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Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

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: NCT02611830
Recruitment Status : Completed
First Posted : November 23, 2015
Results First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Colitis, Ulcerative
Interventions Drug: Vedolizumab 300 mg IV
Drug: Placebo IV
Drug: Vedolizumab 108 mg SC
Drug: Placebo SC
Enrollment 383
Recruitment Details Participants took part in the study at one hundred forty-one investigative sites in North America, South America, Western/Northern Europe, Central Europe, Eastern Europe and Africa/Asia/Australia from 18-Dec-2015 to 21-Aug-2018.
Pre-assignment Details A total of 383 participants were enrolled in open-label (OL) induction phase, 353 participants completed. 216 participants achieved clinical response at Week 6 were randomized into maintenance phase and participants who did not achieve clinical response at Week 6, received 3rd dose of open label vedolizumab IV 300 mg and completed Week 14 visit.
Arm/Group Title Open-Label Induction Phase: Vedolizumab 300 mg IV Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Hide Arm/Group Description Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Period Title: OL Induction Phase
Started 383 0 0 0
Completed [1] 353 0 0 0
Not Completed 30 0 0 0
Reason Not Completed
Pretreatment Event/Adverse Event             9             0             0             0
Significant Protocol Deviation             4             0             0             0
Voluntary Withdrawal             5             0             0             0
Lack of Efficacy             9             0             0             0
Reason not specified             3             0             0             0
[1]
Completers included randomized participants, or if not randomized, those who had Week 14 visit
Period Title: Maintenance Phase
Started [1] 0 56 106 54
Completed 0 20 75 39
Not Completed 0 36 31 15
Reason Not Completed
Lack of Efficacy             0             29             18             6
Pretreatment Event/Adverse Event             0             5             5             2
Significant Protocol Deviation             0             0             1             1
Lost to Follow-up             0             0             0             1
Voluntary Withdrawal             0             1             2             5
Pregnancy             0             0             1             0
Reason not specified             0             1             4             0
[1]
Participants who achieved clinical response at Week 6 entered the maintenance phase.
Arm/Group Title Vedolizumab IV 300 mg, Induction Phase Only Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV Total
Hide Arm/Group Description Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants who did not achieve clinical response at Week 6 were not randomized into the maintenance phase and received a 3rd dose of vedolizumab 300 mg IV infusion at Week 6. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50. Total of all reporting groups
Overall Number of Baseline Participants 167 56 106 54 383
Hide Baseline Analysis Population Description
The safety analysis set included all participants who received at least 1 dose of vedolizumab IV.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
42.7
(18 to 79)
39.4
(21 to 66)
38.1
(18 to 69)
41.6
(18 to 68)
40.79
(18 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
Female
79
  47.3%
22
  39.3%
41
  38.7%
23
  42.6%
165
  43.1%
Male
88
  52.7%
34
  60.7%
65
  61.3%
31
  57.4%
218
  56.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
Hispanic or Latino
0
   0.0%
1
   1.8%
0
   0.0%
0
   0.0%
1
   0.3%
Non-Hispanic and Latino
24
  14.4%
6
  10.7%
7
   6.6%
8
  14.8%
45
  11.7%
Not Collected
143
  85.6%
49
  87.5%
99
  93.4%
46
  85.2%
337
  88.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
American Indian or Alaska Native
2
   1.2%
1
   1.8%
0
   0.0%
0
   0.0%
3
   0.8%
Asian
39
  23.4%
13
  23.2%
14
  13.2%
5
   9.3%
71
  18.5%
Black or African American
1
   0.6%
0
   0.0%
0
   0.0%
2
   3.7%
3
   0.8%
White
125
  74.9%
42
  75.0%
92
  86.8%
47
  87.0%
306
  79.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Australia Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
1
   0.6%
0
   0.0%
2
   1.9%
1
   1.9%
4
   1.0%
Japan Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
27
  16.2%
10
  17.9%
10
   9.4%
2
   3.7%
49
  12.8%
Korea, Republic Of Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
10
   6.0%
3
   5.4%
4
   3.8%
3
   5.6%
20
   5.2%
Czech Republic Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
2
   1.2%
3
   5.4%
10
   9.4%
4
   7.4%
19
   5.0%
Hungary Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
2
   1.2%
2
   3.6%
2
   1.9%
6
  11.1%
12
   3.1%
Poland Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
37
  22.2%
13
  23.2%
35
  33.0%
10
  18.5%
95
  24.8%
Serbia Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
1
   0.6%
1
   1.8%
0
   0.0%
1
   1.9%
3
   0.8%
