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

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02407236
• Collaborator: (none)
• Enrollment: 961
• Locations: 254
• Arms: 10
• Actual Duration (Months): 76.1
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative; Inflammatory Bowel Diseases	Drug: Placebo IV; Drug: Placebo SC; Drug: Ustekinumab IV; Drug: Ustekinumab SC	Phase 3

Detailed Description

This is a Phase 3, randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), multi-center (more than one clinical site will work on a medical research study), protocol of ustekinumab. The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. Screening period will be up to 8 Weeks. Induction study will be at least 8 weeks duration for each participant. Participant with clinical response in the Induction study will be eligible for the Maintenance study. The Maintenance study will be 44 weeks duration. After completion of the maintenance study, a long term extension will follow eligible participants for an additional 3 years. Clinical remission will be evaluated at Week 8 in the Induction study. Clinical remission among ustekinumab Induction responders will be evaluated at week 44 in the Maintenance study. Participants' safety will be monitored throughout.

Study Design

• Study Type: Interventional
• Actual Enrollment: 961 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Induction Study - Placebo Intravenous (IV) Participants will be randomized to receive single dose of placebo as Intravenous (IV: into the vein) infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study, but will not be randomized.	Drug: Placebo IV; Placebo will be administered as intravenous infusion.
Experimental: Induction Study - Ustekinumab 130 milligram (mg) IV Participants will be randomized to receive single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.	Drug: Ustekinumab IV; Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Experimental: Induction Study - Ustekinumab 6 mg/kg IV Participants will be randomized to receive ustekinumab approximating 6 mg/kg of body weight, as intravenous infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.	Drug: Ustekinumab IV; Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Other: Induction Study- Placebo- Nonresponsders at Week 8 Participants without clinical response to placebo at Week 8 will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo (to maintain the blind). Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized.	Drug: Placebo SC; Placebo will be administered Subcutaneously.; Drug: Ustekinumab IV; Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Other: Induction study-Ustekinumab Nonresponders at Week 8 Participants without clinical response to ustekinumab (130 mg or 6 mg/kg [IV]) at Week 8 will receive a single dose of ustekinumab 90 mg subcutaneously along with matching placebo intravenously (to maintain the blind). Participants in clinical response at Week 16 (that is, delayed responders) will be eligible to enter Maintenance study, but will not be randomized.	Drug: Placebo IV; Placebo will be administered as intravenous infusion.; Drug: Ustekinumab SC; Ustekinumab will be administered as subcutaneously.
Placebo Comparator: Maintenance Study - Placebo Subcutaneous (SC) Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	Drug: Placebo SC; Placebo will be administered Subcutaneously.
Experimental: Maintenance Study - Ustekinumab 90mg SC every 12 weeks Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 12 weeks, beginning Week 0 of Maintenance study through Week 44.	Drug: Ustekinumab SC; Ustekinumab will be administered as subcutaneously.
Experimental: Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w) Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44.	Drug: Ustekinumab SC; Ustekinumab will be administered as subcutaneously.
Other: Maintenance Study - Placebo IV - Responder - Placebo SC Participants in clinical response to Induction treatment with IV Placebo will receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.	Drug: Placebo SC; Placebo will be administered Subcutaneously.
Other: Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w Participants without clinical response to induction treatment ustekinumab (130 mg or 6 mg/kg [IV]) at Week 8 but in clinical response at Week 16 after receiving Induction Ustekinumab at week 8 (delayed responders) will receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.	Drug: Ustekinumab SC; Ustekinumab will be administered as subcutaneously.

Outcome Measures

Primary Outcome Measures

1. Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition) [Week 8]

   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.

2. Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition) [Week 8]

   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.

3. Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition) [Week 44]

   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.

4. Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition) [Week 44]

   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.

Secondary Outcome Measures

1. Induction Study: Number of Participants With Endoscopic Healing at Week 8 [Week 8]

   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.

2. Induction Study: Number of Participants With Clinical Response at Week 8 [Week 8]

   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.

3. Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 [Baseline and Week 8]

   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.

4. Maintenance Study: Number of Participants With Clinical Response up to Week 44 [Up to Week 44]

   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.

5. Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 [Week 44]

   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.

6. Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition) [Week 44]

   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.

7. Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition) [Week 44]

   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.

8. 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) [Up to Week 44]

   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.

9. 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) [Up to Week 44]

   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.

10. Induction Study - Number of Participants With Mucosal Healing at Week 8 [Week 8]

    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.

11. Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition) [Week 8]

    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.

12. Induction Study - Number of Participants in Symptomatic Remission at Week 8 [Week 8]

    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.

13. Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8 [Week 8]

    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.

14. Induction Study - Change From Baseline in Mayo Score at Week 8 [Baseline and Week 8]

    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.

15. Induction Study - Change From Baseline in Partial Mayo Score Through Week 8 [Baseline through Week 8]

    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.

16. Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 [Up to Week 8]

    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.

17. Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 [Up to Week 8]

    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.

18. Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8 [Week 8]

    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.

19. Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 [Up to Week 8]

    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.

20. Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition) [Week 8]

    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.

21. Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition) [Week 8]

    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.

22. Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status [Week 8]

    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.

23. Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status [Week 8]

    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.

24. 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) [Week 8]

    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.

25. 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) [Week 8]

    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.

26. Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8 [Baseline through Week 8]

    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.

27. 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 [Up to Week 8]

    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.

28. Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8 [Baseline through Week 8]

    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.

29. 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 [Up to Week 8]

    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.

30. Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8 [Baseline through Week 8]

    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.

31. 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 [Up to Week 8]

    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.

32. Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 [Baseline and Week 8]

    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.

33. Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8 [Baseline and Week 8]

    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.

34. Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8 [Baseline and Week 8]

    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.

35. Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 [Baseline and Week 8]

    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.

36. Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8 [Baseline and Week 8]

    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.

37. Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8 [Baseline and Week 8]

    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.

38. Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 [Baseline and Week 8]

    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.

39. Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44 [Baseline and Week 44]

    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.

40. Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44 [Induction Baseline and Week 44]

    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.

41. Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 [Up to Week 44]

    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.

42. Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 [Up to Week 44]

    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 <half time, 2 = obvious blood with stool most of time, and 3 = blood alone passed. Higher scores = worsening of disease. Participants who had prohibited change in concomitant 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 before Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing Mayo subscores at timepoint had last available value for that subscore carried forward.

43. Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44 [Week 44]

    The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 =normal/ 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 = worsening of disease. Participants who had prohibited change in concomitant 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 had Week 0 value of induction study carried forward from time of event onward and who had missing endoscopy subscores at timepoint had last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

44. Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 [Up to Week 44]

    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, 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 and who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.

45. Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 [Baseline through Week 44]

    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, 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. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.

46. Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 [Baseline through Week 44]

    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, 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. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.

47. Maintenance 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 44 [Week 44]

    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 44 were reported. 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 and who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

48. Maintenance 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 44 [Week 44]

    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 44 were reported. 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 or who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

49. Maintenance Study: Number of Participants in Symptomatic Remission at Week 44 [Week 44]

    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, 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 were considered not to be in symptomatic remission from the time of the event onward. Participants who had both stool frequency and rectal bleeding subscores missing at Week 44 were considered not to be in symptomatic remission for that visit. Endoscopy subscore as assessed during central review of video of endoscopy was used.

50. Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition) [Week 44]

    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=worsening of disease. 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/ were intolerant of medication. 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 or who had all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.

51. Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition) [Week 44]

    US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore: 0 (no blood seen), Mayo endoscopy subscore: 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). BF: participants received 1/ more TNF antagonists/ vedolizumab for treatment of UC, not responded initially/ responded initially but lost response/ were intolerant of medicines. Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect /due to AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components (absolute stool number, rectal bleeding and endoscopy) at Week 44 were not in clinical remission. Endoscopy subscore assessed during central review used video of endoscopy.

52. Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status [Up to Week 44]

    Clinical response: decrease from IS baseline in Mayo score by >=30% and >=3 points, with either decrease from baseline in RB subscore >=1/ RB subscore of 0/ 1. Mayo score have 4 subscores (SF, RB, endoscopy findings, PGA), rated 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: 1/ more TNF antagonists/ vedolizumab for treating UC, no respond initially/responded initially but lost response/ medication intolerant. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsen UC before Week 44, had all 4 Mayo subscores miss at Week44/ lost clinical response at any time before Week44 were not in clinical response upto Week44. Endoscopy subscore assessed during central review used endoscopy video.

53. Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status [Week 44]

    Number of participants with endoscopic healing at week 44 by BF status were reported. Endoscopic healing is improvement in endoscopic appearance of 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 or more tumor necrosis factor (TNF) antagonists or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response, or were intolerant of medication. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy, or used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to 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.

54. Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline [Week 44]

    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, 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 a 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.

55. Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44 [Week 44]

    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, 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 a 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.

56. Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per Global Definition) [Week 44]

    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 0(normal) to 3(severe). Total score=sum of 4 subscores, range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. 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 considered not to achieved OM of clinical remission and not receiving concomitant corticosteroids (corticosteroid-free clinical remission). Participants with all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Participants missing value in corticosteroid use had their last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.

57. Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per US Definition) [Week 44]

    US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and Mayo endoscopy subscore of 0(normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number is average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated as 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 who were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and endoscopy subscore) at Week 44 were considered not in clinical remission. Participants with missing value in corticosteroid use had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.

58. MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline [Baseline Through Week 44]

    The change from maintenance baseline in average daily prednisone-equivalent (P.Eq) corticosteroid dose through Week 44 among the participants receiving concomitant corticosteroids other than budesonide and beclomethasone dipropionate at maintenance baseline was reported. 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 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing value in corticosteroid use at a timepoint had their last available value carried forward to that timepoint.

59. Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline [Week 44]

    Number of participants not receiving concomitant corticosteroids at Week 44 among participants who received concomitant corticosteroids at maintenance Baseline were reported. 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 considered to be receiving concomitant corticosteroids at Week 44. Participants who had a missing value in corticosteroid use at Week 44 had their last value carried forward.

60. Maintenance Study: Number of Participants Who Maintained 20-point Improvement From Induction Baseline in IBDQ up to Week 44 Among Participants With a >20-point Improvement in IBDQ at Maintenance Baseline [Up to Week 44]

    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 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 missing IBDQ score were considered not to have maintained improvement in IBDQ.

61. Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44 [Baseline, Week 20, and 44]

    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 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 prohibited change in concomitant UC medication or ostomy or colectomy prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing IBDQ score at a timepoint had their last value carried forward.

62. Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 [Baseline, Week 20, and 44]

    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); 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 44 had their Week 0 value of induction study carried forward from time of event onward and participants who had missing IBDQ dimension score at a timepoint had their last available value carried forward.

63. Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44 [Baseline, Weeks 20, and 44]

    SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, PCS (calculated from subscales physical functioning, role-physical, bodily pain, and general health) and 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 with prohibited change in concomitant 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 before Week 44 had Week 0 value of IS carried forward from time of event onward and participants with missing component summary score at timepoint had last available value carried forward.

64. Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 [Baseline, Weeks 20, and 44]

    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/ ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had Week 0 value of induction study carried forward from time of event onward and participants with missing individual scale score at timepoint had last available value carried forward.

65. Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44 [Baseline, Weeks 20, and 44]

    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 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 and participants who had a missing individual scale score at a timepoint had their last available value carried forward.

66. Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44 [Baseline, Weeks 20 and 44]

    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 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 and participants who had a missing VAS score at a timepoint had their last available value carried forward.

67. Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 [Baseline, Weeks 20, and 44]

    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/ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing individual scale score at timepoint had their last available value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.

68. Maintenance Study: Number of Participants With Mucosal Healing at Week 44 [Week 44]

    Mucosal healing included EH and HH. EH: endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). HH: neutrophil infiltration in <5% of crypts, no crypt destruction, no erosions/ ulcerations/ granulation tissue. Participants with prohibited change in concomitant 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/ missing endoscopy score/ missing any component of histologic healing (i.e. assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 44 and had unevaluable biopsy (biopsy collected but could not assessed due to sample preparation/ technical errors) at Week 44, but who did not achieve endoscopic healing, considered not to have mucosal healing. Endoscopy subscore assessed during central review used endoscopy video.

69. Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44 [Baseline, Weeks 8, 24, and 44]

    Change from Maintenance baseline in CRP concentration at Weeks 8, 24, and 44 were reported. 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. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.

70. Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44 [Baseline, Weeks 8, 24, and 44]

    Change from Maintenance baseline in fecal lactoferrin concentration at Weeks 8, 24, and 44 were reported. 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. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.

71. Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44 [Baseline, Weeks 8, 24, and 44]

    Change from Maintenance baseline in fecal calprotectin concentration at Weeks 8, 24, and 44 were reported. 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. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening

• Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (>=) 2 as determined by a central reading of the video endoscopy

• Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC)

• Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks

Exclusion Criteria:

• Has severe extensive colitis and is at imminent risk of colectomy

• Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon

• Presence of a stoma or history of a fistula

• Participants with history of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity

• Participants with history of colonic mucosal dysplasia. Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia''

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		La Mirada	California	United States
3		Los Angeles	California	United States
4		Newport Beach	California	United States
5		Torrance	California	United States
6		Vallejo	California	United States
7		Lone Tree	Colorado	United States
8		Farmington	Connecticut	United States
9		Washington	District of Columbia	United States
10		Gainesville	Florida	United States
11		Largo	Florida	United States
12		Miami	Florida	United States
13		Port Orange	Florida	United States
14		Tampa	Florida	United States
15		Winter Park	Florida	United States
16		Zephyrhills	Florida	United States
17		Atlanta	Georgia	United States
18		Decatur	Georgia	United States
19		Macon	Georgia	United States
20		Suwanee	Georgia	United States
21		Idaho Falls	Idaho	United States
22		Chicago	Illinois	United States
23		Evanston	Illinois	United States
24		Urbana	Illinois	United States
25		Indianapolis	Indiana	United States
26		Pratt	Kansas	United States
27		Crestview Hills	Kentucky	United States
28		Lexington	Kentucky	United States
29		Louisville	Kentucky	United States
30		Houma	Louisiana	United States
31		Shreveport	Louisiana	United States
32		Columbia	Maryland	United States
33		Boston	Massachusetts	United States
34		Ann Arbor	Michigan	United States
35		Chesterfield	Michigan	United States
36		Troy	Michigan	United States
37		Ypsilanti	Michigan	United States
38		Rochester	Minnesota	United States
39		Jackson	Mississippi	United States
40		Marlton	New Jersey	United States
41		Morristown	New Jersey	United States
42		Bronx	New York	United States
43		Brooklyn	New York	United States
44		Mineola	New York	United States
45		New York	New York	United States
46		Poughkeepsie	New York	United States
47		Rochester	New York	United States
48		Cincinnati	Ohio	United States
49		Mentor	Ohio	United States
50		Portland	Oregon	United States
51		Doylestown	Pennsylvania	United States
52		Hershey	Pennsylvania	United States
53		Philadelphia	Pennsylvania	United States
54		Sayre	Pennsylvania	United States
55		Germantown	Tennessee	United States
56		Nashville	Tennessee	United States
57		Dallas	Texas	United States
58		Houston	Texas	United States
59		Irving	Texas	United States
60		San Antonio	Texas	United States
61		Southlake	Texas	United States
62		Tyler	Texas	United States
63		Salt Lake City	Utah	United States
64		West Jordan	Utah	United States
65		Chesapeake	Virginia	United States
66		Fairfax	Virginia	United States
67		Roanoke	Virginia	United States
68		Seattle	Washington	United States
69		Bedford		Australia
70		Clayton		Australia
71		Concord N/a		Australia
72		Fitzroy		Australia
73		Five Dock		Australia
74		Garran		Australia
75		Heidelberg		Australia
76		Liverpool		Australia
77		Melbourne		Australia
78		South Brisbane		Australia
79		Salzburg		Austria
80		Wien		Austria
81		Antwerpen		Belgium
82		Gent		Belgium
83		Kortrijk		Belgium
84		Leuven		Belgium
85		Liege		Belgium
86		Liège		Belgium
87		Roeselaere		Belgium
88		Pleven		Bulgaria
89		Rousse		Bulgaria
90		Sevlievo		Bulgaria
91		Sofia		Bulgaria
92		Varna		Bulgaria
93		Vancouver	British Columbia	Canada
94		Victoria	British Columbia	Canada
95		Brandon	Manitoba	Canada
96		Winnipeg	Manitoba	Canada
97		London	Ontario	Canada
98		Sudbury	Ontario	Canada
99		Montreal	Quebec	Canada
100		Hradec Kralove		Czechia
101		Plzen		Czechia
102		Prague 4		Czechia
103		Praha 5		Czechia
104		Praha 7		Czechia
105		Praha 9		Czechia
106		Aarhus		Denmark
107		Odense		Denmark
108		Amiens		France
109		Bordeaux		France
110		Lille		France
111		Lyon		France
112		Marseille		France
113		Montpellier		France
114		Pierre-Benite		France
115		Reims		France
116		Rennes		France
117		Saint-Etienne		France
118		Toulouse		France
119		Berlin		Germany
120		Essen		Germany
121		Freiburg		Germany
122		Hannover		Germany
123		Kiel		Germany
124		Leipzig		Germany
125		Lüneburg		Germany
126		Mannheim		Germany
127		Minden		Germany
128		Münster		Germany
129		Balatonfüred		Hungary
130		Budapest		Hungary
131		Békéscsaba		Hungary
132		Debrecen		Hungary
133		Miskolc		Hungary
134		Mosonmagyarovar		Hungary
135		Szekszárd		Hungary
136		Szombathely		Hungary
137		Székesfehérvár		Hungary
138		Vac		Hungary
139		Beersheba		Israel
140		Haifa		Israel
141		Holon		Israel
142		Jerusalem		Israel
143		Kfar-Saba		Israel
144		Nahariya		Israel
145		Petach Tikvah		Israel
146		Tel Aviv		Israel
147		Tel Hashomer		Israel
148		Ageo-shi		Japan
149		Asahikawa		Japan
150		Bunkyo-Ku		Japan
151		Chiba		Japan
152		Chikushinoshi		Japan
153		Fujiidera		Japan
154		Fukuoka-ken		Japan
155		Higashi-Ibaraki		Japan
156		Hirosaki		Japan
157		Hiroshima		Japan
158		Isesaki		Japan
159		Iwate		Japan
160		Izumo		Japan
161		Kagawa		Japan
162		Kagoshima		Japan
163		Kahoku		Japan
164		Kobe-shi		Japan
165		Kochi		Japan
166		Kurume		Japan
167		Kyoto		Japan
168		Midori-ku		Japan
169		Nagasaki		Japan
170		Nara		Japan
171		Nishinomiya		Japan
172		Oita		Japan
173		Osaka		Japan
174		Saga-ken		Japan
175		Saga		Japan
176		Saitama		Japan
177		Sakura		Japan
178		Sapporo		Japan
179		Sendai		Japan
180		Shizuoka		Japan
181		Sunto-gun		Japan
182		Takamatsu		Japan
183		Tokorozawa		Japan
184		Tokyo		Japan
185		Toyama		Japan
186		Toyota		Japan
187		Tsuchiura		Japan
188		Tsu		Japan
189		Wakayama		Japan
190		Yamanashi		Japan
191		Daegu		Korea, Republic of
192		Guri-si		Korea, Republic of
193		Seoul		Korea, Republic of
194		Suwon-si		Korea, Republic of
195		Amsterdam		Netherlands
196		Maastricht		Netherlands
197		Auckland		New Zealand
198		Christchurch		New Zealand
199		Dunedin		New Zealand
200		Lower Hutt		New Zealand
201		Milford		New Zealand
202		Gdansk		Poland
203		Krakow		Poland
204		Lodz		Poland
205		Pulawy		Poland
206		Sopot		Poland
207		Szczecin		Poland
208		Warszawa		Poland
209		Wroclaw		Poland
210		Bucuresti		Romania
211		Oradea		Romania
212		Romania		Romania
213		Timisoara		Romania
214		Irkutsk		Russian Federation
215		Kazan		Russian Federation
216		Moscow		Russian Federation
217		Moscva		Russian Federation
218		Novosibirsk		Russian Federation
219		Rostov-on-Don		Russian Federation
220		Ryazan		Russian Federation
221		Saint Petersburg		Russian Federation
222		St Petersburg		Russian Federation
223		St.-Petersburg		Russian Federation
224		Stavropol		Russian Federation
225		Ufa		Russian Federation
226		Belgrade		Serbia
227		Kragujevac		Serbia
228		Nis		Serbia
229		Vojvodina		Serbia
230		Bratislava		Slovakia
231		Presov		Slovakia
232		Chernivtsi		Ukraine
233		Dnipropetrovsk		Ukraine
234		Ivano-Frankivsk		Ukraine
235		Kharkiv		Ukraine
236		Kiyv		Ukraine
237		Kyiv		Ukraine
238		Lviv		Ukraine
239		Odessa		Ukraine
240		Sumy		Ukraine
241		Uzhgorod		Ukraine
242		Vinnytsia		Ukraine
243		Zaporizhzhia		Ukraine
244		Zhaporozhia		Ukraine
245		Birmingham		United Kingdom
246		Cambridge		United Kingdom
247		Coventry		United Kingdom
248		Doncaster		United Kingdom
249		Edinburgh		United Kingdom
250		Liverpool		United Kingdom
251		London		United Kingdom
252		Salford		United Kingdom
253		Southampton		United Kingdom
254		Sutton In Ashfield		United Kingdom

