Triple Combination Therapy in High Risk Crohn's Disease (CD) | NCT02764762

ID	Type	Description	Link
U1111-1175-9094	Registry Identifier	WHO

Label	Type	Description	Intervention Names
Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Experimental	In Triple Combination Therapy Phase, vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg subcutaneously (SC), once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34. In Monotherapy Phase, vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.	Drug: Vedolizumab Drug: Adalimumab Drug: Methotrexate

Name	Type	Description	Arm Group Labels	Other Names
Vedolizumab	Drug	Vedolizumab intravenous infusion.	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)

Measure	Description	Time Frame
Percentage of Participants Achieving Endoscopic Remission at Week 26	Endoscopic remission was defined as simple endoscopic score for Crohn's Disease (SES-CD) scale score from 0-2. The SES-CD evaluated 4 endoscopic variables: ulcer size, proportion of the surface area that was ulcerated, proportion of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.	Week 26

Measure	Description	Time Frame
Percentage of Participants Achieving Endoscopic Healing at Week 26	Endoscopic healing was defined as SES-CD score ≤4 and reduction from Baseline in SES-CD score of at least 2 points and no individual SES-CD subscore >1. The SES-CD evaluated 4 endoscopic variables: ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Percentages are rounded off to single decimal.

Name	Affiliation	Role
Medical Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Health Specialists of the Southeast		Dothan	Alabama	36305	United States
Gastro Florida

PubMed Identifier	Type	Citation	Retractions
37743037	Derived	Colombel JF, Ungaro RC, Sands BE, Siegel CA, Wolf DC, Valentine JF, Feagan BG, Neustifter B, Kadali H, Nazarey P, James A, Jairath V, Qasim Khan RM. Vedolizumab, Adalimumab, and Methotrexate Combination Therapy in Crohn's Disease (EXPLORER). Clin Gastroenterol Hepatol. 2024 Jul;22(7):1487-1496.e12. doi: 10.1016/j.cgh.2023.09.010. Epub 2023 Sep 22.

ID	Title	Description
FG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 milligram (mg), intravenous (IV) infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg subcutaneously (SC), once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34. Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 30, 2020	Sep 22, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Achieving Endoscopic Remission at Week 26

Endoscopic remission was defined as simple endoscopic score for Crohn's Disease (SES-CD) scale score from 0-2. The SES-CD evaluated 4 endoscopic variables: ulcer size, proportion of the surface area that was ulcerated, proportion of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

Full Analysis Set (FAS) included all participants who received at least 1 dose of study medication and have a post-enrollment efficacy assessment. As pre-specified in the protocol, this outcome measure reports data only in the Triple Combination Therapy Phase at Week 26.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Units	Counts
Participants	OG00055

Title

Denominators

Categories

Title	Measurements
	OG00034.5(21.1 to 48.0)

Secondary

Percentage of Participants Achieving Endoscopic Healing at Week 26

Endoscopic healing was defined as SES-CD score ≤4 and reduction from Baseline in SES-CD score of at least 2 points and no individual SES-CD subscore >1. The SES-CD evaluated 4 endoscopic variables: ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Percentages are rounded off to single decimal.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Units	Counts

Secondary

Percentage of Participants Achieving Endoscopic Response at Week 26

Endoscopic response was defined as 50% reduction in SES-CD score from Baseline. The SES-CD evaluated 4 endoscopic variables: ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Percentages are rounded off to single decimal.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Units	Counts
Participants

Secondary

Change From Baseline in SES-CD Score at Week 26

The SES-CD evaluated 4 endoscopic variables: ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Negative change indicates improvement.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment. Number analyzed indicates the number of participants available for analysis at the given timepoint.

Posted

Mean

Standard Deviation

score on a scale

Baseline and Week 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving Deep Remission at Week 26

Deep remission was defined as Crohn's disease activity index (CDAI) score <150 and SES-CD score from 0-2. CDAI was scoring system for the assessment of CD activity, index values of 150 and below were associated with quiescent disease; values above that indicated active disease and values above 450 were seen with extremely severe disease. The SES-CD evaluated 4 endoscopic variables: ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was sum of values obtained for each segment. The SES-CD total was sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Percentages are rounded off to single decimal.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Secondary

Percentage of Participants Achieving Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 26

