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A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)

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: NCT02407236
Recruitment Status : Completed
First Posted : April 2, 2015
Results First Posted : December 23, 2019
Last Update Posted : January 5, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Conditions Colitis, Ulcerative
Inflammatory Bowel Diseases
Interventions Drug: Placebo IV
Drug: Placebo SC
Drug: Ustekinumab IV
Drug: Ustekinumab SC
Enrollment 961
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction Study(IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6mg/kg IV Maintenance Study(MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90mg SC Every 8 Weeks (q8w) MS: Placebo IV (IS - Responders) to Placebo SC MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w Long Term Extension (LTE): Placebo SC LTE: Ustekinumab 90 mg SC q12w LTE: Ustekinumab 90 mg SC q8w LTE: Placebo IV (IS - Responders) to Placebo SC LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w
Hide Arm/Group Description Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44. Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44. Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44. Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants). Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants). Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE). Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE. Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE. Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants). Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).
Period Title: Induction Study (8 Weeks)
Started 319 320 322 0 0 0 0 0 0 0 0 0 0
Completed 296 309 307 0 0 0 0 0 0 0 0 0 0
Not Completed 23 11 15 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             3             0             1             0             0             0             0             0             0             0             0             0             0
Death             0             0             1             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             17             9             7             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             0             0             1             0             0             0             0             0             0             0             0             0             0
Physician Decision             1             1             0             0             0             0             0             0             0             0             0             0             0
Other             2             1             5             0             0             0             0             0             0             0             0             0             0
Period Title: Maintenance Study (44 Weeks)
Started 0 0 0 175 172 176 103 157 0 0 0 0 0
Completed 0 0 0 132 148 158 76 128 0 0 0 0 0
Not Completed 0 0 0 43 24 18 27 29 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             19             8             4             11             10             0             0             0             0             0
Lack of Efficacy             0             0             0             19             9             6             12             12             0             0             0             0             0
Other             0             0             0             5             7             8             4             6             0             0             0             0             0
Death             0             0             0             0             0             0             0             1             0             0             0             0             0
Period Title: Long-term Extension Period (176 Weeks)
Started 0 0 0 0 0 0 0 0 115 141 143 73 116
Completed 0 0 0 0 0 0 0 0 34 99 101 0 95
Not Completed 0 0 0 0 0 0 0 0 81 42 42 73 21
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             9             17             10             11             9
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             1             0             0
Lack of Efficacy             0             0             0             0             0             0             0             0             9             6             12             7             6
Other             0             0             0             0             0             0             0             0             63             19             19             55             6
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6mg/kg IV Maintenance Study(MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90mg SC Every 8 Weeks (q8w) MS: Placebo IV (IS - Responders) to Placebo SC MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w Long Term Extension (LTE): Placebo SC LTE: Ustekinumab 90 mg SC q12w LTE: Ustekinumab 90 mg SC q8w LTE: Placebo IV (IS - Responders) to Placebo SC LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w Total
Hide Arm/Group Description Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44. Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44. Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44. Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants). Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants). Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE). Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE. Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE. Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants). Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants). Total of all reporting groups