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - Apr 20, 2016
• Statistical Analysis Plan - Jul 25, 2018

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT02407236
• Other Study ID Numbers: CR106920; 2014-005606-38; CNTO1275UCO3001
• First Posted: Apr 2, 2015
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Janssen Research & Development, LLC: Ustekinumab; Inflammatory Bowel Diseases (IBD); Colitis, Ulcerative
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Ustekinumab

Study Results

Participant Flow

Recruitment Details	Out of 961 randomized participants, 783 participants (523 randomized + 260 non-randomized) had clinical response in induction study and entered maintenance study (523 participants were considered as primary population for maintenance study).
Pre-assignment Detail	Per planned analysis, all efficacy outcome measures are based on the primary population for Maintenance study. Results are reported up to data cut-off date 12 Aug 2018.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)	MS: Placebo IV (IS - Responders) to Placebo SC	MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC 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 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.	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) received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).
Period Title: Induction Study (8 Weeks)
STARTED	319	320	322	0	0	0	0	0
Clinical Response at IS Week 8	103	172	208	0	0	0	0	0
Clinical Response at IS Week 16	143	90	67	0	0	0	0	0
Completed Safety Follow-up	50	47	32	0	0	0	0	0
Safety Analysis Set	319	321	320	0	0	0	0	0
Non-responders at Week 8	184	132	101	0	0	0	0	0
COMPLETED	296	309	307	0	0	0	0	0
NOT COMPLETED	23	11	15	0	0	0	0	0
Period Title: Induction Study (8 Weeks)
STARTED	0	0	0	175	172	176	103	157
COMPLETED	0	0	0	165	161	168	94	149
NOT COMPLETED	0	0	0	10	11	8	9	8

Baseline Characteristics

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)	MS: Placebo IV (IS - Responders) to Placebo SC	MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC 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 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 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.	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) received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Total of all reporting groups
Overall Participants	319	320	322	0	0	0	0	0	961
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.2 (13.50)	42.2 (13.94)	41.7 (13.67)	41.7 (13.70)
Sex: Female, Male (Count of Participants)
Female	122 38.2%	130 40.6%	127 39.4%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	379 39.4%
Male	197 61.8%	190 59.4%	195 60.6%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	582 60.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 3.1%	7 2.2%	7 2.2%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	24 2.5%
Not Hispanic or Latino	292 91.5%	295 92.2%	290 90.1%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	877 91.3%
Unknown or Not Reported	17 5.3%	18 5.6%	25 7.8%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	60 6.2%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 0.3%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	1 0.1%
Asian	48 15%	46 14.4%	49 15.2%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	143 14.9%
Black or African American	3 0.9%	6 1.9%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	9 0.9%
Other	8 2.5%	9 2.8%	12 3.7%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	29 3%
Unknown or Not Reported	12 3.8%	20 6.3%	17 5.3%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	49 5.1%
White	248 77.7%	239 74.7%	243 75.5%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	730 76%
Region of Enrollment (Count of Participants)
Australia	7 2.2%	8 2.5%	11 3.4%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	26 2.7%
Austria	0 0%	2 0.6%	2 0.6%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	4 0.4%
Belgium	22 6.9%	10 3.1%	7 2.2%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	39 4.1%
Bulgaria	8 2.5%	9 2.8%	4 1.2%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	21 2.2%
Canada	7 2.2%	6 1.9%	3 0.9%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	16 1.7%
Czech Republic	8 2.5%	9 2.8%	13 4%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	30 3.1%
Denmark	0 0%	0 0%	2 0.6%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	2 0.2%
France	14 4.4%	21 6.6%	19 5.9%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	54 5.6%
Germany	19 6%	14 4.4%	12 3.7%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	45 4.7%
Hungary	11 3.4%	12 3.8%	16 5%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	39 4.1%
Israel	0 0%	3 0.9%	3 0.9%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	6 0.6%
Italy	10 3.1%	11 3.4%	12 3.7%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	33 3.4%
Japan	34 10.7%	34 10.6%	39 12.1%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	107 11.1%
Netherlands	5 1.6%	8 2.5%	3 0.9%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	16 1.7%
New Zealand	4 1.3%	4 1.3%	11 3.4%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	19 2%
Poland	25 7.8%	26 8.1%	20 6.2%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	71 7.4%
Romania	7 2.2%	9 2.8%	8 2.5%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	24 2.5%
Russia	26 8.2%	22 6.9%	26 8.1%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	74 7.7%
Serbia	1 0.3%	6 1.9%	3 0.9%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	10 1%
Slovakia	4 1.3%	4 1.3%	2 0.6%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	10 1%
Ukraine	32 10%	26 8.1%	31 9.6%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	89 9.3%
United Kingdom	5 1.6%	3 0.9%	13 4%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	21 2.2%
United States	60 18.8%	63 19.7%	56 17.4%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	179 18.6%
Korea	10 3.1%	10 3.1%	6 1.9%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	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.
Measure Participants	319	320	322
Count of Participants [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
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 95%; 5.7 to 14.9
	Parameter Dispersion	Type: Value:
	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
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	10.2
	Confidence Interval	(2-Sided) 95%; 5.6 to 14.8
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	319	320	322
Count of Participants [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
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 97.5%; 4.8 to 15.8
	Parameter Dispersion	Type: Value:
	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
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	12.7
	Confidence Interval	(2-Sided) 97.5%; 7.0 to 18.4
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	175	172	176
Count of Participants [Participants]	42 13.2%	66 20.6%	77 23.9%

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
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	14.5
	Confidence Interval	(2-Sided) 95%; 5.5 to 23.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with 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
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	19.7
	Confidence Interval	(2-Sided) 95%; 10.3 to 29.0
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	175	172	176
Count of Participants [Participants]	43 13.5%	68 21.3%	75 23.3%

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
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	15.1
	Confidence Interval	(2-Sided) 95%; 6.0 to 24.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with 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
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	17.9
	Confidence Interval	(2-Sided) 95%; 8.6 to 27.2
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	319	320	322
Count of Participants [Participants]	44 13.8%	84 26.3%	87 27%

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.
Measure Participants	319	320	322
Count of Participants [Participants]	100 31.3%	164 51.3%	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.
Measure Participants	317	316	321
Mean (Standard Deviation) [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.
Measure Participants	175	172	176
Count of Participants [Participants]	78 24.5%	117 36.6%	125 38.8%

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.
Measure Participants	175	172	176
Count of Participants [Participants]	50 15.7%	75 23.4%	90 28%

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.
Measure Participants	175	172	176
Count of Participants [Participants]	41 12.9%	65 20.3%	74 23%

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.
Measure Participants	175	172	176
Count of Participants [Participants]	42 13.2%	67 20.9%	72 22.4%

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.
Measure Participants	45	40	38
Count of Participants [Participants]	17 5.3%	26 8.1%	22 6.8%

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.
Measure Participants	48	52	44
Count of Participants [Participants]	16 5%	32 10%	27 8.4%

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.
Measure Participants	316	316	315
Count of Participants [Participants]	28 8.8%	64 20%	58 18%

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.
Measure Participants	319	320	322
Count of Participants [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.
Measure Participants	319	320	322
Count of Participants [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.
Measure Participants	319	320	322
Count of Participants [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.
Measure Participants	319	320	321
Mean (Standard Deviation) [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.
Measure Participants	319	320	321
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.
Measure Participants	319	320	321
Week 2:Normal number of stools	16 5%	32 10%	26 8.1%
Week 2:1-2 stools more than normal	82 25.7%	99 30.9%	94 29.2%
Week 2: 3-4 stools more than normal	85 26.6%	88 27.5%	90 28%
Week 2: 5 or more stools more than normal	136 42.6%	101 31.6%	111 34.5%
Week 4:Normal number of stools	30 9.4%	36 11.3%	50 15.5%
Week 4:1-2 stools more than normal	85 26.6%	122 38.1%	126 39.1%
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%
Week 8:1-2 stools more than normal	93 29.2%	112 35%	110 34.2%
Week 8: 3-4 stools more than normal	76 23.8%	61 19.1%	85 26.4%
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.
Measure Participants	319	320	322
Week 2: No blood seen	83 26%	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%
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.
Measure Participants	319	320	322
Week 8: Normal or inactive disease	12 3.8%	33 10.3%	25 7.8%
Week 8:Mild disease	32 10%	51 15.9%	62 19.3%
Week 8: Moderate disease	99 31%	96 30%	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.
Measure Participants	319	320	322
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 51.3%	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%	136 42.5%	135 41.9%
Week 8: Moderate disease	153 48%	115 35.9%	106 32.9%
Week 8: Severe disease	62 19.4%	32 10%	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.
Measure Participants	319	320	322
Participants with BF	2 0.6%	19 5.9%	21 6.5%
Participants without BF	15 4.7%	31 9.7%	29 9%

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.
Measure Participants	319	320	322
Participants with BF	4 1.3%	19 5.9%	22 6.8%
Participants without BF	16 5%	34 10.6%	39 12.1%

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.
Measure Participants	319	320	322
Participants with BF	11 3.4%	30 9.4%	35 10.9%
Participants without BF	33 10.3%	54 16.9%	52 16.1%

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.
Measure Participants	319	320	322
Participants with BF	44 13.8%	74 23.1%	95 29.5%
Participants without BF	56 17.6%	90 28.1%	104 32.3%

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.
Measure Participants	319	320	322
Count of Participants [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.
Measure Participants	319	320	322
Count of Participants [Participants]	10 3.1%	35 10.9%	29 9%

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.
Measure Participants	316	315	320
Change at Week 2	-0.01	-0.75	-0.92
Change at Week 4	-0.18	-1.08	-1.94
Change at Week 8	0.00	-1.30	-1.43

