Trial Outcomes & Findings for A Study of Moderate to Severe Inflammatory Bowel Disease, Including Ulcerative Colitis (UC) and Crohn's Disease (CD) (NCT NCT04873700)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

335 participants

Primary outcome timeframe

Day 1

Results posted on

2024-11-07

Participant Flow

Participants took part in the study at approximately 12 investigative sites in Mexico from 30 August 2021 to 17 May 2022.

Participants with mild to none and moderate to severe inflammatory bowel disease (Ulcerative Colitis or Crohn's Disease) were enrolled in this retrospective observational study. 335 participants were enrolled, but 9 participants had insufficient data to define level of disease activity and they were not included in the analysis. All analysis and comparisons were performed considering 326 participants.

Participant milestones

Participant milestones
Measure	Moderate to Severe Crohn's Disease Participants diagnosed with moderate to severe CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis Participants diagnosed with moderate to severe UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Overall Study STARTED	43	52	42	189
Overall Study COMPLETED	43	52	42	189
Overall Study NOT COMPLETED	0	0	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	Moderate to Severe Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Total n=326 Participants Total of all reporting groups
Age, Continuous	49.5 years n=43 Participants	42.8 years n=52 Participants	43.0 years n=42 Participants	43.4 years n=189 Participants	44.67 years n=326 Participants
Sex: Female, Male Female	25 Participants n=43 Participants	33 Participants n=52 Participants	19 Participants n=42 Participants	114 Participants n=189 Participants	191 Participants n=326 Participants
Sex: Female, Male Male	18 Participants n=43 Participants	19 Participants n=52 Participants	23 Participants n=42 Participants	75 Participants n=189 Participants	135 Participants n=326 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Mexico	43 Participants n=43 Participants	52 Participants n=52 Participants	42 Participants n=42 Participants	189 Participants n=189 Participants	326 Participants n=326 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data is reported for participants with active CD.

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

Outcome measures

Outcome measures
Measure	Crohn's Disease n=95 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Percentage of Participants With Active CD at Day 1	45.3 percentage of participants Interval 35.3 to 55.3	—	—	—

PRIMARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data is reported for participants with active UC.

Percentage of participants with active disease UC disease will be observed, where UC is defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score is composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0 to 2), having mild activity (pMayo of 3 or 4) or moderate to severe activity (pMayo of \>=5).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=231 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Percentage of Participants With Active UC at Day 1	18.2 percentage of participants Interval 13.2 to 23.2	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data is reported for participants with CD only. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants with data available for each category of the clinical presentation.

Number of participants will be reported based on the clinical presentations (location, behavior, perianal disease, achievement of ileal disease and extraintestinal manifestations for CD participants). Clinical presentations that have data for at least one participant in the below categories are reported. Data is reported for participants with CD only.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=7 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=30 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Number of Participants With CD Based on Clinical Presentation Location: Ileal(L1)	0 Participants	9 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Location: L1+Isolated Upper GI Tract Disease(L4)	0 Participants	1 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Location: Colonic Disease (L2)	1 Participants	5 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Location: L2 + L4	1 Participants	0 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Location: Ileocolic(L3)	4 Participants	11 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Behavior: Non stenosing/non penetrating	0 Participants	10 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Behavior: Stenosing (B2)	5 Participants	12 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Behavior: B2+Perianal Disease (P)	0 Participants	2 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Behavior: Penetrating (B3)	1 Participants	1 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Behavior: B3+P	0 Participants	1 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Perianal Disease: None	4 Participants	23 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Perianal Disease: Indolent Fistula	0 Participants	3 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Perianal Disease: Active Fistula	1 Participants	0 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Perianal Disease: Hemorrhoids	1 Participants	0 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Ileal Disease: Achievement ≥1	3 Participants	19 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Ileal Disease: Achievement <1	3 Participants	3 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Extraintestinal Manifestations: Peripheral arthritis	3 Participants	4 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Extraintestinal Manifestations: Aphthous ulcers	0 Participants	2 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Extraintestinal Manifestations: Episcleritis	0 Participants	1 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Extraintestinal Manifestations: Uveitis	1 Participants	1 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Extraintestinal Manifestations: Osteoporosis	0 Participants	1 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Extraintestinal Manifestations: Anemia	2 Participants	0 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Extraintestinal Manifestations: Hematological alteration	0 Participants	1 Participants	—	—
Number of Participants With CD Based on Clinical Presentation Extraintestinal Manifestations: Other	1 Participants	20 Participants	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data is reported for participants with UC only. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants with data available for each category of the clinical presentation.