Overall Number of Baseline Participants 319 320 322 0 0 0 0 0 0 0 0 0 0 961
Hide Baseline Analysis Population Description
The primary efficacy analysis set consisted of all participants randomized in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 319 participants 320 participants 322 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 961 participants
41.2  (13.50) 42.2  (13.94) 41.7  (13.67) 41.7  (13.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 319 participants 320 participants 322 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 961 participants
Female
122
  38.2%
130
  40.6%
127
  39.4%
0 0 0 0 0 0 0 0 0 0
379
  39.4%
Male
197
  61.8%
190
  59.4%
195
  60.6%
0 0 0 0 0 0 0 0 0 0
582
  60.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 319 participants 320 participants 322 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 961 participants
Hispanic or Latino
10
   3.1%
7
   2.2%
7
   2.2%
0 0 0 0 0 0 0 0 0 0
24
   2.5%
Not Hispanic or Latino
292
  91.5%
295
  92.2%
290
  90.1%
0 0 0 0 0 0 0 0 0 0
877
  91.3%
Unknown or Not Reported
17
   5.3%
18
   5.6%
25
   7.8%
0 0 0 0 0 0 0 0 0 0
60
   6.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 319 participants 320 participants 322 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 961 participants
American Indian or Alaska Native 0 0 1 1
Asian 48 46 49 143
Black or African American 3 6 0 9
Other 8 9 12 29
White 248 239 243 730
Unknown or Not Reported 12 20 17 49
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 319 participants 320 participants 322 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 961 participants
Australia
7
   2.2%
8
   2.5%
11
   3.4%
0 0 0 0 0 0 0 0 0 0
26
   2.7%
Austria
0
   0.0%
2
   0.6%
2
   0.6%
4
   0.4%
Belgium
22
   6.9%
10
   3.1%
7
   2.2%
39
   4.1%
Bulgaria
8
   2.5%
9
   2.8%
4
   1.2%
21
   2.2%
Canada
7
   2.2%
6
   1.9%
3
   0.9%
16
   1.7%
Czech Republic
8
   2.5%
9
   2.8%
13
   4.0%
0
30
   3.1%
Denmark
0
   0.0%
0
   0.0%
2
   0.6%
2
   0.2%
France
14
   4.4%
21
   6.6%
19
   5.9%
54
   5.6%
Germany
19
   6.0%
14
   4.4%
12
   3.7%
45
   4.7%
Hungary
11
   3.4%
12
   3.8%
16
   5.0%
0
39
   4.1%
Israel
0
   0.0%
3
   0.9%
3
   0.9%
0
6
   0.6%
Italy
10
   3.1%
11
   3.4%
12
   3.7%
33
   3.4%
Japan
34
  10.7%
34
  10.6%
39
  12.1%
107
  11.1%
Netherlands
5
   1.6%
8
   2.5%
3
   0.9%
16
   1.7%
New Zealand
4
   1.3%
4
   1.3%
11
   3.4%
19
   2.0%
Poland
25
   7.8%
26
   8.1%
20
   6.2%
71
   7.4%
Romania
7
   2.2%
9
   2.8%
8
   2.5%
24
   2.5%
Russia
26
   8.2%
22
   6.9%
26
   8.1%
74
   7.7%
Serbia
1
   0.3%
6
   1.9%
3
   0.9%
10
   1.0%
Slovakia
4
   1.3%
4
   1.3%
2
   0.6%
10
   1.0%
Ukraine
32
  10.0%
26
   8.1%
31
   9.6%
89
   9.3%
United Kingdom
5
   1.6%
3
   0.9%
13
   4.0%
21
   2.2%
United States
60
  18.8%
63
  19.7%
56
  17.4%
179
  18.6%
Korea
10
   3.1%
10
   3.1%
6
   1.9%
26
   2.7%
1.Primary Outcome
Title Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)
Hide Description As per global definition, clinical remission is defined as a Mayo score less than or equal to (<=)2 points, with no individual subscore greater than (>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding [RB], endoscopy findings, and physician's global assessment [PGA]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant ulcerative colitis (UC) medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis set (PEAS) consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
17
   5.3%
50
  15.6%
50
  15.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction Study (IS): Placebo Intravenous (IV), IS: Ustekinumab 130 Milligram (mg) IV
Comments Statistical Analysis 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted treatment difference
Estimated Value 10.3
Confidence Interval (2-Sided) 95%
5.7 to 14.9
Estimation Comments Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Induction Study (IS): Placebo Intravenous (IV), IS: Ustekinumab Approximately 6 mg/kg IV
Comments Statistical Analysis 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted treatment difference
Estimated Value 10.2
Confidence Interval (2-Sided) 95%
5.6 to 14.8
Estimation Comments Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.
2.Primary Outcome
Title Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition)
Hide Description As per US definition, clinical remission was defined as absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components pertaining to this outcome measure (OM) (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
20
   6.3%
53
  16.6%
61
  18.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction Study (IS): Placebo Intravenous (IV), IS: Ustekinumab 130 Milligram (mg) IV
Comments Statistical Analysis 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted treatment difference
Estimated Value 10.3
Confidence Interval (2-Sided) 97.5%
4.8 to 15.8
Estimation Comments Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Induction Study (IS): Placebo Intravenous (IV), IS: Ustekinumab Approximately 6 mg/kg IV
Comments Statistical Analysis 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted treatment difference
Estimated Value 12.7
Confidence Interval (2-Sided) 97.5%
7.0 to 18.4
Estimation Comments Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.
3.Primary Outcome
Title Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition)
Hide Description As per global definition, clinical remission was defined as a Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in UC medication or an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.