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.
Measure Participants	185	185	199
Week 2	36 11.3%	54 16.9%	58 18%
Week 4	41 12.9%	70 21.9%	75 23.3%
Week 8	39 12.2%	63 19.7%	77 23.9%

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.
Measure Participants	294	302	306
Change at Week 2	0.00	-4.67	-24.06
Change at Week 4	0.00	-29.26	-69.51
Change at Week 8	-4.71	-43.41	-101.46

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.
Measure Participants	280	291	294
Week 2	16 5%	17 5.3%	15 4.7%
Week 4	16 5%	37 11.6%	33 10.2%
Week 8	26 8.2%	50 15.6%	43 13.4%

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.
Measure Participants	289	296	300
Change at Week 2	0.00	-29.00	-127.00
Change at Week 4	-2.00	-223.00	-485.50
Change at Week 8	-59.00	-431.50	-715.50

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.
Measure Participants	250	264	274
Week 2	20 6.3%	37 11.6%	37 11.5%
Week 4	25 7.8%	45 14.1%	47 14.6%
Week 8	51 16%	64 20%	70 21.7%

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.
Measure Participants	319	320	322
Count of Participants [Participants]	118 37%	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.
Measure Participants	319	320	322
Bowel: Change at Week 8	5.9 (10.34)	12.5 (11.27)	12.7 (11.11)
Emotional: Change at Week 8	5.3 (12.33)	10.1 (12.39)	11.2 (12.33)
Systemic: Change at Week 8	2.3 (5.59)	5.1 (5.59)	5.2 (5.65)
Social: Change at Week 8	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.
Measure Participants	319	320	322
PCS: Change at Week 8	2.1 (6.39)	4.7 (6.49)	5.2 (6.16)
MCS: Change at Week 8	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.
Measure Participants	319	318	322
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.
Measure Participants	317	319	322
Mean (Standard Deviation) [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.
Measure Participants	317	319	322
Mean (Standard Deviation) [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.
Measure Participants	319	320	322
Mobility:Improved at Week 8	18.0 5.6%	16.3 5.1%	24.2 7.5%
Mobility:No change at Week 8	71.9 22.5%	71.8 22.4%	66.8 20.7%
Mobility:Worsened at Week 8	10.1 3.2%	11.9 3.7%	9.0 2.8%
Self-care:Improved at Week 8	5.4 1.7%	6.9 2.2%	7.5 2.3%
Self-care:No change at Week 8	89.6 28.1%	88.4 27.6%	90.4 28.1%
Self-care:Worsened at Week 8	5.0 1.6%	4.7 1.5%	2.2 0.7%
Usual activities:Improved at Week 8	34.1 10.7%	49.5 15.5%	45.0 14%
Usual activities:No Change at Week 8	51.1 16%	40.4 12.6%	44.1 13.7%
Usual activities:Worsened at Week 8	14.8 4.6%	10.0 3.1%	10.9 3.4%
Pain/discomfort: Improved at Week 8	34.4 10.8%	44.2 13.8%	43.5 13.5%
Pain/discomfort: No Change at Week 8	49.8 15.6%	48.3 15.1%	48.1 14.9%
Pain/discomfort: Worsened at Week 8	15.8 5%	7.5 2.3%	8.4 2.6%
Anxiety/depression: Improved at Week 8	26.8 8.4%	33.5 10.5%	37.6 11.7%
Anxiety/depression: No Change at Week 8	55.5 17.4%	54.2 16.9%	51.6 16%
Anxiety/depression: Worsened at Week 8	17.7 5.5%	12.2 3.8%	10.9 3.4%

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.
Measure Participants	175	172	176
Mean (Standard Deviation) [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.
Measure Participants	175	172	176
Mean (Standard Deviation) [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.
Measure Participants	175	172	176
Week 4:Normal number of stools	56 17.6%	61 19.1%	58 18%
Week 4:1-2 stools more than normal	91 28.5%	76 23.8%	86 26.7%
Week 4: 3-4 stools more than normal	21 6.6%	26 8.1%	29 9%
Week 4: 5 or more stools more than normal	7 2.2%	9 2.8%	3 0.9%
Week 8:Normal number of stools	70 21.9%	62 19.4%	61 18.9%
Week 8:1-2 stools more than normal	69 21.6%	75 23.4%	84 26.1%
Week 8: 3-4 stools more than normal	22 6.9%	25 7.8%	26 8.1%
Week 8: 5 or more stools more than normal	14 4.4%	10 3.1%	5 1.6%
Week 12:Normal number of stools	62 19.4%	55 17.2%	64 19.9%
Week 12:1-2 stools more than normal	72 22.6%	75 23.4%	85 26.4%
Week 12: 3-4 stools more than normal	20 6.3%	28 8.8%	21 6.5%
Week 12: 5 or more stools more than normal	21 6.6%	14 4.4%	6 1.9%
Week 16:Normal number of stools	63 19.7%	51 15.9%	73 22.7%
Week 16:1-2 stools more than normal	66 20.7%	78 24.4%	77 23.9%
Week 16: 3-4 stools more than normal	25 7.8%	27 8.4%	15 4.7%
Week 16: 5 or more stools more than normal	21 6.6%	16 5%	11 3.4%
Week 20:Normal number of stools	59 18.5%	63 19.7%	67 20.8%
Week 20:1-2 stools more than normal	55 17.2%	65 20.3%	85 26.4%
Week 20: 3-4 stools more than normal	34 10.7%	26 8.1%	15 4.7%
Week 20: 5 or more stools more than normal	27 8.5%	18 5.6%	9 2.8%
Week 24:Normal number of stools	50 15.7%	64 20%	72 22.4%
Week 24:1-2 stools more than normal	63 19.7%	61 19.1%	73 22.7%
Week 24: 3-4 stools more than normal	31 9.7%	31 9.7%	20 6.2%
Week 24: 5 or more stools more than normal	31 9.7%	16 5%	11 3.4%
Week 28:Normal number of stools	52 16.3%	64 20%	67 20.8%
Week 28:1-2 stools more than normal	53 16.6%	64 20%	76 23.6%
Week 28: 3-4 stools more than normal	34 10.7%	24 7.5%	22 6.8%
Week 28: 5 or more stools more than normal	36 11.3%	20 6.3%	11 3.4%
Week 32:Normal number of stools	51 16%	59 18.4%	72 22.4%
Week 32:1-2 stools more than normal	55 17.2%	66 20.6%	73 22.7%
Week 32: 3-4 stools more than normal	35 11%	25 7.8%	18 5.6%
Week 32: 5 or more stools more than normal	34 10.7%	22 6.9%	13 4%
Week 36:Normal number of stools	49 15.4%	59 18.4%	77 23.9%
Week 36:1-2 stools more than normal	52 16.3%	60 18.8%	66 20.5%
Week 36: 3-4 stools more than normal	36 11.3%	29 9.1%	18 5.6%
Week 36: 5 or more stools more than normal	38 11.9%	24 7.5%	15 4.7%
Week 40:Normal number of stools	49 15.4%	55 17.2%	81 25.2%
Week 40:1-2 stools more than normal	50 15.7%	65 20.3%	58 18%
Week 40: 3-4 stools more than normal	36 11.3%	26 8.1%	21 6.5%
Week 40: 5 or more stools more than normal	40 12.5%	26 8.1%	16 5%
Week 44:Normal number of stools	46 14.4%	62 19.4%	71 22%
Week 44:1-2 stools more than normal	53 16.6%	57 17.8%	72 22.4%
Week 44: 3-4 stools more than normal	35 11%	28 8.8%	16 5%
Week 44: 5 or more stools more than normal	41 12.9%	25 7.8%	17 5.3%

46. Secondary Outcome

Title	Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44
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 <half time, 2 = obvious blood with stool most of time, and 3 = blood alone passed. Higher scores = worsening of disease. Participants who had prohibited change in concomitant 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 before Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing Mayo subscores at timepoint had 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.
Measure Participants	175	172	176
Week 4:No blood seen	149 46.7%	148 46.3%	143 44.4%
Week 4:Streaks of blood with stool < half time	20 6.3%	23 7.2%	29 9%
Week 4: Obvious blood with stool most of the time	4 1.3%	1 0.3%	24 7.5%
Week 4: Blood alone passed	2 0.6%	0 0%	0 0%
Week 8:No blood seen	139 43.6%	151 47.2%	141 43.8%
Week 8:Streaks of blood with stool < half time	27 8.5%	17 5.3%	31 9.6%
Week 8: Obvious blood with stool most of time	6 1.9%	3 0.9%	4 1.2%
Week 8:Blood alone passed	3 0.9%	1 0.3%	0 0%
Week 12:No blood seen	141 44.2%	144 45%	149 46.3%
Week 12:Streaks of blood with stool <half time	21 6.6%	19 5.9%	18 5.6%
Week 12: Obvious blood with stool most of the time	10 3.1%	8 2.5%	6 1.9%
Week 12: Blood alone passed	3 0.9%	1 0.3%	3 0.9%
Week 16:No blood seen	134 42%	145 45.3%	150 46.6%
Week 16:Streaks of blood with stool < half time	24 7.5%	17 5.3%	17 5.3%
Week 16: Obvious blood with stool most of the time	13 4.1%	8 2.5%	8 2.5%
Week 16: Blood alone passed	4 1.3%	2 0.6%	1 0.3%
Week 20:No blood seen	120 37.6%	141 44.1%	144 44.7%
Week 20:Streaks of blood with stool <half time	31 9.7%	17 5.3%	20 6.2%
Week 20: Obvious blood with stool most of the time	19 6%	12 3.8%	11 3.4%
Week 20: Blood alone passed	5 1.6%	2 0.6%	1 0.3%
Week 24:No blood seen	114 35.7%	139 43.4%	144 44.7%
Week 24:Streaks of blood with stool <half time	32 10%	18 5.6%	19 5.9%
Week 24: Obvious blood with stool most of the time	23 7.2%	12 3.8%	11 3.4%
Week 24: Blood alone passed	6 1.9%	3 0.9%	2 0.6%
Week 28:No blood seen	114 35.7%	141 44.1%	147 45.7%
Week 28:Streaks of blood with stool <half time	26 8.2%	18 5.6%	12 3.7%
Week 28: Obvious blood with stool most of the time	28 8.8%	10 3.1%	14 4.3%
Week 28: Blood alone passed	7 2.2%	3 0.9%	3 0.9%
Week 32:No blood seen	109 34.2%	138 43.1%	147 45.7%
Week 32:Streaks of blood with stool <half time	32 10%	16 5%	13 4%
Week 32: Obvious blood with stool most of the time	25 7.8%	14 4.4%	14 4.3%
Week 32: Blood alone passed	9 2.8%	4 1.3%	2 0.6%
Week 36:No blood seen	108 33.9%	136 42.5%	150 46.6%
Week 36:Streaks of blood with stool <half time	30 9.4%	18 5.6%	9 2.8%
Week 36: Obvious blood with stool most of the time	28 8.8%	15 4.7%	15 4.7%
Week 36: Blood alone passed	9 2.8%	3 0.9%	2 0.6%
Week 40:No blood seen	105 32.9%	132 41.3%	147 45.7%
Week 40:Streaks of blood with stool <half time	33 10.3%	22 6.9%	10 3.1%
Week 40: Obvious blood with stool most of the time	28 8.8%	13 4.1%	17 5.3%
Week 40: Blood alone passed	9 2.8%	5 1.6%	2 0.6%
Week 44:No blood seen	101 31.7%	137 42.8%	139 43.2%
Week 44::Streaks of blood with stool <half time	35 11%	15 4.7%	16 5%
Week 44: Obvious blood with stool most of the time	30 9.4%	15 4.7%	19 5.9%
Week 44: Blood alone passed	9 2.8%	5 1.6%	2 0.6%