Number of participants will be reported based on the clinical presentations (location, behavior, and extraintestinal manifestations,). Clinical presentations that have data for at least one participant in the below categories are reported. Data is reported for participants with UC only.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=14 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=103 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Number of Participants With UC Based on Clinical Presentation Location - Distal UC: Proctitis(E1)	2 Participants	10 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Location - Distal UC: Proctosigmoiditis(E1)	3 Participants	14 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Location - Left sided: Mucosa inflammation extending up to splenic flexure(E2)	5 Participants	22 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Location - Pancolitis: Mucosa inflammation up to proximal transverse colon and beyond(E3)	4 Participants	52 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Behavior - clinical remission (asymptomatic)(S0)	0 Participants	43 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Behavior - mild UC(S1)	5 Participants	34 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Behavior - moderate UC(S2)	8 Participants	18 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Behavior - severe UC(S3)	1 Participants	3 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Extraintestinal manifestations - Peripheral arthritis	1 Participants	23 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Extraintestinal manifestations - Pyoderma gangrenosum	0 Participants	2 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Extraintestinal manifestations - Aphthous ulcers	0 Participants	1 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Extraintestinal manifestations - Primary sclerosing cholangitis	0 Participants	1 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Extraintestinal manifestations - Osteoporosis	0 Participants	2 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Extraintestinal manifestations - Anemia	3 Participants	3 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Extraintestinal manifestations - Hematological alteration	0 Participants	1 Participants	—	—
Number of Participants With UC Based on Clinical Presentation Extraintestinal manifestations - Other	10 Participants	70 Participants	—	—

SECONDARY outcome

Timeframe: From 3 years prior to Day 1 until Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.

Number of participants will be reported based on the IBD therapies which include aminosalicylates, steroids, immunomodulators, immunosuppressants, biologics, antibiotics, probiotics, and surgeries. A participant can receive more than one IDB therapy.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Sulfasalazine (SSZ)	1 Participants	1 Participants	6 Participants	14 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Mesalazine (5-ASA)	20 Participants	25 Participants	36 Participants	140 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Olsalazine	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Mesalazine extended release	2 Participants	3 Participants	5 Participants	52 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Hydrocortisone	4 Participants	3 Participants	5 Participants	17 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Prednisone	18 Participants	23 Participants	19 Participants	77 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Prednisolone	0 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Budesonide	5 Participants	9 Participants	7 Participants	42 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Methylprednisolone	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Azathioprine	14 Participants	19 Participants	12 Participants	81 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies 6-mercaptopurine	0 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Methotrexate	4 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Infliximab	13 Participants	9 Participants	9 Participants	46 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Adalimumab	21 Participants	22 Participants	4 Participants	26 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Vedolizumab	1 Participants	1 Participants	4 Participants	9 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Certolizumab	4 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Golimumab	0 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Ustekinumab	13 Participants	8 Participants	2 Participants	1 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Metronidazole	3 Participants	0 Participants	2 Participants	4 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Ciprofloxacin	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Other	14 Participants	3 Participants	11 Participants	44 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Salicylic derivatives + Immunosuppressants	10 Participants	19 Participants	27 Participants	122 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Biologic therapy + Immunosuppressants	12 Participants	14 Participants	1 Participants	4 Participants
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies Salicylic derivatives + Immunosuppressants + Biologic therapy	19 Participants	18 Participants	13 Participants	60 Participants

SECONDARY outcome

Timeframe: From 3 years prior to Day 1 until Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria. Number analyzed is the number of participants who had a complete duration from start to end date of therapy. Participants with incomplete or missing dates were not included in the analysis.