Time Frame Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC every 8 weeks (q8w), ustekinumab 90 mg SC every 12 weeks (q12w), or placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Measure Type: Count of Participants
Unit of Measure: Participants
42
  24.0%
66
  38.4%
77
  43.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study (MS): Placebo Subcutaneous (SC), MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)
Comments Statistical Analysis 1
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 Adjusted treatment difference
Estimated Value 14.5
Confidence Interval (2-Sided) 95%
5.5 to 23.6
Estimation Comments Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study (MS): Placebo Subcutaneous (SC), MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Comments Statistical Analysis 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted treatment difference
Estimated Value 19.7
Confidence Interval (2-Sided) 95%
10.3 to 29.0
Estimation Comments Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.
4.Primary Outcome
Title Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition)
Hide Description Per US definition, clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components pertaining to this OM (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Measure Type: Count of Participants
Unit of Measure: Participants
43
  24.6%
68
  39.5%
75
  42.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study (MS): Placebo Subcutaneous (SC), MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)
Comments Statistical Analysis 1
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 Adjusted treatment difference
Estimated Value 15.1
Confidence Interval (2-Sided) 95%
6.0 to 24.2
Estimation Comments Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study (MS): Placebo Subcutaneous (SC), MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Comments Statistical Analysis 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted treatment difference
Estimated Value 17.9
Confidence Interval (2-Sided) 95%
8.6 to 27.2
Estimation Comments Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.
5.Secondary Outcome
Title Induction Study: Number of Participants With Endoscopic Healing at Week 8
Hide Description Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
44
  13.8%
84
  26.3%
87
  27.0%
6.Secondary Outcome
Title Induction Study: Number of Participants With Clinical Response at Week 8
Hide Description Clinical response was defined as a decrease from induction baseline in the Mayo score by >=30 percent (%) and >= 3 points, with either a decrease from baseline in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
100
  31.3%
164
  51.2%
199
  61.8%
7.Secondary Outcome
Title Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Hide Description The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of event onward or participants who had missing IBDQ score at Week 8 had their last value carried forward.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure (OM).
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 317 316 321
Mean (Standard Deviation)
Unit of Measure: Units on a scale
16.1  (31.39) 33.4  (32.53) 35.0  (31.86)
8.Secondary Outcome
Title Maintenance Study: Number of Participants With Clinical Response up to Week 44
Hide Description Clinical response: decrease from induction baseline in Mayo score by >= 30% and >= 3 points, with either decrease from induction baseline in rectal bleeding subscore >=1 or rectal bleeding subscore of 0 or 1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5= mild; 6 to 10= moderate; 11 to 12= severe; higher scores indicate worsening of disease. Participants who lost clinical response at any time before Week 44, had prohibited change in UC medication, ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Up to Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Measure Type: Count of Participants
Unit of Measure: Participants
78
  44.6%
117
  68.0%
125
  71.0%
9.Secondary Outcome
Title Maintenance Study: Number of Participants With Endoscopic Healing at Week 44
Hide Description Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It was defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had prohibited change in UC medication, an ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Measure Type: Count of Participants
Unit of Measure: Participants
50
  28.6%
75
  43.6%
90
  51.1%
10.Secondary Outcome
Title Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition)
Hide Description Per global definition, clinical remission was defined as Mayo score <=2 points, with no individual subscore >1. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to have achieved OM of clinical remission and not receiving corticosteroids at Week 44. Participants who had missing value in corticosteroid use at Week 44 had their last value carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 44
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PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w/ placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Measure Type: Count of Participants
Unit of Measure: Participants
41
  23.4%
65
  37.8%
74
  42.0%
11.Secondary Outcome
Title Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition)
Hide Description US definition of clinical remission: absolute stool number <=3, rectal bleeding subscore 0 (no blood seen), Mayo endoscopy subscore of 0(normal or inactive disease)/ 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in corticosteroid-free clinical remission at Week 44. Participants with missing value in corticosteroid use at Week 44 had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame Week 44
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Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Measure Type: Count of Participants
Unit of Measure: Participants
42
  24.0%
67
  39.0%
72
  40.9%
12.Secondary Outcome
