We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

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: NCT02611817
Recruitment Status : Completed
First Posted : November 23, 2015
Results First Posted : June 23, 2020
Last Update Posted : May 25, 2022
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 Crohn's Disease
Interventions Drug: Vedolizumab SC 108 mg
Drug: Placebo
Drug: Vedolizumab IV 300 mg
Enrollment 644
Recruitment Details Participants with moderate to severe Crohn's disease (CD) took part in the study at 169 investigative sites in North America, South America, Western/Northern Europe, Central Europe, Eastern Europe, East Asia, and Africa/Australia from 04 Jan 2016 to 06 Aug 2019.
Pre-assignment Details Participants were enrolled in open-label (OL) induction phase to receive vedolizumab (VDZ) intravenous (IV). Participants with clinical response (CR) at Week 6 were randomized into double-blind maintenance phase to receive VDZ subcutaneous/placebo, and who did not achieve CR at Week 6 received 3rd infusion of OL VDZ IV 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
Hide Arm/Group Description Vedolizumab 300 milligram (mg), infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase. Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who 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. Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Period Title: Open-label Induction Phase
Started 644 0 0
Completed [1] 594 0 0
Not Completed 50 0 0
Reason Not Completed
Reason not Specified             9             0             0
Lack of Efficacy             8             0             0
Pregnancy             1             0             0
Withdrawal by Subject             9             0             0
Lost to Follow-up             2             0             0
Protocol Violation             5             0             0
Adverse Event             16             0             0
[1]
Completers included participants who received OL vedolizumab IV and had Week 14 visit.
Period Title: Double-blind Maintenance Phase
Started [1] 0 135 275
Completed 0 73 168
Not Completed 0 62 107
Reason Not Completed
Adverse Event             0             12             11
Randomized but not Treated             0             1             0
Reason not Specified             0             1             2
Lack of Efficacy             0             43             78
Pregnancy             0             0             1
Withdrawal by Subject             0             5             14
Lost to Follow-up             0             0             1
[1]
Participants who achieved clinical response at Week 6 entered the Maintenance Phase.
Arm/Group Title Induction Phase Only: Vedolizumab 300 mg IV Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Total
Hide Arm/Group Description Vedolizumab 300 mg, infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase Participants who did not achieve clinical response at Week 6 received third infusion of vedolizumab 300 mg IV on Week 6. Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who 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. Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase. Total of all reporting groups
Overall Number of Baseline Participants 235 134 275 644
Hide Baseline Analysis Population Description
The safety analysis set-combined (SAF-C) included all participants who received at least 1 dose of study vedolizumab IV.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 235 participants 134 participants 275 participants 644 participants
37.4  (12.79) 36.1  (12.93) 38.2  (13.85) 37.5  (13.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants 134 participants 275 participants 644 participants
Female
119
  50.6%
68
  50.7%
118
  42.9%
305
  47.4%
Male
116
  49.4%
66
  49.3%
157
  57.1%
339
  52.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants 134 participants 275 participants 644 participants
Hispanic or Latino
0
   0.0%
1
   0.7%
2
   0.7%
3
   0.5%
Not Hispanic or Latino
50
  21.3%
20
  14.9%
60
  21.8%
130
  20.2%
Unknown or Not Reported
185
  78.7%
113
  84.3%
213
  77.5%
511
  79.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants 134 participants 275 participants 644 participants
American Indian or Alaska Native
0
   0.0%
2
   1.5%
0
   0.0%
2
   0.3%
Asian
23
   9.8%
6
   4.5%
17
   6.2%
46
   7.1%
Native Hawaiian or Other Pacific Islander
2
   0.9%
1
   0.7%
0
   0.0%
3
   0.5%
Black or African American
3
   1.3%
1
   0.7%
7
   2.5%
11
   1.7%
White
207
  88.1%
124
  92.5%
250
  90.9%
581
  90.2%
More than one race
0
   0.0%
0
   0.0%
1
   0.4%
1
   0.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 235 participants 134 participants 275 participants 644 participants
69.94  (18.403) 69.79  (18.103) 74.08  (18.994) 71.68  (18.684)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 235 participants 134 participants 275 participants 644 participants
24.20  (6.073) 23.93  (5.541) 25.06  (5.915) 24.51  (5.909)
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants 134 participants 275 participants 644 participants
Never smoked
140
  59.6%
85
  63.4%
148
  53.8%
373
  57.9%
Current smoker
49
  20.9%
26
  19.4%
54
  19.6%
129
  20.0%
Ex-smoker
46
  19.6%
23
  17.2%
73
  26.5%
142
  22.0%
1.Primary Outcome
Title Percentage of Participants Achieving Clinical Remission at Week 52
Hide Description Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS): All randomized participants who received at least 1 dose of study SC drug (placebo or VDZ). Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in FAS. Participants in this set were analyzed according to the treatment they were randomized to receive.
