between 18.50 and 24.99 kg/m\^2), overweight (BMI between 25.00 and 29.99 kg/m\^2), obese (BMI \>=30.00 kg/m\^2).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information BMI, overweight	33 Participants	55 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information BMI, underweight	3 Participants	8 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information BMI, normal range	54 Participants	55 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information BMI, obese	11 Participants	27 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information 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 Anthropometric Information 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.	—	—

SECONDARY outcome

Timeframe: Day 1

Medical history was defined as an EIM or non-EIM according to the investigator's judgement.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe CD or UC Based on Medical History, Comorbidities or Extra Intestinal Manifestation (EIM) With medical history, comorbidity or EIM	49 Participants	74 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Based on Medical History, Comorbidities or Extra Intestinal Manifestation (EIM) Without medical history, comorbidity or EIM	52 Participants	71 Participants	—	—

SECONDARY outcome

Timeframe: Day 1

The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of two parameters: location and behavior of the disease activity. There were four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) was combined with L4 where disease sites coexisted. There were 4 different categories for the behavior of the disease activity: Behavior 1 (B1) was non stenosing or non penetrating; Behavior 2 (B2) was stenosing; Behavior 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Location, L3	33 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Location, L4	1 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Location, L1	9 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Location, L1+L4	2 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Location, L2	52 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Location, L2+L4	0 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Location, L3+L4	4 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Behavior, B1	35 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Behavior, B1+P	14 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Behavior, B2	23 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Behavior, B2+P	15 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Behavior, B3	9 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Behavior, B3+P	5 Participants	—	—	—
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Behavior, P	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Here "overall number of participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Montreal classification index for UC was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent of inflammation: Extent 1 (E1) =Ulcerative distal UC proctitis and proctosigmoiditis, Extent 2 (E2) =Left-sided mucosa inflammation extending up to splenic flexure and Extent 3 (E3) =Pancolitis mucosa inflammation up to proximal transverse colon and beyond. Severity of UC as S0=Clinical remission (asymptomatic),S1 =Mild UC (passage of four or fewer stools/day \[with or without blood\],absence of any systemic illness, and normal inflammatory markers),S2 =Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity),S3 =Severe UC (passage of at least 6 bloody stools daily, pulse rate of at least 90 beats per minute, temperature of at least 37.5 degree Celsius, hemoglobin of \<10.5 gram per 100 milliliter (g/100mL), and erythrocyte sedimentation rate (ESR) of at least 30 millimeter per hour (mm/h).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=143 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Extent Inflammation, E1-Distal: Proctitis	13 Participants	—	—	—
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Extent Inflammation, E1-Distal: Proctosigmoiditis	4 Participants	—	—	—
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Extent of Inflammation, E2	60 Participants	—	—	—
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Extent of Inflammation, E3	66 Participants	—	—	—
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Severity, S0	66 Participants	—	—	—
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Severity, S1	33 Participants	—	—	—
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Severity, S2	30 Participants	—	—	—
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Severity, S3	14 Participants	—	—	—

SECONDARY outcome

Timeframe: Within previous 3 years including Day 1

Various types of therapies for IBD included salicylic derivatives, corticosteroids, immunosuppressors, biologic therapy, antibiotics, nutrition support and others. One participant could use more than one therapy.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years Salicylic derivatives	63 Participants	142 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years Corticosteroids	56 Participants	101 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years Immunosuppressors	66 Participants	85 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years Biologic therapy	80 Participants	49 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years Antibiotics	14 Participants	13 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years Nutrition support	0 Participants	0 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years Other	9 Participants	25 Participants	—	—

SECONDARY outcome

Timeframe: Within previous 3 years including Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Participants available for this outcome measure at given time period were included for assessment.