Title Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per Global Definition)
Hide Description Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Participants who were not in clinical remission at any time points when endoscopic scores were collected before Week 44 were considered not to be in clinical remission up to Week 44. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Up to Week 44
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Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 45 40 38
Measure Type: Count of Participants
Unit of Measure: Participants
17
  37.8%
26
  65.0%
22
  57.9%
13.Secondary Outcome
Title Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per US Definition)
Hide Description US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in clinical remission. Participants not in clinical remission at any time point when endoscopic scores collected before Week 44 considered not in clinical remission up to Week 44. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame Up to Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 48 52 44
Measure Type: Count of Participants
Unit of Measure: Participants
16
  33.3%
32
  61.5%
27
  61.4%
14.Secondary Outcome
Title Induction Study - Number of Participants With Mucosal Healing at Week 8
Hide Description Mucosal healing is defined as having both endoscopic healing (EH) and histologic healing (HH). Endoscopic healing: an endoscopy subscore of 0 (normal or inactive disease) or 1 mild disease ([erythema, decreased vascular pattern, mild friability]). Histologic healing: neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions or ulcerations or granulation tissue. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or had missing endoscopy score/ were missing any component of histologic healing (that is assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 8 or who had unevaluable biopsy (that is biopsy collected, but could not be assessed due to sample preparation or technical errors) at Week 8 but who did not achieve endoscopic healing, were considered not to have mucosal healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
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Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study, with participants whose mucosal healing status was determined at Week 8.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 316 316 315
Measure Type: Count of Participants
Unit of Measure: Participants
28
   8.9%
64
  20.3%
58
  18.4%
15.Secondary Outcome
Title Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition)
Hide Description As per global definition, clinical remission is defined as Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had missing rectal bleeding subscores at Week 8 were considered not to be in clinical remission with a rectal bleeding subscore of 0. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
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Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
17
   5.3%
49
  15.3%
49
  15.2%
16.Secondary Outcome
Title Induction Study - Number of Participants in Symptomatic Remission at Week 8
Hide Description Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 and/or both stool frequency and rectal bleeding subscores missing at Week 8 were considered not to be in symptomatic remission.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
72
  22.6%
132
  41.3%
144
  44.7%
17.Secondary Outcome
Title Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8
Hide Description Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have normal or inactive mucosal disease. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
12
   3.8%
33
  10.3%
25
   7.8%
18.Secondary Outcome
Title Induction Study - Change From Baseline in Mayo Score at Week 8
Hide Description The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline Mayo score carried forward to Week 8 or who had all 4 Mayo subscores missing at Week 8 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 321
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.8  (2.40) -3.2  (2.81) -3.5  (2.67)
19.Secondary Outcome
Title Induction Study - Change From Baseline in Partial Mayo Score Through Week 8
Hide Description The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 [normal] to 3 [severe]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants with the partial Mayo score missing at a timepoint had their last available individual partial Mayo subscore carried forward to that timepoint.
Time Frame Baseline through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 321
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 2 -1.0  (1.63) -1.5  (1.74) -1.6  (1.69)
Change at Week 4 -1.4  (1.86) -2.1  (1.86) -2.5  (1.93)
Change at Week 8 -1.5  (2.07) -2.6  (2.31) -2.9  (2.20)
20.Secondary Outcome
Title Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8
Hide Description The stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo stool frequency subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 321
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2:Normal number of stools
16
   5.0%
32
  10.0%
26
   8.1%
Week 2:1-2 stools more than normal
82
  25.7%
99
  30.9%
94
  29.3%
Week 2: 3-4 stools more than normal
85
  26.6%
88
  27.5%
90
  28.0%
Week 2: 5 or more stools more than normal
136
  42.6%
101
  31.6%
111
  34.6%
Week 4:Normal number of stools
30
   9.4%
36
  11.3%
50
  15.6%
Week 4:1-2 stools more than normal
85
  26.6%
122
  38.1%
126
  39.3%
Week 4: 3-4 stools more than normal
81
  25.4%
78
  24.4%
72
  22.4%
Week 4: 5 or more stools more than normal
123
  38.6%
84
  26.3%
73
  22.7%
Week 8:Normal number of stools
28
   8.8%
66
  20.6%
71
  22.1%
Week 8:1-2 stools more than normal
93
  29.2%
112
  35.0%
110
  34.3%
Week 8: 3-4 stools more than normal
76
  23.8%
61
  19.1%
85
  26.5%
Week 8: 5 or more stools more than normal
122
  38.2%
81
  25.3%
