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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02407236
Registration number
NCT02407236
Ethics application status
Date submitted
30/03/2015
Date registered
2/04/2015
Date last updated
5/01/2023
Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
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Scientific 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
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Secondary ID [1]
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2014-005606-38
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Secondary ID [2]
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CR106920
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Universal Trial Number (UTN)
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Trial acronym
UNIFI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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Inflammatory Bowel Diseases
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo IV
Treatment: Drugs - Placebo SC
Treatment: Drugs - Ustekinumab IV
Treatment: Drugs - Ustekinumab SC
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Treatment: Drugs: Placebo IV
Placebo will be administered as intravenous infusion.
Treatment: Drugs: Placebo SC
Placebo will be administered Subcutaneously.
Treatment: Drugs: Ustekinumab IV
Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Treatment: Drugs: Ustekinumab SC
Ustekinumab will be administered as subcutaneously.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 8
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Primary outcome [2]
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Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition)
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Assessment method [2]
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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.
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Timepoint [2]
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Week 8
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Primary outcome [3]
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Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition)
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Assessment method [3]
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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.
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Timepoint [3]
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Week 44
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Primary outcome [4]
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Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition)
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Assessment method [4]
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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.
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Timepoint [4]
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Week 44
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Secondary outcome [1]
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Induction Study: Number of Participants With Endoscopic Healing at Week 8
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Assessment method [1]
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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.
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Timepoint [1]
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Week 8
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Secondary outcome [2]
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Induction Study: Number of Participants With Clinical Response at Week 8
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Assessment method [2]
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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.
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Timepoint [2]
0
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Week 8
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Secondary outcome [3]
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Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and Week 8
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Secondary outcome [4]
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Maintenance Study: Number of Participants With Clinical Response up to Week 44
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Assessment method [4]
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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.
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Timepoint [4]
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Up to Week 44
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Secondary outcome [5]
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Maintenance Study: Number of Participants With Endoscopic Healing at Week 44
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Assessment method [5]
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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.
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Timepoint [5]
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Week 44
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Secondary outcome [6]
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Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition)
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Assessment method [6]
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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.
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Timepoint [6]
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Week 44
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Secondary outcome [7]
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Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition)
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Assessment method [7]
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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.
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Timepoint [7]
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Week 44
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Secondary outcome [8]
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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)
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Assessment method [8]
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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.
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Timepoint [8]
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Up to Week 44
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Secondary outcome [9]
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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)
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Assessment method [9]
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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.
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Timepoint [9]
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Up to Week 44
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Secondary outcome [10]
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Induction Study - Number of Participants With Mucosal Healing at Week 8
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Assessment method [10]
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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.
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Timepoint [10]
0
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Week 8
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Secondary outcome [11]
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Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition)
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Assessment method [11]
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0
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.
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Timepoint [11]
0
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Week 8
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Secondary outcome [12]
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Induction Study - Number of Participants in Symptomatic Remission at Week 8
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Assessment method [12]
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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.
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Timepoint [12]
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0
Week 8
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Secondary outcome [13]
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Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8
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Assessment method [13]
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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.
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Timepoint [13]
0
0
Week 8
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Secondary outcome [14]
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Induction Study - Change From Baseline in Mayo Score at Week 8
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Assessment method [14]
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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.
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Timepoint [14]
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0
Baseline and Week 8
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Secondary outcome [15]
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Induction Study - Change From Baseline in Partial Mayo Score Through Week 8
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Assessment method [15]
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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.
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Timepoint [15]
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0
Baseline through Week 8
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Secondary outcome [16]
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0
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8
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Assessment method [16]
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0
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.
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Timepoint [16]
0
0
Up to Week 8
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Secondary outcome [17]
0
0
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8
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Assessment method [17]
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0
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.
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Timepoint [17]
0
0
Up to Week 8
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Secondary outcome [18]
0
0
Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8
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Assessment method [18]
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0
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.
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Timepoint [18]
0
0
Week 8
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Secondary outcome [19]
0
0
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8
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Assessment method [19]
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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.
