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 : May 25, 2022
|
Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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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 |
Participant Flow
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 |
---|---|---|---|---|
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.
|
Baseline Characteristics
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 | |
---|---|---|---|---|---|---|
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 | |
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.
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Medical Director |
Organization: | Takeda |
Phone: | +1-877-825-3327 |
EMail: | trialdisclosures@takeda.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | May 25, 2022 |