55
  17.1%
21.Secondary Outcome
Title Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8
Hide Description The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 = blood alone passed. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo rectal bleeding subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2: No blood seen
83
  26.0%
104
  32.5%
120
  37.3%
Week 2:Streaks of blood with stool < half time
119
  37.3%
122
  38.1%
131
  40.7%
Week 2: Obvious blood with stool most of the time
94
  29.5%
83
  25.9%
63
  19.6%
Week 2: Blood alone passed
23
   7.2%
11
   3.4%
8
   2.5%
Week 4:No blood seen
117
  36.7%
138
  43.1%
161
  50.0%
Week 4:Streaks of blood with stool < half time
103
  32.3%
117
  36.6%
115
  35.7%
Week 4: Obvious blood with stool most of time
75
  23.5%
54
  16.9%
40
  12.4%
Week 4: Blood alone passed
24
   7.5%
11
   3.4%
6
   1.9%
Week 8:No blood seen
119
  37.3%
173
  54.1%
204
  63.4%
Week 8:Streaks of blood with stool < half the time
106
  33.2%
85
  26.6%
81
  25.2%
Week 8: Obvious blood with stool most of the time
73
  22.9%
54
  16.9%
31
   9.6%
Week 8: Blood alone passed
21
   6.6%
8
   2.5%
6
   1.9%
22.Secondary Outcome
Title Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8
Hide Description The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo endoscopy subscore at Week 8 had the last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
Week 8: Normal or inactive disease
12
   3.8%
33
  10.3%
25
   7.8%
Week 8:Mild disease
32
  10.0%
51
  15.9%
62
  19.3%
Week 8: Moderate disease
99
  31.0%
96
  30.0%
84
  26.1%
Week 8: Severe disease
176
  55.2%
140
  43.8%
151
  46.9%
23.Secondary Outcome
Title Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8
Hide Description The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo physician's global assessment subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2: Normal
3
   0.9%
4
   1.3%
10
   3.1%
Week 2:Mild disease
66
  20.7%
82
  25.6%
81
  25.2%
Week 2: Moderate disease
194
  60.8%
193
  60.3%
181
  56.2%
Week 2: Severe disease
56
  17.6%
41
  12.8%
50
  15.5%
Week 4:Normal
13
   4.1%
14
   4.4%
22
   6.8%
Week 4:Mild disease
82
  25.7%
118
  36.9%
137
  42.5%
Week 4: Moderate disease
181
  56.7%
164
  51.2%
138
  42.9%
Week 4: Severe disease
43
  13.5%
24
   7.5%
25
   7.8%
Week 8:Normal
21
   6.6%
37
  11.6%
49
  15.2%
Week 8:Mild disease
83
  26.0%
136
  42.5%
135
  41.9%
Week 8: Moderate disease
153
  48.0%
115
  35.9%
106
  32.9%
Week 8: Severe disease
62
  19.4%
32
  10.0%
32
   9.9%
24.Secondary Outcome
Title Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition)
Hide Description Global definition of clinical remission: Mayo score<=2 points, with no individual subscore >1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score = sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores indicate worsening of disease. BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists and/or vedolizumab at dose approved for treatment of UC and did not respond initially or responded initially but lost response or were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis set consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with BF Number Analyzed 161 participants 164 participants 166 participants
2
   1.2%
19
  11.6%
21
  12.7%
Participants without BF Number Analyzed 158 participants 156 participants 156 participants
15
   9.5%
31
  19.9%
29
  18.6%
25.Secondary Outcome
Title Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition)
Hide Description US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores rated 0 (normal) to 3 (severe). BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, Mayo endoscopy subscore) at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review used endoscopy video.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with BF Number Analyzed 161 participants 164 participants 166 participants
4
   2.5%
19
  11.6%
22
  13.3%
Participants without BF Number Analyzed 158 participants 156 participants 156 participants
16
  10.1%
34
  21.8%
39
  25.0%
26.Secondary Outcome
Title Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status
Hide Description Number of participants with endoscopic healing at week 8 by BF status were reported. Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: Participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response/ were intolerant of medication. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with BF Number Analyzed 161 participants 164 participants 166 participants
11
   6.8%
30
  18.3%
35
  21.1%
Participants without BF Number Analyzed 158 participants 156 participants 156 participants
33
  20.9%
54
  34.6%
52
  33.3%
27.Secondary Outcome
Title Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status
Hide Description Clinical response: decrease from induction baseline in Mayo score by >=30% and >= 3 points, with either decrease from baseline in rectal bleeding subscore >=1/ rectal bleeding subscore= 0/1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores =worsening of disease. BF: participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with BF Number Analyzed 161 participants 164 participants 166 participants
44
  27.3%
74
  45.1%
95
  57.2%
Participants without BF Number Analyzed 158 participants 156 participants 156 participants
56
  35.4%
90
  57.7%
104
  66.7%
28.Secondary Outcome
Title Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)
Hide Description Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
25
   7.8%
60
  18.8%
67
  20.8%
29.Secondary Outcome
Title Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)
Hide Description Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
10
   3.1%
35
  10.9%
29
   9.0%
30.Secondary Outcome
Title Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8
Hide Description Change from baseline in CRP concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.
