Trial Outcomes & Findings for Triple Combination Therapy in High Risk Crohn's Disease (CD) (NCT NCT02764762)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

55 participants

Primary outcome timeframe

Week 26

Results posted on

2023-07-14

Participant Flow

Participants took part in the study at 23 investigative sites in Canada and United States from 18 April 2017 to 05 July 2022.

Participants with newly-diagnosed Crohn's Disease (CD) with higher risk for complications were enrolled into triple combination therapy to assess efficacy and safety of vedolizumab 300 mg, adalimumab 160/80/40 mg, and methotrexate 15 mg, following monotherapy of vedolizumab 300 mg.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	55
Overall Study Triple Combination Therapy	55
Overall Study Monotherapy	45
Overall Study Safety Follow-up	53
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Pretreatment Event/Adverse Event	9
Overall Study Lost to Follow-up	4
Overall Study Voluntary Withdrawal	8
Overall Study Site Termination	1
Overall Study Lack of Efficacy	16
Overall Study Reason not Specified	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15mg (Oral) n=55 Participants 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. 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.
Age, Continuous	32.4 years STANDARD_DEVIATION 12.38 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Height	171.4 cm STANDARD_DEVIATION 9.55 • n=5 Participants
Weight	71.87 kg STANDARD_DEVIATION 18.373 • n=5 Participants
Body Mass Index (BMI)	24.26 kg/m^2 STANDARD_DEVIATION 5.029 • n=5 Participants
Region of Enrollment Canada	14 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 26

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Percentage of Participants Achieving Endoscopic Remission at Week 26	34.5 percentage of participants Interval 21.1 to 48.0	—

SECONDARY outcome

Timeframe: Week 26

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

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Percentage of Participants Achieving Endoscopic Healing at Week 26	43.6 percentage of participants Interval 29.6 to 57.7	—

SECONDARY outcome

Timeframe: Week 26

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

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Percentage of Participants Achieving Endoscopic Response at Week 26	56.4 percentage of participants Interval 42.3 to 70.4	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Change From Baseline in SES-CD Score at Week 26 Baseline	12.6 score on a scale Standard Deviation 5.67	—
Change From Baseline in SES-CD Score at Week 26 Change From Baseline at Week 26	-8.9 score on a scale Standard Deviation 7.29	—

SECONDARY outcome

Timeframe: Week 26

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

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Percentage of Participants Achieving Deep Remission at Week 26	21.8 percentage of participants Interval 10.0 to 33.6	—

SECONDARY outcome

Timeframe: Week 26

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

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Percentage of Participants Achieving Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 26	38.2 percentage of participants Interval 24.4 to 51.9	—

SECONDARY outcome

Timeframe: Weeks 10 and 26

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

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Percentage of Participants Achieving Clinical Remission at Weeks 10 and 26 Week 10	60.0 percentage of participants Interval 46.1 to 73.9	—
Percentage of Participants Achieving Clinical Remission at Weeks 10 and 26 Week 26	54.5 percentage of participants Interval 40.5 to 68.6	—

SECONDARY outcome

Timeframe: Weeks 10 and 26

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

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Percentage of Participants Achieving Clinical Response at Weeks 10 and 26 Week 10	49.1 percentage of participants Interval 35.0 to 63.2	—
Percentage of Participants Achieving Clinical Response at Weeks 10 and 26 Week 26	43.6 percentage of participants Interval 29.6 to 57.7	—

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 26

Population: 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.

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

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	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.
Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26 Baseline	7.60 milligrams per liter (mg/L) Interval 0.6 to 135.8	—
Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26 Change From Baseline at Week 10	-4.80 milligrams per liter (mg/L) Interval -84.0 to 29.7	—
Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26 Change From Baseline at Week 26	-5.50 milligrams per liter (mg/L) Interval -79.3 to 104.3	—

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 Participants 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.	Vedolizumab 300 mg (IV) n=45 Participants 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.
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 Baseline	1301.0 micrograms per gram Interval 23.0 to 17707.0	1210.0 micrograms per gram Interval 23.0 to 17707.0
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 Change From Baseline at Week 10	-864.0 micrograms per gram Interval -16406.0 to 471.0	—
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 Change From Baseline at Week 14	-556.0 micrograms per gram Interval -14742.0 to 6892.0	—
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 Change From Baseline at Week 26	-860.5 micrograms per gram Interval -7911.0 to 440.0	—
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 Change From Baseline at Week 52	—	-350.0 micrograms per gram Interval -7365.0 to 8021.0
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 Change From Baseline at Week 78	—	-396.5 micrograms per gram Interval -7844.0 to 9434.0
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 Change From Baseline at Week 102	—	-452.0 micrograms per gram Interval -8052.0 to 106.0

