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

• 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: Janssen Research & Development, LLC
• 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

Participant Flow

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
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

Baseline Characteristics

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
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
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%

Outcome Measures

1. Primary Outcome

Title	Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)
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

Outcome Measure Data

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
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%

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.

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)
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

Outcome Measure Data

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
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%

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.

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)
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

Outcome Measure Data

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)
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%

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.

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)
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

Outcome Measure Data

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)
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%

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.

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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)
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

Outcome Measure Data

Analysis Population Description

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)
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)
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

Outcome Measure Data

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)
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)
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

Outcome Measure Data

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)
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)
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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 38.1%
Week 28:1-2 stools more than normal	53 30.3%	64 37.2%	76 43.2%
Week 28: 3-4 stools more than normal	34 19.4%	24 14.0%	22 12.5%
Week 28: 5 or more stools more than normal	36 20.6%	20 11.6%	11 6.3%
Week 32:Normal number of stools	51 29.1%	59 34.3%	72 40.9%
Week 32:1-2 stools more than normal	55 31.4%	66 38.4%	73 41.5%
Week 32: 3-4 stools more than normal	35 20.0%	25 14.5%	18 10.2%
Week 32: 5 or more stools more than normal	34 19.4%	22 12.8%	13 7.4%
Week 36:Normal number of stools	49 28.0%	59 34.3%	77 43.8%
Week 36:1-2 stools more than normal	52