Time Frame Baseline through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 316 315 320
Median (Inter-Quartile Range)
Unit of Measure: milligram per liter (mg/L)
Change at Week 2
-0.01
(-2.79 to 1.21)
-0.75
(-4.53 to 0.00)
-0.92
(-6.24 to 0.05)
Change at Week 4
-0.18
(-3.12 to 0.71)
-1.08
(-5.86 to 0.00)
-1.94
(-7.16 to -0.06)
Change at Week 8
0.00
(-2.47 to 2.61)
-1.30
(-5.04 to 0.30)
-1.43
(-7.63 to 0.00)
31.Secondary Outcome
Title Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline
Hide Description Number of participants with normalized CRP (<=3 mg/L) up to Week 8 among participants with abnormal CRP (>3 mg/L) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing CRP value at the designated analysis timepoint were considered not to have normalized CRP.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study, with those participants who were having abnormal CRP at baseline.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 185 185 199
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2
36
  19.5%
54
  29.2%
58
  29.1%
Week 4
41
  22.2%
70
  37.8%
75
  37.7%
Week 8
39
  21.1%
63
  34.1%
77
  38.7%
32.Secondary Outcome
Title Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8
Hide Description Change from baseline in fecal lactoferrin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.
Time Frame Baseline through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 294 302 306
Median (Inter-Quartile Range)
Unit of Measure: microgram per gram (mcg/g)
Change at Week 2
0.00
(-103.22 to 120.67)
-4.67
(-140.04 to 75.46)
-24.06
(-202.88 to 60.23)
Change at Week 4
0.00
(-117.67 to 133.67)
-29.26
(-203.79 to 46.29)
-69.51
(-240.62 to 24.90)
Change at Week 8
-4.71
(-149.28 to 92.90)
-43.41
(-220.99 to 29.10)
-101.46
(-301.23 to 0.00)
33.Secondary Outcome
Title Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline
Hide Description Number of participants with normalized fecal lactoferrin (<=7.24 mcg/g) up to Week 8 among participants with abnormal fecal lactoferrin (> 7.24 mcg/g) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal lactoferrin value at the designated analysis timepoint were considered not to have normalized fecal lactoferrin.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study, with those participants who had abnormal fecal lactoferrin at baseline.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 280 291 294
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2
16
   5.7%
17
   5.8%
15
   5.1%
Week 4
16
   5.7%
37
  12.7%
33
  11.2%
Week 8
26
   9.3%
50
  17.2%
43
  14.6%
34.Secondary Outcome
Title Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8
Hide Description Change from baseline in fecal calprotectin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.
Time Frame Baseline through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 289 296 300
Median (Inter-Quartile Range)
Unit of Measure: milligram per kilogram (mg/kg)
Change at Week 2
0.00
(-702.00 to 631.00)
-29.00
(-933.50 to 492.00)
-127.00
(-1029.50 to 433.50)
Change at Week 4
-2.00
(-961.00 to 894.00)
-223.00
(-1200.50 to 266.50)
-485.50
(-1536.50 to 158.50)
Change at Week 8
-59.00
(-996.00 to 751.00)
-431.50
(-1635.50 to 175.00)
-715.50
(-1913.50 to 0.00)
35.Secondary Outcome
Title Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline
Hide Description Number of participants with normalized fecal calprotectin (<=250 milligram per kilogram [mg/kg) up to Week 8 among participants with abnormal fecal calprotectin (>250 mg/kg) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal calprotectin value at the designated analysis timepoint were considered not to have normalized fecal calprotectin.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all randomized participants in the induction study, with abnormal fecal calprotectin (>250 mg/kg) at baseline.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 250 264 274
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2
20
   8.0%
37
  14.0%
37
  13.5%
Week 4
25
  10.0%
45
  17.0%
47
  17.2%
Week 8
51
  20.4%
64
  24.2%
70
  25.5%
36.Secondary Outcome
Title Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Hide Description The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing IBDQ score at either baseline or Week 8 were considered not to have achieved a greater than 20-point improvement.
Time Frame Baseline and Week 8
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Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
118
  37.0%
196
  61.3%
200
  62.1%
37.Secondary Outcome
Title Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8
Hide Description The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward and participants who had missing IBDQ dimension score at designated analysis timepoint had their last value carried forward.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Bowel: Change at Week 8 Number Analyzed 317 participants 319 participants 321 participants
5.9  (10.34) 12.5  (11.27) 12.7  (11.11)
Emotional: Change at Week 8 Number Analyzed 317 participants 317 participants 321 participants
5.3  (12.33) 10.1  (12.39) 11.2  (12.33)
Systemic: Change at Week 8 Number Analyzed 317 participants 319 participants 321 participants
2.3  (5.59) 5.1  (5.59) 5.2  (5.65)
Social: Change at Week 8 Number Analyzed 317 participants 318 participants 321 participants
2.7  (6.55) 5.7  (7.41) 5.9  (6.44)
38.Secondary Outcome
Title Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8
Hide Description SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, physical component summary (PCS: calculated from subscales physical functioning, role-physical, bodily pain, and general health) and mental component summary (MCS: calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing component summary score at Week 8 had their last value carried forward.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Mean (Standard Deviation)
Unit of Measure: Units on a scale
PCS: Change at Week 8 Number Analyzed 319 participants 318 participants 322 participants
2.1  (6.39) 4.7  (6.49) 5.2  (6.16)
MCS: Change at Week 8 Number Analyzed 319 participants 318 participants 322 participants
2.2  (10.20) 5.3  (9.63) 5.1  (9.72)
39.Secondary Outcome
Title Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8
Hide Description SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing individual scale at a designated analysis timepoint had their last value carried forward.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 318 322
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Physical functioning: Change at Week 8 1.7  (6.46) 3.0  (6.46) 3.4  (6.51)
Role-physical: Change at Week 8 2.4  (9.51) 5.9  (9.34) 6.1  (8.53)
Bodily pain: Change at Week 8 2.6  (9.71) 6.0  (9.45) 6.8  (9.08)
General health: Change at Week 8 1.5  (7.36) 4.7  (7.74) 4.5  (7.10)
Vitality: Change at Week 8 2.7  (9.93) 6.1  (9.35) 6.8  (9.78)
Social functioning: Change at Week 8 3.0  (10.52) 6.6  (10.25) 6.4  (9.84)
Role-emotional: Change at Week 8 1.6  (11.04) 4.4  (11.04) 3.6  (10.53)
Mental health: Change at Week 8 2.0  (9.86) 4.7  (9.14) 5.1  (9.27)
40.Secondary Outcome
Title Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8
Hide Description EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 317 319 322
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.04  (0.182) 0.09  (0.182) 0.11  (0.172)
41.Secondary Outcome
Title Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8
Hide Description The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 317 319 322
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.71  (19.584) 13.64  (20.394) 13.51  (18.447)
42.Secondary Outcome
Title Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8
Hide Description EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.