Clinical remission was defined as CDAI score <150. Endoscopic response was defined as 50% reduction in SES-CD score from Baseline, as mucosal healing. CDAI was scoring system for assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicated active disease and values above 450 were seen with extremely severe disease. The SES-CD evaluated 4 endoscopic variables: ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total was sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Percentages are rounded off to single decimal.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Secondary

Percentage of Participants Achieving Clinical Remission at Weeks 10 and 26

Clinical remission was defined as CDAI score <150. CDAI was scoring system for the assessment of CD activity, index values of 150 and below were associated with quiescent disease; values above that indicated active disease and values above 450 were seen with extremely severe disease. Percentages are rounded off to single decimal.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Weeks 10 and 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Clinical Response at Weeks 10 and 26

Clinical response was defined as ≥100-point decrease in CDAI score. CDAI was scoring system for the assessment of CD activity, index values of 150 and below were associated with quiescent disease; values above that indicated active disease and values above 450 were seen with extremely severe disease. Percentages are rounded off to single decimal.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Weeks 10 and 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26

The change between the CRP levels were collected at Weeks 10 and 26 relative to Baseline. Negative change indicates improvement.

Posted

Median

Full Range

milligrams per liter (mg/L)

Baseline, Weeks 10 and 26

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102

The change between the fecal calprotectin concentrations collected at Weeks 10, 14, 26, 52, 78, and 102 relative to Baseline were reported. Baseline is defined as the last observation prior to the first dose of the study drug.

Posted

Median

Full Range

micrograms per gram

Baseline, Weeks 10, 14, 26, 52, 78 and 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.
OG001	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Secondary

Percentage of Participants Achieving Clinical Remission and CRP <5 Milligram Per Liter (mg/L) at Weeks 26, 52, 78, and 102

Clinical remission was defined as CDAI score <150 and CRP level <5 mg/L in participants with elevated CRP level at Baseline. CDAI was scoring system for the assessment of CD activity, index values of 150 and below were associated with quiescent disease; values above that indicate active disease and values above 450 were seen with extremely severe disease. Percentages are rounded off to single decimal.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment. Overall number of participants analyzed are the number of participants with Elevated CRP at Baseline. Number analyzed indicates the number of participants available for analysis at the given timepoint.

Posted

Number

95% Confidence Interval

percentage of participants

Weeks 26, 52, 78 and 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.
OG001	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Secondary

Percentage of Participants Using Oral Corticosteroids at Baseline Who Have Discontinued Corticosteroids and Are in Clinical Remission at Weeks 10, 26, and 102

Percentage of participants using oral corticosteroids at Baseline who had discontinued corticosteroids and were in clinical remission at weeks 10, 26, and 102 were reported. Clinical remission was defined as CDAI score <150. CDAI was scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 were seen with extremely severe disease. Percentages are rounded off to single decimal.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment. Overall number of participants analyzed are the number of participants with Baseline concomitant oral corticosteroid use. Number analyzed indicates the number of participants available for analysis at the given timepoint.

Posted

Number

95% Confidence Interval

percentage of participants

Weeks 10, 26 and 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.
OG001

Secondary

Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102

Clinical remission was defined as CDAI score <150. Clinical remission was defined as CDAI score <150. CDAI was scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicated active disease and values above 450 were seen with extremely severe disease. Percentages are rounded off to single decimal.

Posted

Number

95% Confidence Interval

percentage of participants

Weeks 52, 78 and 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Maintaining Clinical Response at Weeks 52, 78, and 102

Posted

Number

95% Confidence Interval

percentage of participants

Weeks 52, 78 and 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Maintaining Endoscopic Remission at Week 102

Endoscopic remission was defined as SES-CD score 0-2. The SES-CD evaluated 4 endoscopic variables: ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicated more severe disease. Percentages are rounded off to single decimal.

Posted

Number

95% Confidence Interval

percentage of participants

Week 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Units	Counts
Participants

Secondary

Percentage of Participants Maintaining Deep Remission at Week 102

Deep remission was defined as CDAI score <150 and SES-CD score 0-2. Clinical remission was defined as CDAI score <150. CDAI was scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicated active disease and values above 450 were seen with extremely severe disease. The SES-CD evaluated 4 endoscopic variables: ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Percentages are rounded off to single decimal.

Posted

Number

95% Confidence Interval

percentage of participants

Week 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Units	Counts

Secondary

Percentage of Participants Maintaining Endoscopic Healing at Week 102

Endoscopic healing was defined as SES-CD score <=4 and reduction from Baseline in SES-CD score of at least 2 points and no individual SES-CD subscore >1. The SES-CD evaluated 4 endoscopic variables: ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Percentages are rounded off to single decimal.