47. Secondary Outcome

Title	Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44
Description	The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 =normal/ 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 = worsening of disease. Participants who had prohibited change in concomitant 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 had Week 0 value of induction study carried forward from time of event onward and who had missing endoscopy subscores at timepoint had last available value for that subscore 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 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.
Measure Participants	175	172	176
Week 44: Normal or inactive disease	33 10.3%	43 13.4%	52 16.1%
Week 44:Mild disease	21 6.6%	37 11.6%	42 13%
Week 44: Moderate disease	40 12.5%	42 13.1%	50 15.5%
Week 44: Severe disease	81 25.4%	50 15.6%	32 9.9%

48. Secondary Outcome

Title	Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44
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, 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 and 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	Induction Study (IS): Placebo Intravenous (IV)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (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 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.
Measure Participants	175	172	176
Week 4:Normal	62 19.4%	61 19.1%	59 18.3%
Week 4:Mild disease	100 31.3%	99 30.9%	105 32.6%
Week 4: Moderate disease	12 3.8%	12 3.8%	11 3.4%
Week 4: Severe disease	1 0.3%	0 0%	1 0.3%
Week 8:Normal	65 20.4%	70 21.9%	76 23.6%
Week 8:Mild disease	90 28.2%	89 27.8%	88 27.3%
Week 8: Moderate disease	17 5.3%	13 4.1%	11 3.4%
Week 8:Severe disease	3 0.9%	0 0%	1 0.3%
Week 12:Normal	66 20.7%	68 21.3%	73 22.7%
Week 12:Mild disease	79 24.8%	81 25.3%	88 27.3%
Week 12: Moderate disease	26 8.2%	16 5%	14 4.3%
Week 12: Severe disease	4 1.3%	7 2.2%	1 0.3%
Week 16:Normal	67 21%	82 25.6%	83 25.8%
Week 16:Mild disease	68 21.3%	69 21.6%	78 24.2%
Week 16: Moderate disease	32 10%	14 4.4%	13 4%
Week 16: Severe disease	8 2.5%	7 2.2%	2 0.6%
Week 20:Normal	65 20.4%	85 26.6%	84 26.1%
Week 20:Mild disease	57 17.9%	63 19.7%	73 22.7%
Week 20: Moderate disease	41 12.9%	16 5%	16 5%
Week 20: Severe disease	12 3.8%	8 2.5%	3 0.9%
Week 24:Normal	54 16.9%	84 26.3%	91 28.3%
Week 24:Mild disease	61 19.1%	65 20.3%	68 21.1%
Week 24: Moderate disease	44 13.8%	14 4.4%	15 4.7%
Week 24: Severe disease	16 5%	9 2.8%	2 0.6%
Week 28:Normal	58 18.2%	86 26.9%	89 27.6%
Week 28:Mild disease	52 16.3%	63 19.7%	65 20.2%
Week 28: Moderate disease	47 14.7%	14 4.4%	20 6.2%
Week 28: Severe disease	18 5.6%	9 2.8%	2 0.6%
Week 32:Normal	55 17.2%	84 26.3%	92 28.6%
Week 32:Mild disease	52 16.3%	56 17.5%	62 19.3%
Week 32: Moderate disease	46 14.4%	23 7.2%	19 5.9%
Week 32: Severe disease	22 6.9%	9 2.8%	3 0.9%
Week 36: Normal	59 18.5%	78 24.4%	93 28.9%
Week 36:Mild disease	45 14.1%	60 18.8%	60 18.6%
Week 36: Moderate disease	47 14.7%	24 7.5%	19 5.9%
Week 36: Severe disease	24 7.5%	10 3.1%	4 1.2%
Week 40:Normal	57 17.9%	83 25.9%	91 28.3%
Week 40:Mild disease	48 15%	50 15.6%	60 18.6%
Week 40: Moderate disease	44 13.8%	24 7.5%	21 6.5%
Week 40: Severe disease	26 8.2%	15 4.7%	4 1.2%
Week 44:Normal	47 14.7%	78 24.4%	85 26.4%
Week 44:Mild disease	44 13.8%	54 16.9%	62 19.3%
Week 44:Moderate disease	57 17.9%	24 7.5%	25 7.8%
Week 44: Severe disease	27 8.5%	16 5%	4 1.2%

49. Secondary Outcome

Title	Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44
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, 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. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.
Time Frame	Baseline through 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.
Measure Participants	175	172	176
Change at Week 4	-0.2 (1.24)	-0.3 (1.23)	-0.1 (1.26)
Change at Week 8	-0.1 (1.59)	-0.3 (1.15)	-0.2 (1.44)
Change at Week 12	0.1 (1.82)	0.0 (1.66)	-0.2 (1.63)
Change at Week 16	0.3 (2.07)	-0.1 (1.76)	-0.3 (1.76)
Change at Week 20	0.6 (2.36)	-0.1 (1.91)	-0.2 (1.92)
Change at Week 24	0.9 (2.34)	0.0 (2.02)	-0.3 (1.88)
Change at Week 28	1.0 (2.53)	-0.1 (1.95)	-0.2 (1.94)
Change at Week 32	1.1 (2.60)	0.1 (2.12)	-0.2 (1.96)
Change at Week 36	1.2 (2.62)	0.2 (2.13)	-0.2 (2.08)
Change at Week 40	1.3 (2.64)	0.3 (2.27)	-0.2 (1.97)
Change at Week 44	1.5 (2.63)	0.3 (2.29)	0.0 (2.09)

50. Secondary Outcome

Title	Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44
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, 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. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.
Time Frame	Baseline through 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.
Measure Participants	175	172	176
Change at Week 4	-4.2 (1.70)	-4.5 (1.76)	-4.4 (1.72)
Change at Week 8	-4.1 (1.80)	-4.5 (1.68)	-4.5 (1.85)
Change at Week 12	-3.9 (2.07)	-4.2 (2.02)	-4.5 (2.02)
Change at Week 16	-3.7 (2.17)	-4.3 (2.07)	-4.6 (2.08)
Change at Week 20	-3.4 (2.26)	-4.3 (2.13)	-4.5 (2.13)
Change at Week 24	-3.1 (2.36)	-4.2 (2.26)	-4.5 (2.18)
Change at Week 28	-3.0 (2.49)	-4.3 (2.26)	-4.4 (2.27)
Change at Week 32	-2.9 (2.51)	-4.1 (2.40)	-4.5 (2.30)
Change at Week 36	-2.8 (2.43)	-4.0 (2.43)	-4.5 (2.40)
Change at Week 40	-2.7 (2.51)	-3.9 (2.46)	-4.5 (2.39)
Change at Week 44	-2.5 (2.52)	-3.9 (2.49)	-4.3 (2.48)

51. Secondary Outcome

Title	Maintenance 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 44
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 44 were reported. 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 and who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in 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.
Measure Participants	175	172	176
Count of Participants [Participants]	49 15.4%	70 21.9%	84 26.1%

52. Secondary Outcome

Title	Maintenance 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 44
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 44 were reported. 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 or who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in 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.
Measure Participants	175	172	176
Count of Participants [Participants]	30 9.4%	42 13.1%	48 14.9%

53. Secondary Outcome

Title	Maintenance Study: Number of Participants in Symptomatic Remission at Week 44
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, 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 were considered not to be in symptomatic remission from the time of the event onward. Participants who had both stool frequency and rectal bleeding subscores missing at Week 44 were considered not to be in symptomatic remission for that visit. 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.
Measure Participants	175	172	176
Count of Participants [Participants]	79 24.8%	107 33.4%	119 37%

54. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure 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=worsening of disease. 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/ were intolerant of medication. 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 or who had all 4 Mayo subscores missing at Week 44 considered not in clinical remission. 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. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.

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.
Measure Participants	175	172	176
Participants with BF	15 4.7%	16 5%	36 11.2%
Participants without BF	27 8.5%	50 15.6%	41 12.7%

55. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition)
Description	US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore: 0 (no blood seen), Mayo endoscopy subscore: 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). BF: participants received 1/ more TNF antagonists/ vedolizumab for treatment of UC, not responded initially/ responded initially but lost response/ were intolerant of medicines. Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect /due to AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components (absolute stool number, rectal bleeding and endoscopy) at Week 44 were not in clinical remission. Endoscopy subscore assessed during central review used video of endoscopy.
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. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.