Time between the beginning of IBD treatment until the end of treatment. For participants with ongoing IBD treatment at Day 1, stop date was considered as Day 1 date visit. Various types of therapies for IBD included salicylic derivates, corticosteroids, immunosuppressors, biologic therapy, antibiotics, nutrition support and others. One participant could use more than one therapy.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Duration of IBD Treatment During Previous 3 Years Antibiotics treatment	1.33 months Interval 0.26 to 35.97	0.59 months Interval 0.07 to 1.28	—	—
Duration of IBD Treatment During Previous 3 Years Salicylic derivates treatment	35.90 months Interval 0.52 to 35.97	33.11 months Interval 0.03 to 35.97	—	—
Duration of IBD Treatment During Previous 3 Years Corticosteroids treatment	3.74 months Interval 0.03 to 35.97	3.96 months Interval 0.03 to 35.97	—	—
Duration of IBD Treatment During Previous 3 Years Immunosuppressors treatment	21.13 months Interval 0.03 to 35.97	19.54 months Interval 0.03 to 35.97	—	—
Duration of IBD Treatment During Previous 3 Years Biologic therapy treatment	29.26 months Interval 0.03 to 35.97	17.97 months Interval 0.03 to 35.97	—	—

SECONDARY outcome

Timeframe: Within previous 3 years including Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided written informed consent, were without major protocol deviations, and who had completed Day 1 assessment. Here "overall number of participants analyzed" are participants who had biologic therapies, and who were available for assessment at given time period.

Biologic therapies included infliximab, adalimumab, vedolizumab, certolizumab, golimumab, and ustekimumab. For participants with ongoing biologic therapy at Day 1, stop date was considered as Day 1 date visit.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=71 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=43 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years Infliximab	17 Participants	23 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years Adalimumab	51 Participants	18 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years Vedolizumab	2 Participants	1 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years Certolizumab	1 Participants	0 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years Golimumab	0 Participants	1 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years Ustekimumab	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Within previous 3 years including Day 1

Outcome measures

Outcome measures
Measure	Crohn's Disease n=97 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=143 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Adverse reaction	4 Participants	0 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Pregnancy	1 Participants	2 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Surgery	4 Participants	0 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Poor effectiveness	16 Participants	8 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Remission	2 Participants	0 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Patient decision	0 Participants	3 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Patient poor adherence	1 Participants	0 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Patient access to treatment	1 Participants	1 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Other	0 Participants	1 Participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons End of treatment as expected	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe CD or UC Who Had IBD Treatment Initiation on Day 1	11 Participants	20 Participants	—	—

SECONDARY outcome

Timeframe: Day 1

Participants were stratified based on gender, professional status, educational level and income.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=9 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=88 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) n=11 Participants Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) n=132 Participants Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Gender, female	6 Participants	44 Participants	8 Participants	71 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, secondary school	4 Participants	20 Participants	2 Participants	31 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, missing values	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, no income	1 Participants	14 Participants	3 Participants	19 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 20.000 dollar to 29.000 dollar	0 Participants	6 Participants	1 Participants	11 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Gender, male	3 Participants	44 Participants	3 Participants	61 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Professional status, employed	5 Participants	58 Participants	6 Participants	81 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Professional status, unemployed	1 Participants	11 Participants	2 Participants	15 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Professional status, student	0 Participants	4 Participants	0 Participants	6 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Professional status, retired	2 Participants	9 Participants	1 Participants	21 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Professional status, other	1 Participants	5 Participants	2 Participants	9 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Professional status, unknown	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, not literate	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, primary school	0 Participants	4 Participants	0 Participants	5 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, primary school not completed	0 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, secondary school not completed	1 Participants	6 Participants	1 Participants	16 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, higher school	2 Participants	38 Participants	6 Participants	52 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, higher school not completed	1 Participants	16 Participants	0 Participants	17 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Educational level, Post-graduate/MBA	1 Participants	3 Participants	1 Participants	7 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 30 dollar to 3.700 dollar	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 3.700 dollar to 6.000 dollar	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 6.000 dollar to 7.100 dollar	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 7.100 dollar to 8.500 dollar	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 8.500 dollar to 11.000 dollar	2 Participants	5 Participants	2 Participants	7 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 11.000 dollar to 13.800 dollar	0 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 13.800 dollar to 16.000 dollar	0 Participants	3 Participants	0 Participants	5 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 16.000 dollar to 20.000 dollar	0 Participants	4 Participants	1 Participants	8 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from 29.000 dollar to 800.000 dollar	1 Participants	23 Participants	2 Participants	40 Participants
Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables Income, from unknown values	3 Participants	31 Participants	2 Participants	36 Participants