Arm/Group Title Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Hide Arm/Group Description:
Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who 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.
Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Overall Number of Participants Analyzed 134 275
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.3
(26.3 to 43.0)
48.0
(42.0 to 54.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by electronic data capture (EDC) stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Clopper-Pearson method
Estimated Value 13.7
Confidence Interval (2-Sided) 95%
3.8 to 23.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Enhanced Clinical Response at Week 52
Hide Description Enhanced clinical response is defined as a decrease from Baseline of greater than or equal to (>=) 100 points in the CDAI score at Week 52. A CDAI is a multi-item instrument which measures severity of active CD monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
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 SC drug (placebo or VDZ). Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in FAS. Participants in this set were analyzed according to the treatment they were randomized to receive.
Arm/Group Title Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Hide Arm/Group Description:
Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who 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.
Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Overall Number of Participants Analyzed 134 275
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.8
(36.2 to 53.6)
52.0
(45.9 to 58.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Clopper-Pearson method
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
-3.0 to 17.5
Estimation Comments [Not Specified]
3.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 CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating 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 had all participants who received at least 1 dose of SC drug. Participants 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
Hide Arm/Group Description:
Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who 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.
Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Overall Number of Participants Analyzed 44 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.2
(8.2 to 32.7)
45.3
(35.0 to 55.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Clopper-Pearson method
Estimated Value 27.1
Confidence Interval (2-Sided) 95%
11.9 to 42.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
Hide Description Clinical remission is defined as CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from FAS, who were TNF-alpha antagonist naïve and had clinical remission. FAS had all participants who received at least 1 dose of SC drug. Participants who only received induction IV therapy and were not randomized in 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
Hide Arm/Group Description:
Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who 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.
Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Overall Number of Participants Analyzed 63 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.9
(30.5 to 56.0)
48.6
(38.8 to 58.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Induction IV + Placebo, Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Comments P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.591
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Clopper-Pearson method
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-11.6 to 20.3
Estimation Comments [Not Specified]
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68)
Adverse Event Reporting Description At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.
 
Arm/Group Title Induction Phase Only: Vedolizumab 300 mg IV Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Hide Arm/Group Description Vedolizumab 300 mg, infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase Participants who did not achieve clinical response at Week 6 received third infusion of vedolizumab 300 mg IV on Week 6. Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who 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. Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
All-Cause Mortality
Induction Phase Only: Vedolizumab 300 mg IV Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/235 (0.00%)      0/134 (0.00%)      0/275 (0.00%)    
Hide Serious Adverse Events
Induction Phase Only: Vedolizumab 300 mg IV Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/235 (16.60%)      14/134 (10.45%)      23/275 (8.36%)    
Blood and lymphatic system disorders       
Anaemias  1  1/235 (0.43%)  1 1/134 (0.75%)  1 1/275 (0.36%)  2
Leukocytosis  1  0/235 (0.00%)  0 1/134 (0.75%)  1 0/275 (0.00%)  0
Febrile neutropenia  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Cardiac disorders       
Angina pectoris  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Atrial fibrillation  1  0/235 (0.00%)  0 0/134 (0.00%)  0 2/275 (0.73%)  2
Gastrointestinal disorders       
Pancreatitis  1  0/235 (0.00%)  0 1/134 (0.75%)  1 0/275 (0.00%)  0
