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Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis (GEMINI I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00783718
Recruitment Status : Completed
First Posted : November 2, 2008
Results First Posted : July 18, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: vedolizumab
Other: Placebo
Enrollment 895
Recruitment Details Participants took part in the study at 211 investigative sites worldwide. The Induction Phase contained 2 cohorts. The eligibility criteria for both cohorts were identical. The purpose of Cohort 2 was to provide enough responders to power the Maintenance Phase primary efficacy analysis.
Pre-assignment Details In Cohort 1, eligible patients who met entry criteria were randomized to treatment with double-blind vedolizumab 300 mg or placebo in a 3:2 ratio. All Cohort 2 patients were treated with open-label vedolizumab. In the Maintenance Phase participants were assigned to treatment groups based on their Induction Phase treatment and response to therapy.
Arm/Group Title Placebo Induction Phase: DB Vedolizumab Induction Phase: OL Vedolizumab Maintenance Phase: Placebo Maintenance Phase: Vedolizumab Q8W Maintenance Phase: Vedolizumab Q4W Maintenance Phase: Non-responders
Hide Arm/Group Description In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction. In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2. In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2. Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase. Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50. Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50. Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
Period Title: Induction Phase
Started 149 225 521 0 0 0 0
Completed 135 218 485 0 0 0 0
Not Completed 14 7 36 0 0 0 0
Reason Not Completed
Adverse Event             4             0             7             0             0             0             0
Protocol Violation             1             1             6             0             0             0             0
Lack of Efficacy             5             2             14             0             0             0             0
Withdrawal by Subject             3             4             8             0             0             0             0
Lost to Follow-up             1             0             1             0             0             0             0
Period Title: Maintenance Phase
Started 135 0 0 126 122 125 330
Completed 30 0 0 48 77 84 135
Not Completed 105 0 0 78 45 41 195
Reason Not Completed
Adverse Event             12             0             0             15             7             6             16
Protocol Violation             1             0             0             0             0             0             2
Lack of Efficacy             83             0             0             61             31             33             155
Withdrawal by Subject             6             0             0             2             5             2             20
Lost to Follow-up             3             0             0             0             2             0             2
Arm/Group Title Placebo Induction Phase: DB Vedolizumab Induction Phase: OL Vedolizumab Total
Hide Arm/Group Description In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction. In the Induction Phase participants in Cohort 1 were randomized to receive double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2. In the Induction Phase participants in Cohort 2 received open-label vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2. Total of all reporting groups
Overall Number of Baseline Participants 149 225 521 895
Hide Baseline Analysis Population Description
Baseline characteristics are provided for the Induction Phase Safety Population, defined as all participants, in both Cohort 1 and Cohort 2, who received any amount of study drug in the Induction Phase (Weeks 0-6), according to the actual study drug received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants 225 participants 521 participants 895 participants
41.2  (12.50) 40.1  (13.11) 40.1  (13.27) 40.3  (13.09)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
< 35 53 86 214 353
≥ 35 96 139 307 542
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
< 65 142 217 503 862
≥ 65 7 8 18 33
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
Female
57
  38.3%
93
  41.3%
220
  42.2%
370
  41.3%
Male
92
  61.7%
132
  58.7%
301
  57.8%
525
  58.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
White 115 183 436 734
Black 2 5 5 12
Asian 32 36 67 135
Other 0 1 13 14
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
Hispanic or Latino 5 10 31 46
Not Hispanic or Latino 140 211 481 832
Not reported 4 4 9 17
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
Australia 7 17 29 53
Austria 4 3 12 19
Belgium 7 14 35 56
Bulgaria 2 1 3 6
Canada 16 14 62 92
Czech Republic 7 12 19 38
Denmark 2 7 5 14
Estonia 1 4 5 10
France 1 3 13 17
Germany 0 1 16 17
Greece 0 1 4 5
Hong Kong 0 0 1 1
Hungary 2 6 8 16
Iceland 0 1 2 3
India 18 16 24 58
Ireland 0 0 1 1
Israel 0 1 1 2
Italy 1 9 11 21
Korea, Republic of 5 10 26 41
Latvia 1 2 0 3
Malaysia 5 2 2 9
Netherlands 1 0 2 3
New Zealand 0 5 6 11
Norway 2 1 6 9
Poland 2 6 52 60
Russian Federation 9 15 25 49
Singapore 0 0 1 1
South Africa 4 5 10 19
Spain 0 0 2 2
Switzerland 2 1 3 6
Turkey 0 3 3 6
United Kingdom 2 0 4 6
United States 47 64 127 238
Body Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 149 participants 225 participants 521 participants 895 participants
72.4  (17.65) 72.4  (17.11) 74.2  (19.32) 73.4  (18.51)
[1]
Measure Description: Body weight data only available for 148 participants in the placebo arm.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 149 participants 225 participants 521 participants 895 participants
24.6  (5.11) 24.9  (4.85) 25.3  (6.05) 25.1  (5.62)
[1]
Measure Description: BMI data only available for 148 participants in the placebo arm.
Duration of Ulcerative Colitis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants 225 participants 521 participants 895 participants
7.1  (7.25) 6.1  (5.08) 7.2  (6.61) 6.9  (6.39)
[1]
Measure Description: Duration of ulcerative colitis data only available for 519 participants in the Induction Phase: OL Vedolizumab arm.
Categorical Duration of Ulcerative Colitis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
< 1 year 13 13 38 64
≥1 - < 3 years 44 63 121 228
≥ 3 - < 7 years 39 77 163 279
≥ 7 years 53 72 197 322
Missing 0 0 2 2
Baseline Mayo Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 149 participants 225 participants 521 participants 895 participants
8.6  (1.68) 8.5  (1.78) 8.6  (1.76) 8.6  (1.75)
[1]
Measure Description: The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).
Baseline Disease Activity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
Complete Mayo score < 6 5 6 14 25
Complete Mayo score of 6 to 8 (inclusive) 70 105 249 424
Complete Mayo score of 9 to 12 (inclusive) 74 114 258 446
Baseline Fecal Calprotectin   [1] 
Mean (Standard Deviation)
Unit of measure:  μg/g
Number Analyzed 149 participants 225 participants 521 participants 895 participants
2369.9  (3258.82) 2552.2  (3800.36) 1442.7  (1855.61) 1868.8  (2753.28)
[1]
Measure Description: Number of participants for whom baseline fecal calprotectin data were available were 139, 213, and 505, respectively.
Categorical Baseline Fecal Calprotectin  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
≤ 250 μg/g 27 37 94 158
> 250 to ≤ 500 μg/g 20 20 82 122
> 500 μg/g 92 156 329 577
Missing 10 12 16 38
Disease Localization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
Proctosigmoiditis 22 25 69 116
Left-sided colitis 59 92 188 339
Extensive colitis 18 25 66 109
Pancolitis 50 83 198 331
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
Current smoker 11 12 32 55
Nonsmoker 88 145 322 555
Former smoker 50 68 167 285
History of Extraintestinal Manifestations  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 225 participants 521 participants 895 participants
Yes 44 74 180 298
No 105 151 341 597
1.Primary Outcome
Title Induction Phase: Percentage of Participants With a Clinical Response at Week 6
Hide Description

Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.

The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

All participants who prematurely discontinued for any reason were considered as not achieving clinical response.

Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Induction Study Intent-to-treat (ITT) population which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.
Arm/Group Title Placebo DB Vedolizumab
Hide Arm/Group Description:
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
Overall Number of Participants Analyzed 149 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.5
(18.5 to 32.5)
47.1
(40.6 to 53.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DB Vedolizumab
Comments The primary comparison of the Induction Phase was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level, with stratification according to the stratification factors (concomitant use of oral corticosteroids and previous exposure to tumor necrosis factor alpha (TNFα) antagonists or concomitant immunomodulator [6-mercaptopurine or azathioprine] use).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 21.7
Confidence Interval (2-Sided) 95%
11.6 to 31.7
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52
Hide Description

Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.

The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.
Arm/Group Title Placebo Vedolizumab Q8W Vedolizumab Q4W
Hide Arm/Group Description:
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
Overall Number of Participants Analyzed 126 122 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.9
(9.5 to 22.3)
41.8
(33.1 to 50.6)
44.8
(36.1 to 53.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q8W
Comments The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was > 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 26.1
Confidence Interval (2-Sided) 95%
14.9 to 37.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q4W
Comments The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was > 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.1
Confidence Interval (2-Sided) 95%
17.9 to 40.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Induction Phase: Percentage of Participants in Clinical Remission at Week 6
Hide Description

Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.

The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Induction Study ITT Population
Arm/Group Title Placebo DB Vedolizumab
Hide Arm/Group Description:
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
Overall Number of Participants Analyzed 149 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.4
(1.7 to 9.0)
16.9
(12.0 to 21.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DB Vedolizumab
Comments To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.5
Confidence Interval (2-Sided) 95%
4.7 to 18.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Induction Phase: Percentage of Participants With Mucosal Healing at Week 6
Hide Description

Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.

The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:

0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing.

Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Induction Study ITT Population
Arm/Group Title Placebo DB Vedolizumab
Hide Arm/Group Description:
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
Overall Number of Participants Analyzed 149 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.8
(17.9 to 31.8)
40.9
(34.5 to 47.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DB Vedolizumab
Comments To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.1
Confidence Interval 95%
6.4 to 25.9
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Maintenance Phase: Percentage of Participants With Durable Clinical Response
Hide Description

Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response.

Time Frame Baseline, Week 6 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Study ITT Population
Arm/Group Title Placebo Vedolizumab Q8W Vedolizumab Q4W
Hide Arm/Group Description:
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
Overall Number of Participants Analyzed 126 122 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.8
(16.4 to 31.2)
56.6
(47.8 to 65.4)
52.0
(43.2 to 60.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q8W
Comments To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 32.8
Confidence Interval (2-Sided) 95%
20.8 to 44.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q4W
Comments To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 28.5
Confidence Interval (2-Sided) 95%
16.7 to 40.3
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52
Hide Description

Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.

The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:

0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Study ITT Population
Arm/Group Title Placebo Vedolizumab Q8W Vedolizumab Q4W
Hide Arm/Group Description:
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
Overall Number of Participants Analyzed 126 122 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.8
(12.9 to 26.8)
51.6
(42.8 to 60.5)
56.0
(47.3 to 64.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q8W
Comments To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 32.0
Confidence Interval (2-Sided) 95%
20.3 to 43.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q4W
Comments To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 36.3
Confidence Interval (2-Sided) 95%
24.4 to 48.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Hide Description

Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission.

Time Frame Week 6 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Study ITT Population
Arm/Group Title Placebo Vedolizumab Q8W Vedolizumab Q4W
Hide Arm/Group Description:
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
Overall Number of Participants Analyzed 126 122 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.7
(3.8 to 13.7)
20.5
(13.3 to 27.7)
24.0
(16.5 to 31.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q8W
Comments To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0079
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
3.1 to 20.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q4W
Comments To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 15.3
Confidence Interval (2-Sided) 95%
6.2 to 24.4
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52
Hide Description

Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.

The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.
Arm/Group Title Placebo Vedolizumab Q8W Vedolizumab Q4W
Hide Arm/Group Description:
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
Overall Number of Participants Analyzed 72 70 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.9
(5.9 to 21.9)
31.4
(20.6 to 42.3)
45.2
(33.8 to 56.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q8W
Comments To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0120
Comments P-value based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.6
Confidence Interval (2-Sided) 95%
3.9 to 31.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab Q4W
Comments To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 31.4
Confidence Interval (2-Sided) 95%
16.6 to 46.2
Estimation Comments [Not Specified]
Time Frame From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vedolizumab Then Placebo Vedolizumab
Hide Arm/Group Description Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase. Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase. Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
All-Cause Mortality
Placebo Vedolizumab Then Placebo Vedolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Vedolizumab Then Placebo Vedolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/149 (11.41%)   20/126 (15.87%)   77/620 (12.42%) 
Blood and lymphatic system disorders       
Anaemia  1  1/149 (0.67%)  1/126 (0.79%)  1/620 (0.16%) 
Cardiac disorders       
Arteriosclerosis coronary artery  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Atrial fibrillation  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Aortic valve stenosis  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Ear and labyrinth disorders       
Vertigo positional  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Gastrointestinal disorders       
Colitis ulcerative  1  10/149 (6.71%)  7/126 (5.56%)  47/620 (7.58%) 
Abdominal pain  1  1/149 (0.67%)  0/126 (0.00%)  2/620 (0.32%) 
Small intestinal obstruction  1  1/149 (0.67%)  0/126 (0.00%)  1/620 (0.16%) 
Abdominal pain upper  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Ileus  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Nausea  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Peritoneal haemorrhage  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Subileus  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Upper gastrointestinal haemorrhage  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Colon dysplasia  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Pancreatitis acute  1  1/149 (0.67%)  0/126 (0.00%)  0/620 (0.00%) 
Rectal haemorrhage  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
General disorders       
Fatigue  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Multi-organ failure  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Pyrexia  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Cholangitis sclerosing  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Hepatitis acute  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Immune system disorders       
Sarcoidosis  1  1/149 (0.67%)  0/126 (0.00%)  0/620 (0.00%) 
Infections and infestations       
Anal abscess  1  0/149 (0.00%)  0/126 (0.00%)  2/620 (0.32%) 
Wound infection  1  0/149 (0.00%)  0/126 (0.00%)  2/620 (0.32%) 
Perirectal abscess  1  1/149 (0.67%)  0/126 (0.00%)  1/620 (0.16%) 
Sepsis  1  1/149 (0.67%)  0/126 (0.00%)  1/620 (0.16%) 
Urinary tract infection  1  1/149 (0.67%)  0/126 (0.00%)  1/620 (0.16%) 
Bronchitis  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Cellulitis  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Cholangitis suppurative  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Klebsiella infection  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Lower respiratory tract infection  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Pulpitis dental  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Tonsillitis  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Appendicitis  1  0/149 (0.00%)  2/126 (1.59%)  0/620 (0.00%) 
Infection  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Pelvic abscess  1  1/149 (0.67%)  0/126 (0.00%)  0/620 (0.00%) 
Pericoronitis  1  1/149 (0.67%)  0/126 (0.00%)  0/620 (0.00%) 
Pneumonia  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Injury, poisoning and procedural complications       
Accidental poisoning  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Fall  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Fibula fracture  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Gastrointestinal stoma complication  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Wrist fracture  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Concussion  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Pubis fracture  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Investigations       
Haemoglobin decrease  1  0/149 (0.00%)  1/126 (0.79%)  1/620 (0.16%) 
Lipase increased  1  1/149 (0.67%)  0/126 (0.00%)  0/620 (0.00%) 
Weight decreased  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  1/149 (0.67%)  0/126 (0.00%)  2/620 (0.32%) 
Musculoskeletal and connective tissue disorders       
Osteoporosis  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/149 (0.00%)  1/126 (0.79%)  1/620 (0.16%) 
Transitional cell carcinoma  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Nervous system disorders       
Syncope  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Renal and urinary disorders       
Renal failure  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Tubulointerstitial nephritis  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Reproductive system and breast disorders       
Menorrhagia  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Benign prostatic hyperplasia  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  1/149 (0.67%)  0/126 (0.00%)  2/620 (0.32%) 
Pneumothorax  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Pleural effusion  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Skin and subcutaneous tissue disorders       
Pemphigoid  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Rash  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Vascular disorders       
Deep vein thrombosis  1  0/149 (0.00%)  0/126 (0.00%)  1/620 (0.16%) 
Arteriosclerosis obliterans  1  1/149 (0.67%)  0/126 (0.00%)  0/620 (0.00%) 
Venous thrombosis  1  0/149 (0.00%)  1/126 (0.79%)  0/620 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Vedolizumab Then Placebo Vedolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   67/149 (44.97%)   69/126 (54.76%)   321/620 (51.77%) 
Blood and lymphatic system disorders       
Anaemia  1  10/149 (6.71%)  4/126 (3.17%)  35/620 (5.65%) 
Gastrointestinal disorders       
Colitis ulcerative  1  20/149 (13.42%)  22/126 (17.46%)  57/620 (9.19%) 
Nausea  1  11/149 (7.38%)  8/126 (6.35%)  38/620 (6.13%) 
Abdominal pain  1  7/149 (4.70%)  2/126 (1.59%)  34/620 (5.48%) 
General disorders       
Fatigue  1  5/149 (3.36%)  5/126 (3.97%)  32/620 (5.16%) 
Infections and infestations       
Nasopharyngitis  1  11/149 (7.38%)  15/126 (11.90%)  80/620 (12.90%) 
Upper respiratory tract infection  1  8/149 (5.37%)  13/126 (10.32%)  52/620 (8.39%) 
Bronchitis  1  5/149 (3.36%)  7/126 (5.56%)  23/620 (3.71%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  10/149 (6.71%)  15/126 (11.90%)  56/620 (9.03%) 
Nervous system disorders       
Headache  1  13/149 (8.72%)  15/126 (11.90%)  80/620 (12.90%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  7/149 (4.70%)  6/126 (4.76%)  36/620 (5.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Millennium Pharmaceuticals Inc
Phone: 800-778-2860
EMail: clinicaltrialregistry@tpna.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00783718    
Other Study ID Numbers: C13006
U1111-1156-8422 ( Registry Identifier: WHO )
2008-002782-32 ( EudraCT Number )
NL25207.096.08 ( Registry Identifier: CCMO )
CTRI/2009/091/000128 ( Registry Identifier: CTRI )
NMRR-08-1046-2201 ( Registry Identifier: NMRR )
C13006CTIL ( Other Identifier: Israel MoH )
09/H1102/66 ( Registry Identifier: NRES )
First Submitted: October 31, 2008
First Posted: November 2, 2008
Results First Submitted: June 19, 2014
Results First Posted: July 18, 2014
Last Update Posted: July 18, 2014