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.
Measure Participants	175	172	176
Participants with BF	15 4.7%	17 5.3%	34 10.6%
Participants without BF	28 8.8%	51 15.9%	41 12.7%

56. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status
Description	Clinical response: decrease from IS baseline in Mayo score by >=30% and >=3 points, with either decrease from baseline in RB subscore >=1/ RB subscore of 0/ 1. Mayo score have 4 subscores (SF, RB, endoscopy findings, PGA), rated 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: 1/ more TNF antagonists/ vedolizumab for treating UC, no respond initially/responded initially but lost response/ medication intolerant. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsen UC before Week 44, had all 4 Mayo subscores miss at Week44/ lost clinical response at any time before Week44 were not in clinical response upto Week44. Endoscopy subscore assessed during central review used endoscopy video.
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. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

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.
Measure Participants	175	172	176
Participants with BF	34 10.7%	39 12.2%	59 18.3%
Participants without BF	44 13.8%	78 24.4%	66 20.5%

57. Secondary Outcome

Title	Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status
Description	Number of participants with endoscopic healing at week 44 by BF status were reported. Endoscopic healing is improvement in endoscopic appearance of 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 or more tumor necrosis factor (TNF) antagonists or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response, or were intolerant of medication. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy, or used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to 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. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

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.
Measure Participants	175	172	176
Participants with BF	20 6.3%	18 5.6%	41 12.7%
Participants without BF	30 9.4%	57 17.8%	49 15.2%

58. Secondary Outcome

Title	Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline
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, 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 a 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, with participants who had achieved endoscopic healing 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.
Measure Participants	71	68	57
Count of Participants [Participants]	25 7.8%	41 12.8%	37 11.5%

59. Secondary Outcome

Title	Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44
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, 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 a 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.
Measure Participants	175	172	176
Count of Participants [Participants]	32 10%	41 12.8%	51 15.8%

60. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (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 0(normal) to 3(severe). Total score=sum of 4 subscores, range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. 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 considered not to achieved OM of clinical remission and not receiving concomitant corticosteroids (corticosteroid-free clinical remission). Participants with all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Participants missing value in corticosteroid use had their 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 with, participants who were receiving concomitant corticosteroids 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.
Measure Participants	91	82	92
Count of Participants [Participants]	17 5.3%	25 7.8%	36 11.2%

61. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per US Definition)
Description	US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and Mayo endoscopy subscore of 0(normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number is average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated as 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 who were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and endoscopy subscore) at Week 44 were considered not in clinical remission. Participants with missing value in corticosteroid use 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, with participants who were receiving concomitant corticosteroids 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.
Measure Participants	91	82	92
Count of Participants [Participants]	18 5.6%	27 8.4%	34 10.6%

62. Secondary Outcome

Title	MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline
Description	The change from maintenance baseline in average daily prednisone-equivalent (P.Eq) corticosteroid dose through Week 44 among the participants receiving concomitant corticosteroids other than budesonide and beclomethasone dipropionate at maintenance baseline was reported. 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 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing value in corticosteroid use at a timepoint had their last available value carried forward to that timepoint.
Time Frame	Baseline Through 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 receiving concomitant corticosteroids 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.
Measure Participants	75	69	82
Change at Week 4	-7.4 (5.73)	-7.8 (5.48)	-7.2 (5.42)
Change at Week 8	-10.8 (6.77)	-11.7 (8.17)	-12.1 (6.81)
Change at Week 12	-10.1 (8.71)	-11.6 (9.16)	-12.6 (7.00)
Change at Week 16	-10.1 (7.73)	-12.1 (8.37)	-12.8 (6.98)
Change at Week 20	-9.5 (7.85)	-12.0 (8.44)	-12.6 (7.27)
Change at Week 24	-8.9 (7.96)	-11.9 (8.62)	-12.5 (7.88)
Change at Week 28	-7.8 (8.72)	-11.5 (9.23)	-12.4 (7.56)
Change at Week 32	-7.7 (8.18)	-11.4 (8.98)	-12.1 (8.21)
Change at Week 36	-7.6 (8.28)	-11.3 (8.80)	-11.7 (8.34)
Change at Week 40	-7.2 (8.04)	-11.5 (8.62)	-11.5 (8.37)
Change at Week 44	-6.8 (7.98)	-11.0 (8.87)	-11.5 (8.37)

63. Secondary Outcome

Title	Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline
Description	Number of participants not receiving concomitant corticosteroids at Week 44 among participants who received concomitant corticosteroids at maintenance Baseline were reported. 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 considered to be receiving concomitant corticosteroids at Week 44. Participants who had a missing value in corticosteroid use at Week 44 had their last value carried forward.
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 with, participants who were receiving concomitant corticosteroids 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.
Measure Participants	91	82	92
Count of Participants [Participants]	43 13.5%	56 17.5%	73 22.7%

64. Secondary Outcome

Title	Maintenance Study: Number of Participants Who Maintained 20-point Improvement From Induction Baseline in IBDQ up to Week 44 Among Participants With a >20-point Improvement in IBDQ at Maintenance Baseline
Description	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 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 missing IBDQ score were considered not to have maintained improvement in IBDQ.
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 with >20-point Improvement in IBDQ at the 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.
Measure Participants	129	144	143
Count of Participants [Participants]	64 20.1%	95 29.7%	102 31.7%

65. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44
Description	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 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 prohibited change in concomitant UC medication or ostomy or colectomy prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing IBDQ score at a timepoint had their last value carried forward.
Time Frame	Baseline, Week 20, and 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. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
Change at Week 20	-7.0 (31.37)	0.8 (29.05)	5.5 (27.40)
Change at Week 44	-15.1 (35.43)	-3.0 (32.89)	3.9 (31.54)

66. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44
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); 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 44 had their Week 0 value of induction study carried forward from time of event onward and participants who had missing IBDQ dimension score at a timepoint had their last available value carried forward.
Time Frame	Baseline, Week 20, and 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 the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM for specified categories at specified timepoint.

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.
Measure Participants	175	172	176
Bowel:Change at Week 20	-3.2 (10.88)	-0.5 (9.16)	1.3 (9.56)
Bowel:Change at Week 44	-5.7 (12.34)	-1.6 (10.99)	0.8 (10.49)
Emotional: Change at Week 20	-1.9 (12.16)	0.9 (11.12)	2.2 (10.56)
Emotional: Change at Week 44	-4.7 (13.84)	-0.5 (12.17)	1.4 (12.22)
Systemic: Change at Week 20	-1.1 (5.54)	0.0 (5.31)	0.7 (5.24)
Systemic: Change at Week 44	-2.2 (5.52)	-0.5 (5.97)	0.5 (5.83)
Social: Change at Week 20	-0.7 (5.93)	0.3 (6.59)	1.4 (5.44)
Social: Change at Week 44	-2.5 (6.72)	-0.5 (7.10)	1.1 (6.29)

67. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44
Description	SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, PCS (calculated from subscales physical functioning, role-physical, bodily pain, and general health) and 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 with prohibited change in concomitant 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 before Week 44 had Week 0 value of IS carried forward from time of event onward and participants with missing component summary score at timepoint had last available value carried forward.
Time Frame	Baseline, Weeks 20, and 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. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
PCS: Change at Week 20	-1.2 (6.20)	-0.2 (6.15)	0.8 (5.55)
PCS: Change at Week 44	-1.7 (6.45)	-0.4 (7.14)	1.3 (5.68)
MCS: Change at Week 20	-1.1 (8.90)	1.0 (8.91)	0.4 (9.10)
MCS: Change at Week 44	-2.4 (9.89)	0.3 (8.41)	0.3 (9.51)

68. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44
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/ ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had Week 0 value of induction study carried forward from time of event onward and participants with missing individual scale score at timepoint had last available value carried forward.
Time Frame	Baseline, Weeks 20, and 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. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
Physical functioning: Change at Week 20	-0.61 (6.140)	-0.01 (5.506)	0.51 (4.809)
Physical functioning: Change at Week 44	-1.40 (5.932)	-0.44 (5.624)	0.66 (4.819)
Role-physical: Change at Week 20	-0.61 (8.630)	0.17 (7.996)	0.23 (8.144)
Role-physical: Change at Week 44	-2.27 (9.400)	-0.84 (8.293)	1.08 (8.096)
Bodily pain:Change at Week 20	-2.80 (9.081)	-0.30 (8.556)	1.06 (8.971)
Bodily pain:Change at Week 44	-2.33 (9.245)	0.23 (9.340)	0.94 (8.350)
General health:Change at Week 20	-0.95 (7.468)	0.67 (7.802)	1.14 (7.133)
General health:Change at Week 44	-1.62 (7.449)	0.24 (8.722)	1.92 (7.955)
Vitality:Change at Week 20	-1.71 (8.876)	0.74 (8.917)	0.39 (9.209)
Vitality:Change at Week 44	-3.18 (10.389)	0.11 (9.152)	0.53 (9.743)
Social functioning: Change at Week 20	-0.87 (9.245)	0.47 (8.979)	0.72 (9.907)
Social functioning: Change at Week 44	-1.83 (10.186)	0.06 (9.515)	1.12 (9.678)
Role-emotional: Change at Week 20	-0.93 (9.586)	0.47 (9.338)	0.14 (8.637)
Role-emotional: Change at Week 44	-2.21 (10.187)	0.04 (9.324)	0.10 (8.199)
Mental health:Change at Week 20	-1.07 (9.085)	1.08 (8.631)	0.61 (8.467)
Mental health:Change at Week 44	-2.15 (9.992)	0.06 (8.042)	0.53 (8.915)

69. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44
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 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 and participants who had a missing individual scale score at a timepoint had their last available value carried forward.
Time Frame	Baseline, Weeks 20, and 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. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
Change at Week 20	-0.036 (0.1535)	-0.002 (0.1694)	0.016 (0.1471)
Change at Week 44	-0.048 (0.1587)	0.008 (0.1656)	0.025 (0.1674)

70. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44
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 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 and participants who had a missing VAS score at a timepoint had their last available value carried forward.
Time Frame	Baseline, Weeks 20 and 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. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
Change at Week 20	-4.0 (16.70)	-0.3 (17.29)	2.6 (17.80)
Change at Week 44	-7.7 (18.75)	-2.2 (19.87)	2.4 (17.28)

71. Secondary Outcome

Title	Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44
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/ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing individual scale score at timepoint had their last available value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.
Time Frame	Baseline, Weeks 20, and 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. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
Change at Week (W) 20: Mobility:Improved	12.7 4%	10.5 3.3%	13.7 4.3%
Change at W 20:Mobility:No change	75.7 23.7%	79.1 24.7%	78.9 24.5%
Change at W 20:Mobility:Worsened	11.6 3.6%	10.5 3.3%	7.4 2.3%
Change at W 44:Mobility:Improved	9.8 3.1%	11.6 3.6%	12.0 3.7%
Change at W 44:Mobility:No change	75.1 23.5%	76.2 23.8%	79.4 24.7%
Change at W 44:Mobility:Worsened	15.0 4.7%	12.2 3.8%	8.6 2.7%
Change at W 20:Self-care:Improved	1.7 0.5%	1.7 0.5%	4.0 1.2%
Change at W 20:Self-care:No change	91.9 28.8%	93.6 29.3%	93.7 29.1%
Change at W 20:Self-care:Worsened	6.4 2%	4.7 1.5%	2.3 0.7%
Change at W 44:Self-care:Improved	1.7 0.5%	2.3 0.7%	4.0 1.2%
Change at W 44:Self-care:No change	95.4 29.9%	93.0 29.1%	93.1 28.9%
Change at W 44:Self-care:Worsened	2.9 0.9%	4.7 1.5%	2.9 0.9%
Change at W 20:Usual activities:Improved	12.7 4%	17.4 5.4%	22.3 6.9%
Change at W 20:Usual activities:No Change	64.2 20.1%	66.9 20.9%	64.0 19.9%
Change at W 20:Usual activities:Worsened	23.1 7.2%	15.7 4.9%	13.7 4.3%
Change at W 44: Usual activities:Improved	14.5 4.5%	24.4 7.6%	25.1 7.8%
Change at W 44:Usual activities:No Change	52.6 16.5%	55.2 17.3%	62.9 19.5%
Change at W 44:Usual activities:Worsened	32.9 10.3%	20.3 6.3%	12.0 3.7%
Change at W 20:Pain/discomfort: Improved	16.8 5.3%	22.1 6.9%	23.4 7.3%
Change at W 20:Pain/discomfort: No Change	54.9 17.2%	58.7 18.3%	58.9 18.3%
Change at W 20:Pain/discomfort: Worsened	28.3 8.9%	19.2 6%	17.7 5.5%
Change at W 44:Pain/discomfort: Improved	17.9 5.6%	25.0 7.8%	30.3 9.4%
Change at W 44:Pain/discomfort: No Change	46.2 14.5%	55.8 17.4%	50.9 15.8%
Change at W 44:Pain/discomfort: Worsened	35.8 11.2%	19.2 6%	18.9 5.9%
Change at W 20:Anxiety/depression: Improved	16.2 5.1%	20.3 6.3%	24.6 7.6%
Change at W 20:Anxiety/depression: No Change	62.4 19.6%	61.6 19.3%	58.3 18.1%
Change at W 20:Anxiety/depression: Worsened	21.4 6.7%	18.0 5.6%	17.1 5.3%
Change at W 44:Anxiety/depression: Improved	17.9 5.6%	20.3 6.3%	26.9 8.4%
Change at W 44:Anxiety/depression: No Change	56.1 17.6%	58.7 18.3%	58.9 18.3%
Change at W 44:Anxiety/depression: Worsened	26.0 8.2%	20.9 6.5%	14.3 4.4%

72. Secondary Outcome

Title	Maintenance Study: Number of Participants With Mucosal Healing at Week 44
Description	Mucosal healing included EH and HH. EH: endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). HH: neutrophil infiltration in <5% of crypts, no crypt destruction, no erosions/ ulcerations/ granulation tissue. Participants with prohibited change in concomitant 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/ missing endoscopy score/ missing any component of histologic healing (i.e. assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 44 and had unevaluable biopsy (biopsy collected but could not assessed due to sample preparation/ technical errors) at Week 44, but who did not achieve endoscopic healing, considered not to have mucosal healing. Endoscopy subscore assessed during central review used endoscopy video.
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, with participants whose mucosal healing status was determined at Week 44 with evaluable biopsy.

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.
Measure Participants	170	170	172
Count of Participants [Participants]	41 12.9%	66 20.6%	79 24.5%

73. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44
Description	Change from Maintenance baseline in CRP concentration at Weeks 8, 24, and 44 were reported. 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. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline, Weeks 8, 24, and 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. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
Change at Week 8	0.05	-0.03	-0.04
Change at Week 24	0.68	0.13	-0.03
Change at Week 44	1.07	0.38	-0.07

74. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44
Description	Change from Maintenance baseline in fecal lactoferrin concentration at Weeks 8, 24, and 44 were reported. 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. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline, Weeks 8, 24, and 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. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
Change at Week 8	0.0	0.0	-1.4
Change at Week 24	2.2	-0.8	-2.3
Change at Week 44	0.8	-1.9	-9.1

75. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44
Description	Change from Maintenance baseline in fecal calprotectin concentration at Weeks 8, 24, and 44 were reported. 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. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline, Weeks 8, 24, and 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. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

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.
Measure Participants	175	172	176
Change at Week 8	0.0	-18.5	-31.0
Change at Week 24	125.0	-31.5	-46.0
Change at Week 44	229.5	-37.5	-85.0