SECONDARY outcome

Timeframe: Day 1

EQ-5D considered five attributes of quality of life evaluation, that is, mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension had five possible levels: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems), and; 5 (extreme problems). EQ-5D also included an additional visual analogic scale (EQ-VAS), which ranged from 0 to 100, where 0 indicated worst imaginable health state and 100 was best imaginable health state.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Quality of Life Assessed by European Quality of Life 5-dimension (EQ-5D) Health States Visual Analogue Scale (VAS) Score at Day 1	74.82 score on a scale Standard Deviation 17.37	75.74 score on a scale Standard Deviation 16.40	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Participants available for this outcome measure at given time period were included for the assessment.

The SF-36 evaluated 8 health dimensions: physical functioning, bodily pain, role physical (limitations due to physical problems), role emotional (limitations due to personal or emotional problems), mental health, social functioning, vitality, and general health perceptions. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score was generated which ranged 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 was generated which ranged between 0 and 100, with higher scores indicating a better quality of life.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Quality of Life as Assessed by 36-item Short Form Health Survey (SF-36) Component Score at Day 1 PCS score	50.47 score on a scale Standard Deviation 7.95	50.37 score on a scale Standard Deviation 7.06	—	—
Quality of Life as Assessed by 36-item Short Form Health Survey (SF-36) Component Score at Day 1 MCS score	43.61 score on a scale Standard Deviation 11.27	45.85 score on a scale Standard Deviation 10.09	—	—

SECONDARY outcome

Timeframe: Day 1

The IBDQ was a 32-item questionnaire that measured 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the sum of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best. The sub-score ranged from 8 to 56 and thus the total score ranged from 32 to 224, where higher score indicating better quality of life.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1	22.07 score on a scale Standard Deviation 4.64	22.38 score on a scale Standard Deviation 4.30	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Participants available for this outcome measure at given time period were included for assessment.

IBDQ was a 32-item questionnaire that measured 4 dimensions: bowel systems, emotional health, systemic systems, 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.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 Bowel systems	5.64 score on scale Standard Deviation 1.18	5.73 score on scale Standard Deviation 1.10	—	—
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 Emotional health	5.21 score on scale Standard Deviation 1.40	5.38 score on scale Standard Deviation 1.25	—	—
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 Systemic systems	5.15 score on scale Standard Deviation 1.16	5.15 score on scale Standard Deviation 1.21	—	—
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 Social function	6.02 score on scale Standard Deviation 1.40	5.96 score on scale Standard Deviation 1.32	—	—

SECONDARY outcome

Timeframe: Day 1

WPAI assessed impact of IBD on work productivity and daily activities in past 7 days. WPAI questions were: if currently employed, 2) hours (hrs) missed due to disease, 3) hrs missed other reasons, 4) hrs actually worked, 5) degree disease affected productivity while working, 6) degree disease affected regular activities. WPAI generates 4 component scores: percentage (%) of work time missed (absenteeism), % of impairment while working (presenteeism), % of overall work impairment (absenteeism and presenteeism combined), and % of activity impairment. TWPI was calculated based on 3 items: (Q2) number of hrs missed from work due to health problems in the past 7 days; (Q4) number of actual work hrs in past 7 days; and (Q5) to what degree did disease impair productivity while working in past 7 days. Data was calculated by: Q2/(Q2+Q4)+(\[1-(Q2/\[Q2+Q4\])\*(Q5/10\])\*100 (converted to %). Data is presented as impairment percentage, with higher numbers indicating greater impairment/less productivity.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=58 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=81 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Mean of Percentage of Total Work Productivity Impairment (TWPI) Due to CD or UC as Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI)	98.83 Percentage of TWPI Standard Deviation 3.27	98.79 Percentage of TWPI Standard Deviation 4.06	—	—