Time between the beginning of IBD therapy until the end of treatment or Day 1, whichever comes first. IBD therapies include aminosalicylates, steroids, immunomodulators, immunosuppressants, biologics, antibiotics, probiotics, and surgeries.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Duration of IBD Therapies Sulfasalazine (SSZ)	0.2 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	—	33.3 months Interval 17.0 to 42.0	62.3 months Interval 40.3 to 84.3
Duration of IBD Therapies Mesalazine (5-ASA)	42.1 months Interval 3.7 to 111.1	34.3 months Interval 18.6 to 50.0	8.4 months Interval 0.2 to 347.2	54.3 months Interval 0.6 to 138.1
Duration of IBD Therapies Mesalazine Extended release	31.0 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	—	—	—
Duration of IBD Therapies Olsalazine	—	—	60.0 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	—
Duration of IBD Therapies Hydrocortisone	0.1 months Interval 0.1 to 0.13	0.1 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	0.2 months Interval 0.2 to 0.3	0.1 months Interval 0.0 to 0.3
Duration of IBD Therapies Prednisone	5.0 months Interval 0.9 to 207.4	2.9 months Interval 1.1 to 83.9	1.6 months Interval 0.7 to 182.0	3.0 months Interval 0.1 to 148.5
Duration of IBD Therapies Prednisolone	—	—	—	3.2 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.
Duration of IBD Therapies Budesonide	—	—	2.0 months Interval 1.3 to 12.4	2.8 months Interval 1.4 to 18.0
Duration of IBD Therapies Azathioprine	40.3 months Interval 2.7 to 111.1	38.6 months Interval 4.1 to 96.31	1.5 months Interval 0.06 to 153.5	45.5 months Interval 0.2 to 181.8
Duration of IBD Therapies Methotrexate	4.9 months Interval 3.8 to 6.0	—	0.7 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	—
Duration of IBD Therapies Metronidazole	0.2 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	—	0.2 months Interval 0.2 to 0.2	0.2 months Interval 0.2 to 0.3
Duration of IBD Therapies Ciprofloxacin	—	—	0.2 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	—
Duration of IBD Therapies Infliximab	10.3 months Interval 0.8 to 17.0	62.3 months Interval 5.5 to 89.8	21.9 months Interval 3.1 to 73.4	14.2 months Interval 0.75 to 181.4
Duration of IBD Therapies Adalimumab	27.5 months Interval 0.19 to 125.2	34.27 months Interval 5.3 to 103.8	28.6 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	27.5 months Interval 0.1 to 125.2
Duration of IBD Therapies Vedolizumab	—	—	—	9.0 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.
Duration of IBD Therapies Ustekimumab	66.5 months Interval 50.4 to 82.6	1.0 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	—	—
Duration of IBD Therapies Certolizumab	15.7 months Interval 3.9 to 132.0	—	—	—
Duration of IBD Therapies Golimumab	—	—	0.3 months Minimum and Maximum range was not estimable due to insufficient number of participants with events.	—
Duration of IBD Therapies Other:	23.8 months Interval 0.2 to 47.4	—	2.8 months Interval 0.1 to 128.2	4.5 months Interval 0.1 to 103.7

SECONDARY outcome

Timeframe: From 3 years prior to Day 1 until Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria.

Percentage of participants who have experienced any biologic therapy (examples, infliximab, adalimumab, golimumab, ustekinumab, certolizumab) once or more than once according to medical history until the day 1. Percentages are rounded off to the nearest single decimal.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Percentage of Participants With UC or CD Based on Biologic-experience	72.0 percentage of participants	61.5 percentage of participants	33.0 percentage of participants	33.8 percentage of participants

SECONDARY outcome

Timeframe: From 3 years prior to Day 1 until Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria.

Percentages are rounded off to the nearest single decimal.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies	65.1 percentage of participants	25.0 percentage of participants	28.5 percentage of participants	20.1 percentage of participants

SECONDARY outcome

Timeframe: From 3 years prior to Day 1 until Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria.

Percentages are rounded off to the nearest single decimal.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Poor effectiveness	34.8 percentage of participants	15.3 percentage of participants	11.9 percentage of participants	9.5 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Patient decision	6.9 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Remission	0 percentage of participants	0 percentage of participants	0 percentage of participants	1.0 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Unknown	0 percentage of participants	0 percentage of participants	4.7 percentage of participants	2.1 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Patient poor adherence	2.3 percentage of participants	3.8 percentage of participants	0 percentage of participants	1.0 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Comorbidity	0 percentage of participants	0 percentage of participants	0 percentage of participants	0.5 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Adverse reaction	4.6 percentage of participants	0 percentage of participants	0 percentage of participants	3.7 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Patient access to treatment	6.9 percentage of participants	0 percentage of participants	0 percentage of participants	0.5 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Antibodies	2.3 percentage of participants	1.9 percentage of participants	0 percentage of participants	0.5 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Serum level of antidrug	0 percentage of participants	1.9 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies Other	6.9 percentage of participants	1.9 percentage of participants	11.9 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria.

The IBD treatment categories that have data for at least one participant are reported.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Adalimumab	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Sulfasalazine (SSZ)	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Mesalazine (5-ASA)	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Mesalazine extended release	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Prednisone	0 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Budesonide	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Azathioprine	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Infliximab	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Vedolizumab	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Ustekinumab	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Metronidazole	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Ciprofloxacin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 Other	1 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data for participants with CD were reported.