Slovakia Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
3
   1.8%
0
   0.0%
4
   3.8%
3
   5.6%
10
   2.6%
Bosnia Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
0
   0.0%
0
   0.0%
2
   1.9%
0
   0.0%
2
   0.5%
Bulgaria Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
3
   1.8%
1
   1.8%
1
   0.9%
1
   1.9%
6
   1.6%
Croatia Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
8
   4.8%
1
   1.8%
0
   0.0%
1
   1.9%
10
   2.6%
Estonia Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
2
   1.2%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.5%
Israel Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
2
   1.2%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.5%
Romania Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
4
   2.4%
0
   0.0%
3
   2.8%
0
   0.0%
7
   1.8%
Russia Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
12
   7.2%
0
   0.0%
5
   4.7%
3
   5.6%
20
   5.2%
Turkey Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
1
   0.6%
2
   3.6%
0
   0.0%
0
   0.0%
3
   0.8%
Ukraine Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
11
   6.6%
4
   7.1%
6
   5.7%
2
   3.7%
23
   6.0%
Canada Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
4
   2.4%
3
   5.4%
2
   1.9%
2
   3.7%
11
   2.9%
United States Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
24
  14.4%
6
  10.7%
7
   6.6%
8
  14.8%
45
  11.7%
Brazil Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
4
   2.4%
0
   0.0%
3
   2.8%
1
   1.9%
8
   2.1%
Mexico Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
2
   1.2%
1
   1.8%
0
   0.0%
0
   0.0%
3
   0.8%
Belgium Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
0
   0.0%
2
   3.6%
0
   0.0%
0
   0.0%
2
   0.5%
Denmark Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
0
   0.0%
1
   1.8%
0
   0.0%
0
   0.0%
1
   0.3%
Germany Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
0
   0.0%
3
   5.4%
3
   2.8%
1
   1.9%
7
   1.8%
Italy Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
4
   2.4%
0
   0.0%
2
   1.9%
3
   5.6%
9
   2.3%
Lithuania Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
0
   0.0%
0
   0.0%
4
   3.8%
1
   1.9%
5
   1.3%
Netherlands Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Spain Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
United Kingdom Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
1
   0.6%
0
   0.0%
1
   0.9%
1
   1.9%
3
   0.8%
Height  
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
169.3
(145 to 193)
172.4
(147 to 194)
171.9
(151 to 197)
171.2
(152 to 196)
170.7
(145 to 197)
Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
68.20
(37.0 to 150.2)
73.96
(40.6 to 160.0)
71.58
(44.0 to 131.0)
76.95
(50.6 to 124.8)
71.21
(37.0 to 160.0)
Body Mass Index (BMI)   [1] 
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
23.65
(15.1 to 40.3)
24.66
(14.1 to 51.1)
24.07
(17.0 to 41.0)
26.21
(16.3 to 35.3)
24.28
(14.1 to 51.1)
[1]
Measure Description: Body Mass Index = weight/height
Female Reproductive Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
Postmenopausal
17
  10.2%
4
   7.1%
3
   2.8%
8
  14.8%
32
   8.4%
Surgically Sterile
8
   4.8%
1
   1.8%
2
   1.9%
3
   5.6%
14
   3.7%
Female of Childbearing Potential
54
  32.3%
17
  30.4%
36
  34.0%
12
  22.2%
119
  31.1%
Participant is a male
88
  52.7%
34
  60.7%
65
  61.3%
31
  57.4%
218
  56.9%
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 56 participants 106 participants 54 participants 383 participants
Has never smoked
107
  64.1%
38
  67.9%
70
  66.0%
33
  61.1%
248
  64.8%
Is a current smoker
7
   4.2%
0
   0.0%
11
  10.4%
10
  18.5%
28
   7.3%
is an ex-smoker
53
  31.7%
18
  32.1%
25
  23.6%
11
  20.4%
107
  27.9%
Duration of Ulcerative Colitis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
7.36  (7.147) 7.96  (6.217) 8.18  (5.929) 7.86  (6.380)
[1]
Measure Analysis Population Description: Data for duration of ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Without Prior Corticosteroids or Immunomodulators Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
Yes
1
   1.8%
1
   0.9%
0
   0.0%
2
   0.9%
No
55
  98.2%
105
  99.1%
54
 100.0%
214
  99.1%
Only Prior Corticosteroids Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
Yes
22
  39.3%
28
  26.4%
21
  38.9%
71
  32.9%
No
34
  60.7%
78
  73.6%
33
  61.1%
145
  67.1%
Only Prior Immunomodulators Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
Yes
1
   1.8%
6
   5.7%
1
   1.9%
8
   3.7%
No
55
  98.2%
100
  94.3%
53
  98.1%
208
  96.3%
With Prior Corticosteroids and Immunomodulators Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
Yes
32
  57.1%
71
  67.0%
32
  59.3%
135
  62.5%
No
24
  42.9%
35
  33.0%
22
  40.7%
81
  37.5%
[1]
Measure Analysis Population Description: Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Participants with Prior TNF-alpha Antagonist Use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
Yes
20
  35.7%
40
  37.7%
24
  44.4%
84
  38.9%
No
36
  64.3%
66
  62.3%
30
  55.6%
132
  61.1%
[1]
Measure Analysis Population Description: Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.
Participants with Prior TNF-alpha Antagonist Failure   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 20 participants 40 participants 24 participants 84 participants
20
 100.0%
40
 100.0%
24
 100.0%
84
 100.0%
[1]
Measure Analysis Population Description: Data for prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.
Participants with Prior Immunomodulator Failure and Prior TNF-alpha Antagonist Failure   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 17 participants 34 participants 19 participants 70 participants
Yes
12
  70.6%
21
  61.8%
13
  68.4%
46
  65.7%
No
5
  29.4%
13
  38.2%
6
  31.6%
24
  34.3%
[1]
Measure Analysis Population Description: Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Prior TNF-alpha Antagonist Failure Number Analyzed 0 participants 20 participants 40 participants 24 participants 84 participants
Inadequate Response
9
  45.0%
21
  52.5%
13
  54.2%
43
  51.2%
Loss of Response
8
  40.0%
17
  42.5%
9
  37.5%
34
  40.5%
Intolerance
3
  15.0%
2
   5.0%
2
   8.3%
7
   8.3%
Prior Immunomodulator Failure Number Analyzed 0 participants 5 participants 22 participants 5 participants 32 participants
Inadequate Response
1
  20.0%
6
  27.3%
2
  40.0%
9
  28.1%
Loss of Response
0
   0.0%
3
  13.6%
0
   0.0%
3
   9.4%
Intolerance
4
  80.0%
13
  59.1%
3
  60.0%
20
  62.5%
Prior Corticosteroid Failure Number Analyzed 0 participants 13 participants 23 participants 15 participants 51 participants
Inadequate Response
5
  38.5%
14
  60.9%
5
  33.3%
24
  47.1%
Loss of Response
4
  30.8%
6
  26.1%
9
  60.0%
19
  37.3%
Intolerance
4
  30.8%
3
  13.0%
1
   6.7%
8
  15.7%
[1]
Measure Description: Anti-TNF failure includes all participants who failed an anti-TNF. Immunomodulator failure includes all participants who failed an immunomodulator but did not fail an anti-TNF. Corticosteroid failure includes all participants who failed a Corticosteroid and who did not fail an anti-TNF nor an Immunomodulator.
[2]
Measure Analysis Population Description: Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Baseline Disease Activity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
Moderate (Mayo Score=6 to 8)
20
  35.7%
46
  43.4%
17
  31.5%
83
  38.4%
Severe (Mayo Score=9 to 12)
36
  64.3%
60
  56.6%
37
  68.5%
133
  61.6%
[1]
Measure Analysis Population Description: Data for baseline disease activity was collected only for maintenance phase arm groups.
Baseline Fecal Calprotectin   [1] 
Mean (Standard Deviation)
Unit of measure:  Ug/g
Number Analyzed 0 participants 56 participants 102 participants 52 participants 210 participants
2393.4  (2859.66) 2607.2  (2908.67) 3173.5  (4785.48) 2690.4  (3451.64)
[1]
Measure Analysis Population Description: Data for Baseline fecal calprotectin was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for baseline fecal calprotectin.
Extraintestinal Manifestations   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
Yes
5
   8.9%
13
  12.3%
7
  13.0%
25
  11.6%
No
51
  91.1%
93
  87.7%
47
  87.0%
191
  88.4%
[1]
Measure Analysis Population Description: Data for extraintestinal manifestations was collected only for maintenance phase arm groups.
Disease Localization   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 56 participants 105 participants 54 participants 215 participants
Proctosigmoiditis
7
  12.5%
15
  14.3%
7
  13.0%
29
  13.5%
Left Sided Colitis
24
  42.9%
46
  43.8%
21
  38.9%
91
  42.3%
Extensive Colitis
4
   7.1%
7
   6.7%
7
  13.0%
18
   8.4%
Pancolitis
21
  37.5%
37
  35.2%
19
  35.2%
77
  35.8%
[1]
Measure Analysis Population Description: Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.
Corticosteroid Use at Baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 56 participants 106 participants 54 participants 216 participants
Yes
24
  42.9%
45
  42.5%
21
  38.9%
90
  41.7%
No
32
  57.1%
61
  57.5%
33
  61.1%
126
  58.3%
[1]
Measure Analysis Population Description: Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.
1.Primary Outcome
Title Percentage of Participants Achieving Clinical Remission at Week 52
Hide Description Clinical remission is defined as a complete Mayo score ≤ 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 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.
Arm/Group Title Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Hide Arm/Group Description:
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Overall Number of Participants Analyzed 56 106 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14.3
(6.4 to 26.2)
46.2
(36.5 to 56.2)
42.6
(29.2 to 56.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 32.3
Confidence Interval (2-Sided) 95%
19.7 to 45.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Mucosal Healing at Week 52
Hide Description Mucosal healing is defined as Mayo endoscopic subscore ≤1 point. The findings on endoscopy scale ranges from 0 to 3, where 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).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.
Arm/Group Title Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Hide Arm/Group Description:
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Overall Number of Participants Analyzed 56 106 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.4
(11.6 to 34.4)
56.6
(46.6 to 66.2)
53.7
(39.6 to 67.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 35.7
Confidence Interval (2-Sided) 95%
22.1 to 49.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52
Hide Description Durable clinical response is defined as clinical response at both Weeks 6 and 52, where clinical response is defined as a 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. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Time Frame Baseline, Weeks 6 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.
Arm/Group Title Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Hide Arm/Group Description:
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Overall Number of Participants Analyzed 56 106 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.6
(17.3 to 42.2)
64.2
(54.3 to 73.2)
72.2
(58.4 to 83.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 36.1
Confidence Interval (2-Sided) 95%
21.2 to 50.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52
Hide Description Durable clinical remission is defined as clinical remission at both Weeks 6 and 52. Clinical remission is defined as a complete Mayo score of less than or equal to (≤) 2 points and no individual subscore greater than (>) 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Time Frame Weeks 6 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.
Arm/Group Title Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Hide Arm/Group Description:
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Overall Number of Participants Analyzed 56 106 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.4
(1.1 to 14.9)
15.1
(8.9 to 23.4)
16.7
(7.9 to 29.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments P-value was calculated by Fisher's Exact Test.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
-6.6 to 25.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Hide Description Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. 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 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from FAS, who used concomitant oral corticosteroid at Baseline. FAS included all randomized participants who received at least 1 dose of study drug and who only received induction IV therapy and were not randomized into maintenance phase were not included in FAS; participants were analyzed according to randomized treatment assignment.
Arm/Group Title Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Hide Arm/Group Description:
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Overall Number of Participants Analyzed 24 45 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(1.0 to 27.0)
28.9
(16.4 to 44.3)
28.6
(11.3 to 52.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments P-value was calculated by Fisher's Exact Test.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.6
Confidence Interval (2-Sided) 95%
-4.5 to 43.7
Estimation Comments [Not Specified]
Time Frame From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks)
Adverse Event Reporting Description At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Vedolizumab IV 300 mg, Induction Phase Only Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Hide Arm/Group Description Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants who did not achieve clinical response at Week 6 were not randomized into the maintenance phase and received a 3rd dose of vedolizumab 300 mg IV infusion at Week 6. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50. Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
All-Cause Mortality
Vedolizumab IV 300 mg, Induction Phase Only Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/167 (0.00%)   0/56 (0.00%)   0/106 (0.00%)   0/54 (0.00%) 
Hide Serious Adverse Events
Vedolizumab IV 300 mg, Induction Phase Only Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/167 (10.18%)   6/56 (10.71%)   10/106 (9.43%)   7/54 (12.96%) 
Blood and lymphatic system disorders         
Anaemia  1  2/167 (1.20%)  1/56 (1.79%)  2/106 (1.89%)  0/54 (0.00%) 
Cardiac disorders         
Tachycardia  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Gastrointestinal disorders         
Colitis ulcerative  1  12/167 (7.19%)  5/56 (8.93%)  3/106 (2.83%)  1/54 (1.85%) 
Acute abdomen  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Large intestine perforation  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Abdominal pain lower  1  1/167 (0.60%)  0/56 (0.00%)  0/106 (0.00%)  0/54 (0.00%) 
Colitis  1  1/167 (0.60%)  0/56 (0.00%)  0/106 (0.00%)  0/54 (0.00%) 
General disorders         
Drug resistance  1  1/167 (0.60%)  0/56 (0.00%)  0/106 (0.00%)  0/54 (0.00%) 
Pyrexia  1  1/167 (0.60%)  0/56 (0.00%)  0/106 (0.00%)  0/54 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Infections and infestations         
Anal abscess  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Peritonitis  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Tonsillitis  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Clostridium difficile infection  1  1/167 (0.60%)  0/56 (0.00%)  0/106 (0.00%)  0/54 (0.00%) 
Injury, poisoning and procedural complications         
Craniocerebral injury  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Clavicle fracture  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Scapula fracture  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Ligament rupture  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Road traffic accident  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Facial bones fracture  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Jaw fracture  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Lumbar vertebral fracture  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Rib fracture  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Post procedural haemorrhage  1  1/167 (0.60%)  0/56 (0.00%)  0/106 (0.00%)  0/54 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  1  0/167 (0.00%)  1/56 (1.79%)  0/106 (0.00%)  0/54 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Rectal adenocarcinoma  1  1/167 (0.60%)  0/56 (0.00%)  0/106 (0.00%)  0/54 (0.00%) 
Psychiatric disorders         
Major depression  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary sarcoidosis  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Pneumothorax  1  0/167 (0.00%)  0/56 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
1
Term from vocabulary, MedDRA version 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vedolizumab IV 300 mg, Induction Phase Only Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/167 (20.36%)   31/56 (55.36%)   42/106 (39.62%)   31/54 (57.41%) 
Blood and lymphatic system disorders         
Anaemia  1  9/167 (5.39%)  2/56 (3.57%)  5/106 (4.72%)  5/54 (9.26%) 
Gastrointestinal disorders         
Colitis ulcerative  1  7/167 (4.19%)  14/56 (25.00%)  12/106 (11.32%)  5/54 (9.26%) 
Infections and infestations         
Nasopharyngitis  1  4/167 (2.40%)  11/56 (19.64%)  11/106 (10.38%)  10/54 (18.52%) 
Upper respiratory tract infection  1  3/167 (1.80%)  1/56 (1.79%)  10/106 (9.43%)  2/54 (3.70%) 
Sinusitis  1  0/167 (0.00%)  3/56 (5.36%)  1/106 (0.94%)  0/54 (0.00%) 
Urinary tract infection  1  5/167 (2.99%)  2/56 (3.57%)  0/106 (0.00%)  4/54 (7.41%) 
Investigations         
Alanine aminotransferase increased  1  1/167 (0.60%)  0/56 (0.00%)  1/106 (0.94%)  3/54 (5.56%) 
Blood creatine phosphokinase increased  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  3/54 (5.56%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  4/167 (2.40%)  1/56 (1.79%)  6/106 (5.66%)  4/54 (7.41%) 
Nervous system disorders         
Headache  1  5/167 (2.99%)  6/56 (10.71%)  9/106 (8.49%)  0/54 (0.00%) 
Psychiatric disorders         
Insomnia  1  0/167 (0.00%)  0/56 (0.00%)  1/106 (0.94%)  3/54 (5.56%) 
Skin and subcutaneous tissue disorders         
Rash  1  0/167 (0.00%)  1/56 (1.79%)  1/106 (0.94%)  3/54 (5.56%) 
1
Term from vocabulary, MedDRA version 21.0
Indicates events were collected by systematic assessment
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: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02611830    
Other Study ID Numbers: MLN0002SC-3027
2015-000480-14 ( EudraCT Number )
U1111-1168-0813 ( Registry Identifier: WHO )
16/LO/0089 ( Registry Identifier: NRES )
NL55501.056.15 ( Registry Identifier: CCMO )
JapicCTI-163222 ( Registry Identifier: JapicCTI )
189732 ( Registry Identifier: HC-CTD )
163300410A0046 ( Registry Identifier: NREC )
First Submitted: November 19, 2015
First Posted: November 23, 2015
Results First Submitted: May 29, 2019
Results First Posted: January 23, 2020
Last Update Posted: January 23, 2020