SECONDARY outcome

Timeframe: Weeks 26, 52, 78 and 102

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=39 Participants 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.	Vedolizumab 300 mg (IV) n=34 Participants 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.
Percentage of Participants Achieving Clinical Remission and CRP <5 Milligram Per Liter (mg/L) at Weeks 26, 52, 78, and 102 Week 26	51.3 percentage of participants Interval 34.3 to 68.3	—
Percentage of Participants Achieving Clinical Remission and CRP <5 Milligram Per Liter (mg/L) at Weeks 26, 52, 78, and 102 Week 52	—	44.1 percentage of participants Interval 26.0 to 62.3
Percentage of Participants Achieving Clinical Remission and CRP <5 Milligram Per Liter (mg/L) at Weeks 26, 52, 78, and 102 Week 78	—	26.5 percentage of participants Interval 10.2 to 42.8
Percentage of Participants Achieving Clinical Remission and CRP <5 Milligram Per Liter (mg/L) at Weeks 26, 52, 78, and 102 Week 102	—	20.6 percentage of participants Interval 5.5 to 35.7

SECONDARY outcome

Timeframe: Weeks 10, 26 and 102

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=16 Participants 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.	Vedolizumab 300 mg (IV) n=14 Participants 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.
Percentage of Participants Using Oral Corticosteroids at Baseline Who Have Discontinued Corticosteroids and Are in Clinical Remission at Weeks 10, 26, and 102 Week 10	50.0 percentage of participants Interval 22.4 to 77.6	—
Percentage of Participants Using Oral Corticosteroids at Baseline Who Have Discontinued Corticosteroids and Are in Clinical Remission at Weeks 10, 26, and 102 Week 26	56.3 percentage of participants Interval 28.8 to 83.7	—
Percentage of Participants Using Oral Corticosteroids at Baseline Who Have Discontinued Corticosteroids and Are in Clinical Remission at Weeks 10, 26, and 102 Week 102	—	21.4 percentage of participants Interval 0.0 to 46.5

SECONDARY outcome

Timeframe: Weeks 52, 78 and 102

Population: 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 at Week 26.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=30 Participants 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.	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.
Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102 Week 52	50.0 percentage of participants Interval 30.4 to 69.6	—
Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102 Week 78	33.3 percentage of participants Interval 14.8 to 51.9	—
Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102 Week 102	20.0 percentage of participants Interval 4.0 to 36.0	—

SECONDARY outcome

Timeframe: Weeks 52, 78 and 102

Population: 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 response at Week 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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=24 Participants 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.	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.
Percentage of Participants Maintaining Clinical Response at Weeks 52, 78, and 102 Week 52	66.7 percentage of participants Interval 45.7 to 87.6	—
Percentage of Participants Maintaining Clinical Response at Weeks 52, 78, and 102 Week 78	45.8 percentage of participants Interval 23.8 to 67.9	—
Percentage of Participants Maintaining Clinical Response at Weeks 52, 78, and 102 Week 102	29.2 percentage of participants Interval 8.9 to 49.4	—

SECONDARY outcome

Timeframe: Week 102

Population: 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 endoscopic remission at Week 26.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=18 Participants 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.	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.
Percentage of Participants Maintaining Endoscopic Remission at Week 102	27.8 percentage of participants Interval 4.3 to 51.2	—

SECONDARY outcome

Timeframe: Week 102

Population: 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 deep remission at Week 26.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=12 Participants 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.	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.
Percentage of Participants Maintaining Deep Remission at Week 102	8.3 percentage of participants Interval 0.0 to 28.1	—

SECONDARY outcome

Timeframe: Week 102

Population: 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 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, 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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=23 Participants 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.	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.
Percentage of Participants Maintaining Endoscopic Healing at Week 102	34.8 percentage of participants Interval 13.1 to 56.4	—

SECONDARY outcome

Timeframe: Week 102

Population: 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 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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=30 Participants 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.	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.
Percentage of Participants Maintaining Endoscopic Response at Week 102	50.0 percentage of participants Interval 30.4 to 69.6	—

SECONDARY outcome

Timeframe: Week 102

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=21 Participants 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.	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.
Percentage of Participants Maintaining Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 102	19.0 percentage of participants Interval 0.0 to 38.2	—

SECONDARY outcome

Timeframe: After 26 Weeks up to Week 120

Population: 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 data available for analysis.

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.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=45 Participants 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.	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.
Percentage of Participants With First Exacerbation of CD	62.2 percentage of participants Interval 46.9 to 77.5	—

Adverse Events

Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)

Serious events: 6 serious events

Other events: 36 other events

Deaths: 0 deaths

Vedolizumab 300 mg (IV)

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Safety Follow-up

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral) n=55 participants at risk 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.	Vedolizumab 300 mg (IV) n=45 participants at risk 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.	Safety Follow-up n=53 participants at risk 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.
Infections and infestations Abdominal wall abscess	0.00% 0/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	1.9% 1/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.
Infections and infestations Appendicitis	0.00% 0/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	2.2% 1/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.
Gastrointestinal disorders Colonic fistula	0.00% 0/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	1.9% 1/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.
Gastrointestinal disorders Crohn's disease	1.8% 1/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.
Infections and infestations Gastroenteritis	1.8% 1/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.
Blood and lymphatic system disorders Lymphadenopathy	1.8% 1/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.
Infections and infestations Perirectal abscess	1.8% 1/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.
General disorders Pyrexia	1.8% 1/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.
Gastrointestinal disorders Small intestinal obstruction	3.6% 2/55 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	0.00% 0/45 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.	1.9% 1/53 • From the first dose up to EOS (up to 120 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for the safety was collected and reported separately for triple combination therapy, monotherapy, and the safety follow up.

Other adverse events

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