Crohn's disease  1  14/235 (5.96%)  14 5/134 (3.73%)  7 6/275 (2.18%)  7
Small intestinal obstruction  1  1/235 (0.43%)  1 2/134 (1.49%)  3 1/275 (0.36%)  1
Ileal stenosis  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Anal fistula  1  1/235 (0.43%)  1 1/134 (0.75%)  1 1/275 (0.36%)  1
Enterovesical fistula  1  0/235 (0.00%)  0 1/134 (0.75%)  1 0/275 (0.00%)  0
Intestinal obstruction  1  1/235 (0.43%)  1 0/134 (0.00%)  0 2/275 (0.73%)  2
Subileus  1  1/235 (0.43%)  1 0/134 (0.00%)  0 1/275 (0.36%)  1
Abdominal pain  1  2/235 (0.85%)  2 0/134 (0.00%)  0 0/275 (0.00%)  0
Enterocutaneous fistula  1  1/235 (0.43%)  2 0/134 (0.00%)  0 0/275 (0.00%)  0
Jejunal perforation  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Large intestinal ulcer  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Large intestine perforation  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Nausea  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Vomiting  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
General disorders       
General physical health deterioration  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Hepatobiliary disorders       
Hepatitis cholestatic  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Immune system disorders       
Anaphylactic reaction  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Infections and infestations       
Anal abscess  1  2/235 (0.85%)  2 1/134 (0.75%)  1 1/275 (0.36%)  1
Abdominal wall abscess  1  1/235 (0.43%)  1 1/134 (0.75%)  2 0/275 (0.00%)  0
Abscess intestinal  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Appendicitis  1  0/235 (0.00%)  0 1/134 (0.75%)  1 0/275 (0.00%)  0
Gastroenteritis  1  1/235 (0.43%)  1 1/134 (0.75%)  1 0/275 (0.00%)  0
Rectal abscess  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Dengue fever  1  0/235 (0.00%)  0 1/134 (0.75%)  1 0/275 (0.00%)  0
Bronchitis  1  0/235 (0.00%)  0 1/134 (0.75%)  1 0/275 (0.00%)  0
Pneumonia  1  1/235 (0.43%)  1 0/134 (0.00%)  0 1/275 (0.36%)  1
Abdominal abscess  1  4/235 (1.70%)  6 0/134 (0.00%)  0 0/275 (0.00%)  0
Cellulitis  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Colonic abscess  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Perirectal abscess  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Injury, poisoning and procedural complications       
Gastrointestinal anastomotic complication  1  1/235 (0.43%)  1 0/134 (0.00%)  0 1/275 (0.36%)  1
Incisional hernia  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Gastrointestinal anastomotic stenosis  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Infusion related reaction  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Investigations       
White blood cell count increased  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Metabolism and nutrition disorders       
Weight gain poor  1  0/235 (0.00%)  0 1/134 (0.75%)  1 0/275 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Intraductal papilloma of breast  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Nervous system disorders       
Haemorrhagic stroke  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Intraventricular haemorrhage  1  0/235 (0.00%)  0 1/134 (0.75%)  1 0/275 (0.00%)  0
Hemiparesis  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Hemiplegia  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
Psychiatric disorders       
Alcoholism  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Suicidal ideation  1  0/235 (0.00%)  0 0/134 (0.00%)  0 1/275 (0.36%)  1
Renal and urinary disorders       
Ureterolithiasis  1  1/235 (0.43%)  1 0/134 (0.00%)  0 0/275 (0.00%)  0
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction Phase Only: Vedolizumab 300 mg IV Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/235 (17.02%)      54/134 (40.30%)      102/275 (37.09%)    
Gastrointestinal disorders       
Crohn's disease  1  7/235 (2.98%)  7 23/134 (17.16%)  25 36/275 (13.09%)  36
Abdominal pain  1  9/235 (3.83%)  11 11/134 (8.21%)  14 21/275 (7.64%)  25
Nausea  1  9/235 (3.83%)  10 7/134 (5.22%)  7 11/275 (4.00%)  14
Vomiting  1  4/235 (1.70%)  5 7/134 (5.22%)  8 6/275 (2.18%)  7
Infections and infestations       
Nasopharyngitis  1  7/235 (2.98%)  8 6/134 (4.48%)  8 25/275 (9.09%)  26
Upper respiratory tract infection  1  2/235 (0.85%)  2 5/134 (3.73%)  6 17/275 (6.18%)  23
Musculoskeletal and connective tissue disorders       
Arthralgia  1  8/235 (3.40%)  8 9/134 (6.72%)  10 17/275 (6.18%)  21
Nervous system disorders       
Headache  1  10/235 (4.26%)  10 5/134 (3.73%)  9 15/275 (5.45%)  19
1
Term from vocabulary, MedDRA (22.0)
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: NCT02611817    
Other Study ID Numbers: MLN0002SC-3031
U1111-1168-0845 ( Registry Identifier: WHO )
2015-000481-58 ( EudraCT Number )
NL55774.056.16 ( Registry Identifier: CCMO )
16/LO/0090 ( Registry Identifier: NRES )
MLN0002SC-3031CTID ( Registry Identifier: Israel )
163300410A0045 ( Registry Identifier: NREC )
189748 ( Registry Identifier: HC-CTD )
MOH_2017-01-05_000039 ( Other Identifier: CRS )
JapicCTI-163386 ( Registry Identifier: JapicCTI )
First Submitted: November 19, 2015
First Posted: November 23, 2015
Results First Submitted: May 5, 2020
Results First Posted: June 23, 2020
Last Update Posted: May 25, 2022