Adverse Events

Time Frame	20 weeks after last administration of study agent (up to 3 years)
Adverse Event Reporting Description	The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received. Safety analyses data reported through final safety visit (20 weeks after last administration of study agent), a participant with an adverse event was counted in a group based on the study agent the participant was receiving at the time of onset of the event and therefore may be counted in more than 1 column in a table.
Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)		IS: Ustekinumab 130 Milligram (mg) IV		IS: Ustekinumab Approximately 6 mg/kg IV		Placebo Non-responders at Week 8 Induction		Ustekinumab Non-responders at Week 8 Induction		Maintenance Study (MS): Placebo Subcutaneous (SC)		MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)		MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)		MS: Placebo IV (IS - Responders) to Placebo SC		MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC 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. Included data up to Week 8 for participants who received ustekinumab at Week 8.		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. Included data up to Week 8 for participants who received ustekinumab at Week 8.		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. Included data up to Week 8 for participants who received ustekinumab at Week 8.		Participants who did not achieve clinical response to placebo IV at Week 8 and received a single IV infusion of ustekinumab approximating 6 mg/kg at Week 8. Included data from Week 8 onward through the final safety visit.		Participants who did not achieve clinical response to ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 and received a single dose of ustekinumab 90 mg SC along with matching placebo IV (to maintain the blind). Participants with clinical response at Week 16 (that is, delayed responders) were eligible to enter Maintenance study, but were not be randomized. Included data from Week 8 onward through the final safety visit.		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.		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) received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).
All Cause Mortality
	Induction Study (IS): Placebo Intravenous (IV)		IS: Ustekinumab 130 Milligram (mg) IV		IS: Ustekinumab Approximately 6 mg/kg IV		Placebo Non-responders at Week 8 Induction		Ustekinumab Non-responders at Week 8 Induction		Maintenance Study (MS): Placebo Subcutaneous (SC)		MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)		MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)		MS: Placebo IV (IS - Responders) to Placebo SC		MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC q8w
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/319 (0%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		1/157 (0.6%)
Serious Adverse Events
	Induction Study (IS): Placebo Intravenous (IV)		IS: Ustekinumab 130 Milligram (mg) IV		IS: Ustekinumab Approximately 6 mg/kg IV		Placebo Non-responders at Week 8 Induction		Ustekinumab Non-responders at Week 8 Induction		Maintenance Study (MS): Placebo Subcutaneous (SC)		MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)		MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)		MS: Placebo IV (IS - Responders) to Placebo SC		MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC q8w
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/319 (6.9%)		12/321 (3.7%)		11/320 (3.4%)		7/184 (3.8%)		12/233 (5.2%)		17/175 (9.7%)		13/172 (7.6%)		15/176 (8.5%)		8/103 (7.8%)		11/157 (7%)
Blood and lymphatic system disorders
Anaemia	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		2/172 (1.2%)		0/176 (0%)		1/103 (1%)		0/157 (0%)
Autoimmune Haemolytic Anaemia	0/319 (0%)		1/321 (0.3%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Cardiac disorders
Atrial Fibrillation	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		1/103 (1%)		0/157 (0%)
Cardiac Arrest	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Pericarditis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Ear and labyrinth disorders
Deafness Neurosensory	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Deafness Unilateral	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Gastrointestinal disorders
Abdominal Pain	0/319 (0%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Abdominal Pain Upper	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Anal Fissure	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Anorectal Disorder	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Colitis Ulcerative	11/319 (3.4%)		4/321 (1.2%)		4/320 (1.3%)		5/184 (2.7%)		4/233 (1.7%)		8/175 (4.6%)		1/172 (0.6%)		2/176 (1.1%)		3/103 (2.9%)		7/157 (4.5%)
Colon Dysplasia	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Diarrhoea Haemorrhagic	0/319 (0%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Enteritis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		1/172 (0.6%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Enterovesical Fistula	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Large Intestine Perforation	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Large Intestine Polyp	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Lumbar Hernia	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		1/172 (0.6%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Mesenteric Fibrosis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		1/172 (0.6%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Oesophageal Varices Haemorrhage	0/319 (0%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Subileus	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		1/157 (0.6%)
Vomiting	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
General disorders
Pyrexia	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Hepatobiliary disorders
Liver Disorder	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Immune system disorders
Anaphylactic Reaction	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Infections and infestations
Anal Abscess	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Appendicitis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		1/103 (1%)		0/157 (0%)
Clostridium Difficile Infection	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Cytomegalovirus Colitis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		2/172 (1.2%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Diverticulitis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		1/172 (0.6%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Gastroenteritis	0/319 (0%)		1/321 (0.3%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		1/175 (0.6%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Gastroenteritis Salmonella	0/319 (0%)		0/321 (0%)		0/320 (0%)		1/184 (0.5%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Hepatitis C	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Influenza	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		1/172 (0.6%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Periorbital Cellulitis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Pharyngeal Abscess	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Pneumonia	0/319 (0%)		1/321 (0.3%)		0/320 (0%)		1/184 (0.5%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		1/157 (0.6%)
Pneumonia Legionella	0/319 (0%)		0/321 (0%)		0/320 (0%)		1/184 (0.5%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Pyelonephritis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		0/175 (0%)		1/172 (0.6%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Salpingitis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Subcutaneous Abscess	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Injury, poisoning and procedural complications
Ankle Fracture	0/319 (0%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Hip Fracture	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Injury	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		1/103 (1%)		0/157 (0%)
Lumbar Vertebral Fracture	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Procedural Intestinal Perforation	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Radius Fracture	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		1/157 (0.6%)
Metabolism and nutrition disorders
Diabetic Metabolic Decompensation	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		1/157 (0.6%)
Colon Cancer	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Intraductal Papilloma of Breast	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		1/172 (0.6%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Ovarian Adenoma	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Prostate Cancer	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Rectal Adenocarcinoma	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Rectal Adenoma	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Skin Papilloma	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		1/172 (0.6%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Testis Cancer	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		1/103 (1%)		0/157 (0%)
Nervous system disorders
Aphasia	0/319 (0%)		1/321 (0.3%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Cognitive Disorder	0/319 (0%)		1/321 (0.3%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Epilepsy	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Generalised Tonic-Clonic Seizure	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Ischaemic Stroke	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Migraine	0/319 (0%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Motor Dysfunction	0/319 (0%)		1/321 (0.3%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Presyncope	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		2/176 (1.1%)		0/103 (0%)		0/157 (0%)
Psychiatric disorders
Confusional State	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		1/103 (1%)		0/157 (0%)
Renal and urinary disorders
Acute Kidney Injury	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Nephrolithiasis	0/319 (0%)		1/321 (0.3%)		0/320 (0%)		1/184 (0.5%)		1/233 (0.4%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Ureterolithiasis	0/319 (0%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Urinary Incontinence	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		1/157 (0.6%)
Hyperventilation	0/319 (0%)		2/321 (0.6%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Pleurisy	1/319 (0.3%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Pulmonary Embolism	0/319 (0%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		1/172 (0.6%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Pulmonary Eosinophilia	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		1/233 (0.4%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Skin and subcutaneous tissue disorders
Dermatitis	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		1/176 (0.6%)		0/103 (0%)		0/157 (0%)
Pyoderma Gangrenosum	1/319 (0.3%)		0/321 (0%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Rash	0/319 (0%)		1/321 (0.3%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Vascular disorders
Deep Vein Thrombosis	0/319 (0%)		0/321 (0%)		2/320 (0.6%)		0/184 (0%)		1/233 (0.4%)		0/175 (0%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Haemorrhage	0/319 (0%)		0/321 (0%)		0/320 (0%)		0/184 (0%)		0/233 (0%)		1/175 (0.6%)		0/172 (0%)		0/176 (0%)		0/103 (0%)		0/157 (0%)
Other (Not Including Serious) Adverse Events
	Induction Study (IS): Placebo Intravenous (IV)		IS: Ustekinumab 130 Milligram (mg) IV		IS: Ustekinumab Approximately 6 mg/kg IV		Placebo Non-responders at Week 8 Induction		Ustekinumab Non-responders at Week 8 Induction		Maintenance Study (MS): Placebo Subcutaneous (SC)		MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)		MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)		MS: Placebo IV (IS - Responders) to Placebo SC		MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC q8w
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/319 (24.8%)		87/321 (27.1%)		90/320 (28.1%)		21/184 (11.4%)		23/233 (9.9%)		111/175 (63.4%)		86/172 (50%)		110/176 (62.5%)		67/103 (65%)		85/157 (54.1%)
Blood and lymphatic system disorders
Anaemia	11/319 (3.4%)		7/321 (2.2%)		8/320 (2.5%)		4/184 (2.2%)		1/233 (0.4%)		12/175 (6.9%)		7/172 (4.1%)		7/176 (4%)		9/103 (8.7%)		9/157 (5.7%)
Leukopenia	1/319 (0.3%)		2/321 (0.6%)		5/320 (1.6%)		0/184 (0%)		1/233 (0.4%)		4/175 (2.3%)		2/172 (1.2%)		3/176 (1.7%)		4/103 (3.9%)		6/157 (3.8%)
Gastrointestinal disorders
Abdominal Pain	9/319 (2.8%)		8/321 (2.5%)		5/320 (1.6%)		0/184 (0%)		0/233 (0%)		4/175 (2.3%)		6/172 (3.5%)		8/176 (4.5%)		3/103 (2.9%)		5/157 (3.2%)
Colitis Ulcerative	8/319 (2.5%)		5/321 (1.6%)		5/320 (1.6%)		1/184 (0.5%)		3/233 (1.3%)		47/175 (26.9%)		19/172 (11%)		16/176 (9.1%)		26/103 (25.2%)		23/157 (14.6%)
Constipation	1/319 (0.3%)		1/321 (0.3%)		1/320 (0.3%)		1/184 (0.5%)		0/233 (0%)		6/175 (3.4%)		0/172 (0%)		3/176 (1.7%)		1/103 (1%)		0/157 (0%)
Diarrhoea	1/319 (0.3%)		3/321 (0.9%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		2/175 (1.1%)		5/172 (2.9%)		7/176 (4%)		2/103 (1.9%)		6/157 (3.8%)
Haemorrhoids	0/319 (0%)		1/321 (0.3%)		1/320 (0.3%)		0/184 (0%)		1/233 (0.4%)		1/175 (0.6%)		3/172 (1.7%)		6/176 (3.4%)		0/103 (0%)		0/157 (0%)
Nausea	7/319 (2.2%)		8/321 (2.5%)		7/320 (2.2%)		3/184 (1.6%)		3/233 (1.3%)		4/175 (2.3%)		4/172 (2.3%)		6/176 (3.4%)		3/103 (2.9%)		5/157 (3.2%)
Vomiting	1/319 (0.3%)		3/321 (0.9%)		4/320 (1.3%)		0/184 (0%)		3/233 (1.3%)		6/175 (3.4%)		1/172 (0.6%)		1/176 (0.6%)		0/103 (0%)		3/157 (1.9%)
General disorders
Fatigue	5/319 (1.6%)		6/321 (1.9%)		8/320 (2.5%)		0/184 (0%)		1/233 (0.4%)		4/175 (2.3%)		4/172 (2.3%)		7/176 (4%)		3/103 (2.9%)		3/157 (1.9%)
Pyrexia	6/319 (1.9%)		4/321 (1.2%)		6/320 (1.9%)		1/184 (0.5%)		0/233 (0%)		7/175 (4%)		1/172 (0.6%)		8/176 (4.5%)		5/103 (4.9%)		5/157 (3.2%)
Infections and infestations
Bronchitis	1/319 (0.3%)		0/321 (0%)		2/320 (0.6%)		1/184 (0.5%)		0/233 (0%)		6/175 (3.4%)		5/172 (2.9%)		6/176 (3.4%)		5/103 (4.9%)		6/157 (3.8%)
Gastroenteritis	2/319 (0.6%)		2/321 (0.6%)		1/320 (0.3%)		0/184 (0%)		0/233 (0%)		5/175 (2.9%)		5/172 (2.9%)		7/176 (4%)		2/103 (1.9%)		5/157 (3.2%)
Influenza	0/319 (0%)		2/321 (0.6%)		1/320 (0.3%)		0/184 (0%)		2/233 (0.9%)		8/175 (4.6%)		5/172 (2.9%)		10/176 (5.7%)		7/103 (6.8%)		7/157 (4.5%)
Nasopharyngitis	9/319 (2.8%)		13/321 (4%)		18/320 (5.6%)		7/184 (3.8%)		1/233 (0.4%)		28/175 (16%)		31/172 (18%)		26/176 (14.8%)		13/103 (12.6%)		19/157 (12.1%)
Pharyngitis	1/319 (0.3%)		1/321 (0.3%)		0/320 (0%)		1/184 (0.5%)		0/233 (0%)		2/175 (1.1%)		3/172 (1.7%)		2/176 (1.1%)		4/103 (3.9%)		2/157 (1.3%)
Sinusitis	1/319 (0.3%)		5/321 (1.6%)		1/320 (0.3%)		0/184 (0%)		1/233 (0.4%)		2/175 (1.1%)		2/172 (1.2%)		7/176 (4%)		1/103 (1%)		3/157 (1.9%)
Upper Respiratory Tract Infection	4/319 (1.3%)		6/321 (1.9%)		4/320 (1.3%)		2/184 (1.1%)		5/233 (2.1%)		8/175 (4.6%)		5/172 (2.9%)		16/176 (9.1%)		4/103 (3.9%)		7/157 (4.5%)
Investigations
Alanine Aminotransferase Increased	2/319 (0.6%)		0/321 (0%)		6/320 (1.9%)		0/184 (0%)		0/233 (0%)		4/175 (2.3%)		5/172 (2.9%)		7/176 (4%)		3/103 (2.9%)		2/157 (1.3%)
Aspartate Aminotransferase Increased	2/319 (0.6%)		0/321 (0%)		3/320 (0.9%)		0/184 (0%)		0/233 (0%)		4/175 (2.3%)		5/172 (2.9%)		5/176 (2.8%)		4/103 (3.9%)		4/157 (2.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/319 (0.9%)		3/321 (0.9%)		6/320 (1.9%)		1/184 (0.5%)		2/233 (0.9%)		15/175 (8.6%)		15/172 (8.7%)		8/176 (4.5%)		9/103 (8.7%)		13/157 (8.3%)
Back Pain	4/319 (1.3%)		2/321 (0.6%)		4/320 (1.3%)		0/184 (0%)		1/233 (0.4%)		7/175 (4%)		1/172 (0.6%)		7/176 (4%)		4/103 (3.9%)		5/157 (3.2%)
Nervous system disorders
Headache	14/319 (4.4%)		22/321 (6.9%)		13/320 (4.1%)		2/184 (1.1%)		2/233 (0.9%)		7/175 (4%)		11/172 (6.4%)		18/176 (10.2%)		4/103 (3.9%)		9/157 (5.7%)
Psychiatric disorders
Anxiety	4/319 (1.3%)		1/321 (0.3%)		0/320 (0%)		1/184 (0.5%)		0/233 (0%)		2/175 (1.1%)		3/172 (1.7%)		2/176 (1.1%)		4/103 (3.9%)		0/157 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	3/319 (0.9%)		4/321 (1.2%)		3/320 (0.9%)		0/184 (0%)		0/233 (0%)		5/175 (2.9%)		2/172 (1.2%)		7/176 (4%)		4/103 (3.9%)		4/157 (2.5%)
Oropharyngeal Pain	1/319 (0.3%)		1/321 (0.3%)		8/320 (2.5%)		1/184 (0.5%)		0/233 (0%)		5/175 (2.9%)		4/172 (2.3%)		7/176 (4%)		1/103 (1%)		1/157 (0.6%)
Skin and subcutaneous tissue disorders
Acne	3/319 (0.9%)		1/321 (0.3%)		2/320 (0.6%)		0/184 (0%)		0/233 (0%)		0/175 (0%)		2/172 (1.2%)		3/176 (1.7%)		4/103 (3.9%)		0/157 (0%)
Rash	1/319 (0.3%)		3/321 (0.9%)		4/320 (1.3%)		0/184 (0%)		2/233 (0.9%)		6/175 (3.4%)		5/172 (2.9%)		6/176 (3.4%)		2/103 (1.9%)		2/157 (1.3%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.