Posted

Number

94% Confidence Interval

percentage of participants

Week 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Units	Counts
Participants

Secondary

Percentage of Participants Maintaining Endoscopic Response at Week 102

Posted

Number

95% Confidence Interval

percentage of participants

Week 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Units	Counts
Participants

Secondary

Percentage of Participants Maintaining Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 102

Clinical remission is defined as CDAI score <150. Endoscopic response defined as 50% reduction in SES-CD score from Baseline, as mucosal healing. CDAI is scoring system for assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Percentages are rounded off to the nearest decimal value.

FAS included all participants who received at least 1 dose of study medication and had a post-enrollment efficacy assessment. Overall number of participants analyzed are the number of participants with clinical remission and endoscopic response at Week 26.

Posted

Number

95% Confidence Interval

percentage of participants

Week 102

ID	Title	Description
OG000	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Secondary

Percentage of Participants With First Exacerbation of CD

First exacerbation of CD after 26 weeks was defined as either: 1) a CDAI increase of >70 from the prior visit on 2 occasions separated by a 2-week interval, objective evidence of disease activity by colonoscopy or CRP above normal OR 2) fecal calprotectin >250 microgram per gram (mcg/g) alone. CDAI was scoring system for the assessment of CD activity, index values of 150 and below were associated with quiescent disease; values above that indicated active disease and values above 450 are seen with extremely severe disease. Percentages are rounded off to the nearest decimal value.

Posted

Number

95% Confidence Interval

percentage of participants

After 26 Weeks up to Week 120

ID	Title	Description
OG000	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

Units	Counts
Participants

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)	Participants received triple combination therapy of vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg SC, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.	55	6	55	36	55
EG001	Vedolizumab 300 mg (IV)	Following the triple combination treatment participants received monotherapy of vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.	45	1	45	31	45
EG002	Safety Follow-up	Participants who completed the study treatment or were terminated early from the study were followed-up for safety up to 18 weeks after receiving the last dose of study drug.	53	2	53	4	53

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal wall abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected55 at risk EG0010 affected45 at risk EG0021 affected53 at risk
Appendicitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected55 at risk EG0011 affected45 at risk EG0020 affected53 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected55 at risk EG0010 affected45 at risk EG0021 affected53 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected55 at risk EG0010 affected45 at risk EG0020 affected53 at risk
Gastroenteritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected55 at risk EG0010 affected45 at risk EG0020 affected53 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected55 at risk EG0010 affected45 at risk EG0020 affected53 at risk
Perirectal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected55 at risk EG0010 affected45 at risk EG0020 affected53 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected55 at risk EG0010 affected45 at risk EG0020 affected53 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected55 at risk EG0010 affected45 at risk EG0021 affected53 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected55 at risk EG0014 affected45 at risk EG0020 affected53 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected55 at risk EG0011 affected45 at risk EG0020 affected53 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected55 at risk EG0013 affected45 at risk EG0020 affected53 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG00010 affected55 at risk EG0013 affected45 at risk EG0020 affected53 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 affected55 at risk EG0012 affected45 at risk EG0020 affected53 at risk
C-reactive protein increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected55 at risk EG0014 affected45 at risk EG0020 affected53 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected55 at risk EG0014 affected45 at risk EG0020 affected53 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0009 affected55 at risk EG00120 affected45 at risk EG0024 affected53 at risk
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected55 at risk EG0013 affected45 at risk EG0020 affected53 at risk
Faecal calprotectin increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 affected55 at risk EG0014 affected45 at risk EG0020 affected53 at risk
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected55 at risk EG0011 affected45 at risk EG0020 affected53 at risk
Gastroenteritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 affected55 at risk EG0010 affected45 at risk EG0020 affected53 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected55 at risk EG0013 affected45 at risk EG0020 affected53 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected55 at risk EG0012 affected45 at risk EG0020 affected53 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0006 affected55 at risk EG0013 affected45 at risk EG0020 affected53 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected55 at risk EG0011 affected45 at risk EG0020 affected53 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected55 at risk EG0013 affected45 at risk EG0020 affected53 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected55 at risk EG0015 affected45 at risk EG0020 affected53 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 affected55 at risk EG0012 affected45 at risk EG0020 affected53 at risk

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds