Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With 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: NCT02497469
Recruitment Status : Completed
First Posted : July 14, 2015
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Colitis, Ulcerative
Interventions Drug: Vedolizumab
Drug: Adalimumab placebo
Drug: Adalimumab
Drug: Vedolizumab placebo
Enrollment 771
Recruitment Details Participants took part in the study at 205 investigative sites worldwide from 29 June 2015 up to 18 January 2019.
Pre-assignment Details Participants with a diagnosis of moderately to severely active ulcerative colitis (UC) were enrolled in a 1:1 ratio to receive vedolizumab or adalimumab and matching placebo.
Arm/Group Title Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg
Hide Arm/Group Description Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
Period Title: Overall Study
Started 386 385
Safety Analysis Set [1] 386 383
Completed 217 270
Not Completed 169 115
Reason Not Completed
Randomized but not Treated             0             2
Pretreatment Event/Adverse Event             18             16
Leukopenia or Lymphopenia             1             0
Significant Protocol Deviation             4             5
Lost to Follow-up             14             4
Voluntary Withdrawal             39             41
Pregnancy             1             1
Lack of Efficacy             86             40
Reason not Specified             6             6
[1]
Participants who received at least one dose of study drug.
Arm/Group Title Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg Total
Hide Arm/Group Description Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50. Total of all reporting groups
Overall Number of Baseline Participants 386 385 771
Hide Baseline Analysis Population Description
Randomized Set included all participants who were randomized into the study, regardless of whether they received any dose of the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 386 participants 385 participants 771 participants
40.5  (13.44) 40.8  (13.74) 40.7  (13.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 385 participants 771 participants
Female
170
  44.0%
151
  39.2%
321
  41.6%
Male
216
  56.0%
234
  60.8%
450
  58.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 385 participants 771 participants
Hispanic or Latino
6
   1.6%
8
   2.1%
14
   1.8%
Not Hispanic or Latino
39
  10.1%
23
   6.0%
62
   8.0%
Unknown or Not Reported
341
  88.3%
354
  91.9%
695
  90.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 385 participants 771 participants
American Indian or Alaska Native
11
   2.8%
4
   1.0%
15
   1.9%
Asian
30
   7.8%
32
   8.3%
62
   8.0%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.1%
Black or African American
3
   0.8%
2
   0.5%
5
   0.6%
White
341
  88.3%
345
  89.6%
686
  89.0%
More than one race
0
   0.0%
2
   0.5%
2
   0.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Australia Number Analyzed 386 participants 385 participants 771 participants
3
   0.8%
5
   1.3%
8
   1.0%
Hong Kong Number Analyzed 386 participants 385 participants 771 participants
1
   0.3%
4
   1.0%
5
   0.6%
Korea, Republic Of Number Analyzed 386 participants 385 participants 771 participants
19
   4.9%
16
   4.2%
35
   4.5%
Taiwan, Province Of China Number Analyzed 386 participants 385 participants 771 participants
4
   1.0%
1
   0.3%
5
   0.6%
Czech Republic Number Analyzed 386 participants 385 participants 771 participants
13
   3.4%
8
   2.1%
21
   2.7%
Hungary Number Analyzed 386 participants 385 participants 771 participants
16
   4.1%
16
   4.2%
32
   4.2%
Poland Number Analyzed 386 participants 385 participants 771 participants
78
  20.2%
85
  22.1%
163
  21.1%
Serbia Number Analyzed 386 participants 385 participants 771 participants
11
   2.8%
18
   4.7%
29
   3.8%
Slovakia Number Analyzed 386 participants 385 participants 771 participants
5
   1.3%
8
   2.1%
13
   1.7%
Bosnia Number Analyzed 386 participants 385 participants 771 participants
2
   0.5%
1
   0.3%
3
   0.4%
Bulgaria Number Analyzed 386 participants 385 participants 771 participants
10
   2.6%
6
   1.6%
16
   2.1%
Croatia Number Analyzed 386 participants 385 participants 771 participants
11
   2.8%
5
   1.3%
16
   2.1%
Israel Number Analyzed 386 participants 385 participants 771 participants
9
   2.3%
13
   3.4%
22
   2.9%
Romania Number Analyzed 386 participants 385 participants 771 participants
6
   1.6%
6
   1.6%
12
   1.6%
Russia Number Analyzed 386 participants 385 participants 771 participants
41
  10.6%
44
  11.4%
85
  11.0%
Turkey Number Analyzed 386 participants 385 participants 771 participants
9
   2.3%
5
   1.3%
14
   1.8%
Ukraine Number Analyzed 386 participants 385 participants 771 participants
26
   6.7%
39
  10.1%
65
   8.4%
Canada Number Analyzed 386 participants 385 participants 771 participants
18
   4.7%
20
   5.2%
38
   4.9%
United States Number Analyzed 386 participants 385 participants 771 participants
42
  10.9%
29
   7.5%
71
   9.2%
Argentina Number Analyzed 386 participants 385 participants 771 participants
1
   0.3%
3
   0.8%
4
   0.5%
Colombia Number Analyzed 386 participants 385 participants 771 participants
2
   0.5%
2
   0.5%
4
   0.5%
Mexico Number Analyzed 386 participants 385 participants 771 participants
9
   2.3%
3
   0.8%
12
   1.6%
France Number Analyzed 386 participants 385 participants 771 participants
4
   1.0%
6
   1.6%
10
   1.3%
Germany Number Analyzed 386 participants 385 participants 771 participants
3
   0.8%
6
   1.6%
9
   1.2%
Italy Number Analyzed 386 participants 385 participants 771 participants
9
   2.3%
11
   2.9%
20
   2.6%
Latvia Number Analyzed 386 participants 385 participants 771 participants
6
   1.6%
7
   1.8%
13
   1.7%
Lithuania Number Analyzed 386 participants 385 participants 771 participants
7
   1.8%
7
   1.8%
14
   1.8%
Portugal Number Analyzed 386 participants 385 participants 771 participants
9
   2.3%
4
   1.0%
13
   1.7%
United Kingdom Number Analyzed 386 participants 385 participants 771 participants
2
   0.5%
3
   0.8%
5
   0.6%
Denmark Number Analyzed 386 participants 385 participants 771 participants
8
   2.1%
3
   0.8%
11
   1.4%
Belgium Number Analyzed 386 participants 385 participants 771 participants
0
   0.0%
1
   0.3%
1
   0.1%
Netherlands Number Analyzed 386 participants 385 participants 771 participants
1
   0.3%
0
   0.0%
1
   0.1%
Spain Number Analyzed 386 participants 385 participants 771 participants
1
   0.3%
0
   0.0%
1
   0.1%
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 386 participants 383 participants 769 participants
170.5  (9.65) 172.0  (9.90) 171.3  (9.79)
[1]
Measure Analysis Population Description: Number analyzed are participants with data available for height.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 386 participants 383 participants 769 participants
73.43  (18.374) 72.67  (16.952) 73.05  (17.673)
[1]
Measure Analysis Population Description: Number analyzed are participants with data available for weight.
Body Mass Index (BMI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 386 participants 383 participants 769 participants
25.17  (5.646) 24.46  (4.786) 24.82  (5.244)
[1]
Measure Description: BMI is calculated from the weight taken prior to the first dose of study drug and height taken at Screening using formula, Body Mass Index = weight/[height]^2.
[2]
Measure Analysis Population Description: Number analyzed are participants with data available for BMI.
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 385 participants 771 participants
Has Never Smoked
259
  67.1%
280
  72.7%
539
  69.9%
Is a Current Smoker
23
   6.0%
19
   4.9%
42
   5.4%
Is an Ex-smoker
104
  26.9%
84
  21.8%
188
  24.4%
Missing
0
   0.0%
2
   0.5%
2
   0.3%
Female Reproductive Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 151 participants 321 participants
Postmenopausal
29
  17.1%
32
  21.2%
61
  19.0%
Surgically Sterile
18
  10.6%
17
  11.3%
35
  10.9%
Female of Childbearing Potential
123
  72.4%
102
  67.5%
225
  70.1%
[1]
Measure Analysis Population Description: Number analyzed are female participants.
1.Primary Outcome
Title Percentage of Participants Who Achieved Clinical Remission
Hide Description Clinical remission was defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was 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
Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg
Hide Arm/Group Description:
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
Overall Number of Participants Analyzed 386 383
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.5
(18.5 to 27.0)
31.3
(26.7 to 36.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab SC, 160/80/40 mg, Vedolizumab IV 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
2.5 to 15.0
Estimation Comments [Not Specified]
Other Statistical Analysis P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was <=5.
2.Secondary Outcome
Title Percentage of Participants Who Achieved Mucosal Healing
Hide Description Mucosal healing was defined as a Mayo score endoscopic subscore of <= 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was 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
FAS included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg
Hide Arm/Group Description:
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
Overall Number of Participants Analyzed 386 383
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.7
(23.3 to 32.5)
39.7
(34.8 to 44.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab SC, 160/80/40 mg, Vedolizumab IV 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
5.3 to 18.5
Estimation Comments [Not Specified]
Other Statistical Analysis P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was <=5.
3.Secondary Outcome
Title Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission
Hide Description Corticosteroid-free remission was defined as participants using oral corticosteroids at Baseline (Week 0) who had discontinued oral corticosteroids and were in clinical remission at Week 52. Clinical remission was defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was 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
Particiopants from, FAS, included all randomized participants who received at least 1 dose of study drug who used who used oral corticosteroids at Baseline.
Arm/Group Title Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg
Hide Arm/Group Description:
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
Overall Number of Participants Analyzed 119 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.8
(14.8 to 30.4)
12.6
(7.1 to 20.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab SC, 160/80/40 mg, Vedolizumab IV 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0641
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -9.3
Confidence Interval (2-Sided) 95%
-18.9 to 0.4
Estimation Comments [Not Specified]
Other Statistical Analysis P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was <=5.
Time Frame From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
 
Arm/Group Title Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg
Hide Arm/Group Description Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
All-Cause Mortality
Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/386 (0.00%)   1/383 (0.26%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   53/386 (13.73%)   42/383 (10.97%) 
Blood and lymphatic system disorders     
Anaemia  1  4/386 (1.04%)  1/383 (0.26%) 
Cardiac disorders     
Angina pectoris  1  0/386 (0.00%)  1/383 (0.26%) 
Myocardial ischaemia  1  1/386 (0.26%)  0/383 (0.00%) 
Pericarditis  1  0/386 (0.00%)  1/383 (0.26%) 
Eye disorders     
Blindness  1  0/386 (0.00%)  1/383 (0.26%) 
Gastrointestinal disorders     
Large intestine polyp  1  1/386 (0.26%)  0/383 (0.00%) 
Colitis ulcerative  1 [1]  25/386 (6.48%)  19/383 (4.96%) 
Colitis  1  1/386 (0.26%)  0/383 (0.00%) 
Inflammatory bowel disease  1  1/386 (0.26%)  0/383 (0.00%) 
Diarrhoea  1  0/386 (0.00%)  2/383 (0.52%) 
Small intestinal obstruction  1  0/386 (0.00%)  1/383 (0.26%) 
Abdominal pain  1  1/386 (0.26%)  3/383 (0.78%) 
Ileus  1  0/386 (0.00%)  1/383 (0.26%) 
Inguinal hernia  1  1/386 (0.26%)  1/383 (0.26%) 
Peritoneal haemorrhage  1  1/386 (0.26%)  0/383 (0.00%) 
Proctitis  1  0/386 (0.00%)  1/383 (0.26%) 
Umbilical hernia  1  1/386 (0.26%)  0/383 (0.00%) 
Incarcerated umbilical hernia  1  1/386 (0.26%)  0/383 (0.00%) 
General disorders     
Therapeutic response decreased  1  1/386 (0.26%)  0/383 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  1/386 (0.26%)  0/383 (0.00%) 
Infections and infestations     
Appendicitis  1  1/386 (0.26%)  1/383 (0.26%) 
Anal abscess  1  1/386 (0.26%)  0/383 (0.00%) 
Clostridium difficile colitis  1  0/386 (0.00%)  1/383 (0.26%) 
Clostridium difficile infection  1  0/386 (0.00%)  1/383 (0.26%) 
Cytomegalovirus infection  1  1/386 (0.26%)  3/383 (0.78%) 
Liver abscess  1  1/386 (0.26%)  0/383 (0.00%) 
Varicella  1  1/386 (0.26%)  0/383 (0.00%) 
Wound infection  1  1/386 (0.26%)  0/383 (0.00%) 
Pneumonia  1  2/386 (0.52%)  0/383 (0.00%) 
Gastroenteritis viral  1  0/386 (0.00%)  1/383 (0.26%) 
Injury, poisoning and procedural complications     
Traumatic haemothorax  1  1/386 (0.26%)  0/383 (0.00%) 
Ankle fracture  1  1/386 (0.26%)  0/383 (0.00%) 
Stab wound  1  1/386 (0.26%)  0/383 (0.00%) 
Post procedural complication  1  0/386 (0.00%)  1/383 (0.26%) 
Thoracic vertebral fracture  1  0/386 (0.00%)  1/383 (0.26%) 
Gamma-glutamyltransferase increased  1  1/386 (0.26%)  1/383 (0.26%) 
Investigations     
Alanine aminotransferase increased  1  0/386 (0.00%)  1/383 (0.26%) 
Aspartate aminotransferase increased  1  0/386 (0.00%)  1/383 (0.26%) 
Blood alkaline phosphatase increased  1  1/386 (0.26%)  0/383 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  1/386 (0.26%)  0/383 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/386 (0.00%)  2/383 (0.52%) 
Muscular weakness  1  1/386 (0.26%)  0/383 (0.00%) 
Pain in extremity  1  1/386 (0.26%)  0/383 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  0/386 (0.00%)  1/383 (0.26%) 
Nervous system disorders     
Brain stem haemorrhage  1  1/386 (0.26%)  0/383 (0.00%) 
Cerebrovascular accident  1  1/386 (0.26%)  0/383 (0.00%) 
Dysgraphia  1  0/386 (0.00%)  1/383 (0.26%) 
Seizure  1  0/386 (0.00%)  1/383 (0.26%) 
Nerve root compression  1  0/386 (0.00%)  2/383 (0.52%) 
Psychiatric disorders     
Major depression  1  0/386 (0.00%)  1/383 (0.26%) 
Renal and urinary disorders     
Acute kidney injury  1  1/386 (0.26%)  0/383 (0.00%) 
Ureterolithiasis  1  0/386 (0.00%)  1/383 (0.26%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/386 (0.26%)  0/383 (0.00%) 
Pneumothorax spontaneous  1  0/386 (0.00%)  1/383 (0.26%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/386 (0.00%)  1/383 (0.26%) 
Psoriasis  1  1/386 (0.26%)  0/383 (0.00%) 
Vascular disorders     
Hypovolaemic shock  1  1/386 (0.26%)  0/383 (0.00%) 
Thrombophlebitis superficial  1  1/386 (0.26%)  1/383 (0.26%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
[1]
One treatment-emergent death occurred during treatment with Vedolizumab IV 300 mg and was not related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adalimumab SC, 160/80/40 mg Vedolizumab IV 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   114/386 (29.53%)   103/383 (26.89%) 
Blood and lymphatic system disorders     
Anaemia  1  23/386 (5.96%)  19/383 (4.96%) 
Gastrointestinal disorders     
Colitis ulcerative  1  42/386 (10.88%)  26/383 (6.79%) 
Infections and infestations     
Nasopharyngitis  1  30/386 (7.77%)  27/383 (7.05%) 
Upper respiratory tract infection  1  17/386 (4.40%)  20/383 (5.22%) 
Nervous system disorders     
Headache  1  21/386 (5.44%)  27/383 (7.05%) 
1
Term from vocabulary, MedDRA 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: NCT02497469     History of Changes
Other Study ID Numbers: MLN0002-3026
U1111-1168-6713 ( Registry Identifier: WHO )
2015-000939-33 ( EudraCT Number )
NL54690.056.15 ( Registry Identifier: CCMO )
First Submitted: July 10, 2015
First Posted: July 14, 2015
Results First Submitted: September 17, 2019
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019