SECONDARY outcome

Timeframe: Day 1

WPAI assessed impact of IBD on work productivity and daily activities in past 7 days. WPAI questions were: if currently employed, 2) hours missed due to disease, 3) hours missed other reasons, 4) hours actually worked, 5) degree disease affected productivity while working, 6) degree disease affected regular activities. WPAI generates 4 component scores: percentage of work time missed (absenteeism), percentage of impairment while working (presenteeism), percentage of overall work impairment (absenteeism and presenteeism combined), and percentage of activity impairment. Work time missed was calculated based on 2 items: (Q2) number of hours missed from work due to health problems in the past 7 days; and (Q4) number of actual work hours in past 7 days. Data was calculated by following formula:Q2/(Q2+Q4)\*100 (converted to %), where higher numbers indicated greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=62 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=85 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Mean of Percentage of Work Time Missed Due to CD or UC as Assessed by WPAI at Day 1	9.65 percentage of work time missed Standard Deviation 25.38	7.81 percentage of work time missed Standard Deviation 22.45	—	—

SECONDARY outcome

Timeframe: Day 1

WPAI assessed impact of IBD on work productivity and daily activities in past 7 days. WPAI questions were: if currently employed, 2) hours missed due to disease, 3) hours missed other reasons, 4) hours actually worked, 5) degree disease affected productivity while working, 6) degree disease affected regular activities. WPAI generates 4 component scores: percentage of work time missed (absenteeism), percentage of impairment while working (presenteeism), percentage of overall work impairment (absenteeism and presenteeism combined), and percentage of activity impairment. Percentage of impairment while working was calculated based on 1 item: (Q5) to what degree did disease impair productivity while working in past 7 days. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). Data was calculated by following formula: Q5/10\*100 (converted to percent), where higher numbers indicated greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=58 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=82 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Mean of Percentage of Impairment While Working Due to CD or UC as Assessed by WPAI at Day 1	10.86 percentage of impairment while working Standard Deviation 19.04	11.95 percentage of impairment while working Standard Deviation 18.08	—	—

SECONDARY outcome

Timeframe: Day 1

WPAI assessed impact of IBD on work productivity and daily activities in past 7 days. WPAI questions were: if currently employed, 2) hours (hrs) missed due to disease, 3) hrs missed other reasons, 4) hrs actually worked, 5) degree disease affected productivity while working, 6) degree disease affected regular activities. WPAI generates 4 component scores: percentage (%) of work time missed (absenteeism), % of impairment while working (presenteeism), % of overall work impairment (absenteeism and presenteeism combined), and % of activity impairment. % of total activity impairment was calculated based on: (Q6) in past 7 days, how much did your health problems affect your ability to do your regular daily activities, other than work at a job. Item was measured on scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). Data was calculated by: Q6/10\*100 (converted to percent), where higher numbers indicated greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Mean of Percentage of Total Activity Impairment Due to CD or UC as Assessed by WPAI at Day 1	21.49 percentage of activity impairment Standard Deviation 28.09	22.62 percentage of activity impairment Standard Deviation 27.81	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Due to change in planned analysis, data was not collected and analyzed. Percentage of participants who quit job due to IBD and have not been able to return to work was not calculated since this variable was not captured in case report form.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within previous 3 years including Day 1

Healthcare resources included drug therapies, imaging and laboratory testing, surgeries, hospitalizations and consultations.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=101 Participants Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis n=145 Participants Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (Moderate to Severe) Participants diagnosed with moderate to severe UC (9-point pMayo score \>=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.	Ulcerative Colitis (no or Mild) Participants diagnosed with no or mild UC (9-point pMayo score \<5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Number of Participants With Moderate to Severe CD or UC Who Used Healthcare Resources Over the Previous 3 Years Previous imaging and laboratory	100 participants	141 participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Healthcare Resources Over the Previous 3 Years Previous surgeries	18 participants	2 participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Healthcare Resources Over the Previous 3 Years Previous hospitalization	34 participants	31 participants	—	—
Number of Participants With Moderate to Severe CD or UC Who Used Healthcare Resources Over the Previous 3 Years Previous consultation	98 participants	138 participants	—	—

Adverse Events

Crohn's Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 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