Arm/Group Title Induction Study (IS): Placebo Intravenous (IV) IS: Ustekinumab 130 Milligram (mg) IV IS: Ustekinumab Approximately 6 mg/kg IV
Hide Arm/Group Description:
Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed 319 320 322
Measure Type: Number
Unit of Measure: Percentage of Participants
Mobility:Improved at Week 8 Number Analyzed 317 participants 319 participants 322 participants
18.0 16.3 24.2
Mobility:No change at Week 8 Number Analyzed 317 participants 319 participants 322 participants
71.9 71.8 66.8
Mobility:Worsened at Week 8 Number Analyzed 317 participants 319 participants 322 participants
10.1 11.9 9.0
Self-care:Improved at Week 8 Number Analyzed 317 participants 319 participants 322 participants
5.4 6.9 7.5
Self-care:No change at Week 8 Number Analyzed 317 participants 319 participants 322 participants
89.6 88.4 90.4
Self-care:Worsened at Week 8 Number Analyzed 317 participants 319 participants 322 participants
5.0 4.7 2.2
Usual activities:Improved at Week 8 Number Analyzed 317 participants 319 participants 322 participants
34.1 49.5 45.0
Usual activities:No Change at Week 8 Number Analyzed 317 participants 319 participants 322 participants
51.1 40.4 44.1
Usual activities:Worsened at Week 8 Number Analyzed 317 participants 319 participants 322 participants
14.8 10.0 10.9
Pain/discomfort: Improved at Week 8 Number Analyzed 319 participants 320 participants 322 participants
34.4 44.2 43.5
Pain/discomfort: No Change at Week 8 Number Analyzed 317 participants 319 participants 322 participants
49.8 48.3 48.1
Pain/discomfort: Worsened at Week 8 Number Analyzed 317 participants 319 participants 322 participants
15.8 7.5 8.4
Anxiety/depression: Improved at Week 8 Number Analyzed 317 participants 319 participants 322 participants
26.8 33.5 37.6
Anxiety/depression: No Change at Week 8 Number Analyzed 317 participants 319 participants 322 participants
55.5 54.2 51.6
Anxiety/depression: Worsened at Week 8 Number Analyzed 317 participants 319 participants 322 participants
17.7 12.2 10.9
43.Secondary Outcome
Title Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44
Hide Description The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy , or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to Week 44 had their Week 0 value of the induction study carried forward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Baseline and Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.6  (3.45) 0.1  (3.02) -0.5  (2.88)
44.Secondary Outcome
Title Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44
Hide Description The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total Mayo score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame Induction Baseline and Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.3  (3.34) -5.0  (3.27) -5.6  (3.17)
45.Secondary Outcome
Title Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44
Hide Description Stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.
Time Frame Up to Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.
Arm/Group Title Maintenance Study (MS): Placebo Subcutaneous (SC) MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w) MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Hide Arm/Group Description:
Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed 175 172 176
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4:Normal number of stools
56
  32.0%
61
  35.5%
58
  33.0%
Week 4:1-2 stools more than normal
91
  52.0%
76
  44.2%
86
  48.9%
Week 4: 3-4 stools more than normal
21
  12.0%
26
  15.1%
29
  16.5%
Week 4: 5 or more stools more than normal
7
   4.0%
9
   5.2%
3
   1.7%
Week 8:Normal number of stools
70
  40.0%
62
  36.0%
61
  34.7%
Week 8:1-2 stools more than normal
69
  39.4%
75
  43.6%
84
  47.7%
Week 8: 3-4 stools more than normal
22
  12.6%
25
  14.5%
26
  14.8%
Week 8: 5 or more stools more than normal
14
   8.0%
10
   5.8%
5
   2.8%
Week 12:Normal number of stools
62
  35.4%
55
  32.0%
64
  36.4%
Week 12:1-2 stools more than normal
72
  41.1%
75
  43.6%
85
  48.3%
Week 12: 3-4 stools more than normal
20
  11.4%
28
  16.3%
21
  11.9%
Week 12: 5 or more stools more than normal
21
  12.0%
14
   8.1%
6
   3.4%
Week 16:Normal number of stools
63
  36.0%
51
  29.7%
73
  41.5%
Week 16:1-2 stools more than normal
66
  37.7%
78
  45.3%
77
  43.8%
Week 16: 3-4 stools more than normal
25
  14.3%
27
  15.7%
15
   8.5%
Week 16: 5 or more stools more than normal
21
  12.0%
16
   9.3%
11
   6.3%
Week 20:Normal number of stools
59
  33.7%
63
  36.6%
67
  38.1%
Week 20:1-2 stools more than normal
55
  31.4%
65
  37.8%
85
  48.3%
Week 20: 3-4 stools more than normal
34
  19.4%
26
  15.1%
15
   8.5%
Week 20: 5 or more stools more than normal
27
  15.4%
18
  10.5%
9
   5.1%
Week 24:Normal number of stools
50
  28.6%
64
  37.2%
72
  40.9%
Week 24:1-2 stools more than normal
63
  36.0%
61
  35.5%
73
  41.5%
Week 24: 3-4 stools more than normal
31
  17.7%
31
  18.0%
20
  11.4%
Week 24: 5 or more stools more than normal
31
  17.7%
16
   9.3%
11
   6.3%
Week 28:Normal number of stools
52
  29.7%
64
  37.2%
67