CDAI assessed clinical signs and symptoms: number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0-600 points. Higher score indicates more severe disease. HBI score measures disease activity of CD based on 5 clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicate more severe disease. Socio-demographic variables included age, sex, professional status, educational level, participant income. Clinical variables included duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and EIM.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=95 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Number of Participants With HBI >=8 or CDAI >=220 Points Versus HBI <8 or CDAI <220 Points Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in CD Participants	43 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data for participants with UC were reported.

Mayo score is composed of 4 categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0-2), having mild activity (pMayo of 3-4) or moderate to severe activity (pMayo \>=5). Socio-demographic variables included age, sex, professional status, educational level, participant income. Clinical variables included duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and extraintestinal manifestations (EIM).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=231 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants	42 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants available for analysis for specified categories.

SF-36 is a general quality of life (QoL)-questionnaire, which evaluates 8 health dimensions: physical functioning, bodily pain, role physical (limitations due to physical problems), role emotional (limitations due to personal or emotional problems), mental health, social functioning, vitality, and general health perceptions. Based on these 8 dimensions, two weighted scores were generated: the physical component summary (PCS) score and the mental component summary (MCS) score. Scores range between 0 and 100, with higher scores indicating a better quality of life. Mean score of each component (physical component and mental component) was reported.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=188 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants General Health	43.4 score on a scale Standard Deviation 20.64	48.0 score on a scale Standard Deviation 23.59	43.4 score on a scale Standard Deviation 22.26	53.6 score on a scale Standard Deviation 23.62
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants Physical Functioning	64.2 score on a scale Standard Deviation 28.43	77.5 score on a scale Standard Deviation 24.10	71.1 score on a scale Standard Deviation 25.89	81.1 score on a scale Standard Deviation 22.97
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants Bodily Pain	52.7 score on a scale Standard Deviation 28.12	65.0 score on a scale Standard Deviation 27.90	57.5 score on a scale Standard Deviation 29.36	70.6 score on a scale Standard Deviation 26.09
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants Role Physical	55.5 score on a scale Standard Deviation 28.87	62.9 score on a scale Standard Deviation 28.29	51.8 score on a scale Standard Deviation 26.63	69.9 score on a scale Standard Deviation 25.43
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants Role Emotional	55.6 score on a scale Standard Deviation 28.51	62.2 score on a scale Standard Deviation 26.89	57.1 score on a scale Standard Deviation 28.07	70.6 score on a scale Standard Deviation 24.04
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants Mental Health	56.6 score on a scale Standard Deviation 20.43	60.9 score on a scale Standard Deviation 19.82	56.5 score on a scale Standard Deviation 22.62	64.8 score on a scale Standard Deviation 19.39
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants Social Functioning	53.8 score on a scale Standard Deviation 29.19	66.6 score on a scale Standard Deviation 25.09	59.2 score on a scale Standard Deviation 28.70	69.7 score on a scale Standard Deviation 26.81
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants Vitality	43.9 score on a scale Standard Deviation 20.30	53.7 score on a scale Standard Deviation 21.23	49.4 score on a scale Standard Deviation 22.55	57.2 score on a scale Standard Deviation 20.56

SECONDARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.

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=42 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=51 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=188 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants	144.8 score on a scale Standard Deviation 42.78	159.03 score on a scale Standard Deviation 36.00	140.2 score on a scale Standard Deviation 43.67	165.7 score on a scale Standard Deviation 33.85

SECONDARY outcome

Timeframe: The last 7 days prior to Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of employed participants with data available for analysis for this outcome measure.

WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean total percentage of work impairment (absenteeism and presentisms) were reported in terms of hours.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=26 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=28 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=21 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=115 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants	20.337 Percentage of total work impairment Standard Deviation 19.2252	21.184 Percentage of total work impairment Standard Deviation 21.4860	24.152 Percentage of total work impairment Standard Deviation 15.6386	17.700 Percentage of total work impairment Standard Deviation 19.6796

SECONDARY outcome

Timeframe: The last 7 days prior to Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of employed participants with data available for analysis for this outcome measure.

WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean work time missed (absenteeism) was reported.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=26 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=28 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=21 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=118 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants	19.873 percentage of work time missed Standard Deviation 30.6995	17.285 percentage of work time missed Standard Deviation 25.1336	9.798 percentage of work time missed Standard Deviation 16.3332	10.590 percentage of work time missed Standard Deviation 23.7578

SECONDARY outcome

Timeframe: The last 7 days prior to Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of employed participants with data available for analysis for this outcome measure.

WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean impairment while working (presentisms) was reported.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=27 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=30 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=21 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=116 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants	33.3 Percentage of Impairment Standard Deviation 33.85	30.0 Percentage of Impairment Standard Deviation 30.40	29.5 Percentage of Impairment Standard Deviation 22.69	23.1 Percentage of Impairment Standard Deviation 25.92

SECONDARY outcome

Timeframe: The last 7 days prior to Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of employed participants with data available for analysis for this outcome measure.

WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants only answered to questions related to employment status and regular activities impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Mean total activity impairment was reported.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=26 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=28 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=21 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=115 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants	45.7 percentage of total activity impairment Standard Deviation 35.87	33.1 percentage of total activity impairment Standard Deviation 30.76	44.0 percentage of total activity impairment Standard Deviation 30.45	27.4 percentage of total activity impairment Standard Deviation 29.53

SECONDARY outcome

Timeframe: Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.

Percentages are rounded off at the nearest single decimal.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work	0 percentage of participants	0 percentage of participants	4.8 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From 3 years prior to Day 1 until Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.

Healthcare resources included hospitalizations, medical appointments, imaging, and laboratory testing. Percentages are rounded off to whole number at the nearest decimal.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Percentage of Participants With UC or CD Categorized Based on Healthcare Resources Imaging and Laboratory Testing	60.5 percentage of participants	61.5 percentage of participants	52.4 percentage of participants	67.2 percentage of participants
Percentage of Participants With UC or CD Categorized Based on Healthcare Resources Hospital Admissions	37.2 percentage of participants	17.3 percentage of participants	28.6 percentage of participants	12.7 percentage of participants
Percentage of Participants With UC or CD Categorized Based on Healthcare Resources Medical Appointments: IBD Specialist	67.4 percentage of participants	59.6 percentage of participants	64.3 percentage of participants	66.7 percentage of participants
Percentage of Participants With UC or CD Categorized Based on Healthcare Resources Medical Appointments: Emergency Medical Appointment	2.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With UC or CD Categorized Based on Healthcare Resources Medical Appointments: Other Specialist	4.7 percentage of participants	0 percentage of participants	2.4 percentage of participants	4.2 percentage of participants

SECONDARY outcome

Timeframe: From 3 years prior to Day 1 until Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.

A cost analysis of Ulcerative Colitis (UC) and Crohn's Disease (CD) was developed, classified by severity as mild and moderate-severe for each of the conditions. Direct medical costs were considered and included the following items: associated comorbidities, intestinal manifestations, surgical procedures, emergency visits, hospitalizations, medical appointments, follow-up studies, and previous pharmacological treatments; this was collected in the study including the number of participants and the proportion of them that presented the items studied. The total direct medical cost for all participants with each of the conditions was obtained, with the average 3-year cost per participant for UC and for CD multiplied by the number of all participants with UC and CD respectively. So, the values reported in the data table below represent the total direct cost for all participants with UC and CD respectively. The total direct cost was in Mexican Peso(MXN).

Outcome measures

Outcome measures
Measure	Crohn's Disease n=43 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=52 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=42 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=189 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Total Direct Medical Cost for Participants With UC or CD	16362506.13 MXN	12611636.50 MXN	9673667.75 MXN	33842289.53 MXN

SECONDARY outcome

Timeframe: From 3 years prior to Day 1 until Day 1

Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number of participants analyzed is the number of employed participants.

A cost analysis of UC and CD was developed, classified by severity as mild and moderate-severe for each condition. Indirect cost was estimated by using number of hours missed from work (absenteeism) multiplied by average hourly labor cost including wages and benefits, to calculate average lost productivity cost per participant due to absenteeism during specified duration. Hours missed from work were assessed by Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answered 6 questions related to work productivity and impairment.The indirect medical cost for all participants with each of the conditions was obtained,with the average 3-year cost per participant for UC and for CD multiplied by the number of all employed participants with UC and CD respectively. So, values reported in data table below represent the indirect cost in totality for all employed participants with UC and CD respectively. The indirect cost is in MXN.

Outcome measures

Outcome measures
Measure	Crohn's Disease n=27 Participants Participants diagnosed with moderate to severe Crohn's Disease (CD) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD.	Mild to None Crohn's Disease n=30 Participants Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.	Moderate to Severe Ulcerative Colitis n=21 Participants Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.	Mild to None Ulcerative Colitis n=120 Participants Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Indirect Cost for Participants With UC or CD	394402.91 MXN	276419.13 MXN	77869.29 MXN	458451.24 MXN

Adverse Events

Moderate to Severe Crohn's Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild to None Crohn's Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate to Severe Ulcerative Colitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild to None 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

Study 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