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Timepoint [19]
0
0
Up to Week 8
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Secondary outcome [20]
0
0
Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition)
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Assessment method [20]
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0
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.
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Timepoint [20]
0
0
Week 8
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Secondary outcome [21]
0
0
Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition)
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Assessment method [21]
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0
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.
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Timepoint [21]
0
0
Week 8
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Secondary outcome [22]
0
0
Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status
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Assessment method [22]
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0
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.
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Timepoint [22]
0
0
Week 8
Query!
Secondary outcome [23]
0
0
Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status
Query!
Assessment method [23]
0
0
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.
Query!
Timepoint [23]
0
0
Week 8
Query!
Secondary outcome [24]
0
0
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)
Query!
Assessment method [24]
0
0
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.
Query!
Timepoint [24]
0
0
Week 8
Query!
Secondary outcome [25]
0
0
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)
Query!
Assessment method [25]
0
0
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.
Query!
Timepoint [25]
0
0
Week 8
Query!
Secondary outcome [26]
0
0
Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8
Query!
Assessment method [26]
0
0
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.
Query!
Timepoint [26]
0
0
Baseline through Week 8
Query!
Secondary outcome [27]
0
0
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
Query!
Assessment method [27]
0
0
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.
Query!
Timepoint [27]
0
0
Up to Week 8
Query!
Secondary outcome [28]
0
0
Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8
Query!
Assessment method [28]
0
0
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.
Query!
Timepoint [28]
0
0
Baseline through Week 8
Query!
Secondary outcome [29]
0
0
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
Query!
Assessment method [29]
0
0
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.
Query!
Timepoint [29]
0
0
Up to Week 8
Query!
Secondary outcome [30]
0
0
Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8
Query!
Assessment method [30]
0
0
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.
Query!
Timepoint [30]
0
0
Baseline through Week 8
Query!
Secondary outcome [31]
0
0
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
Query!
Assessment method [31]
0
0
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.
Query!
Timepoint [31]
0
0
Up to Week 8
Query!
Secondary outcome [32]
0
0
Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Query!
Assessment method [32]
0
0
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.
Query!
Timepoint [32]
0
0
Baseline and Week 8
Query!
Secondary outcome [33]
0
0
Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8
Query!
Assessment method [33]
0
0
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.
Query!
Timepoint [33]
0
0
Baseline and Week 8
Query!
Secondary outcome [34]
0
0
Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8
Query!
Assessment method [34]
0
0
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.
Query!
Timepoint [34]
0
0
Baseline and Week 8
Query!
Secondary outcome [35]
0
0
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8
Query!
Assessment method [35]
0
0
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.
Query!
Timepoint [35]
0
0
Baseline and Week 8
Query!
Secondary outcome [36]
0
0
Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8
Query!
Assessment method [36]
0
0
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.
Query!
Timepoint [36]
0
0
Baseline and Week 8
Query!
Secondary outcome [37]
0
0
Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8
Query!
Assessment method [37]
0
0
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.
Query!
Timepoint [37]
0
0
Baseline and Week 8
Query!
Secondary outcome [38]
0
0
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8
Query!
Assessment method [38]
0
0
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.
Query!
Timepoint [38]
0
0
Baseline and Week 8
Query!
Secondary outcome [39]
0
0
Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44
Query!
Assessment method [39]
0
0
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.
Query!
Timepoint [39]
0
0
Baseline and Week 44
Query!
Secondary outcome [40]
0
0
Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44
Query!
Assessment method [40]
0
0
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.
Query!
Timepoint [40]
0
0
Induction Baseline and Week 44
Query!
Secondary outcome [41]
0
0
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44
Query!
Assessment method [41]
0
0
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.
Query!
Timepoint [41]
0
0
Up to Week 44
Query!
Secondary outcome [42]
0
0
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44
Query!
Assessment method [42]
0
0
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.
Query!
Timepoint [42]
0
0
Up to Week 44
Query!
Secondary outcome [43]
0
0
Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44
Query!
Assessment method [43]
0
0
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.
Query!
Timepoint [43]
0
0
Week 44
Query!
Secondary outcome [44]
0
0
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44
Query!
Assessment method [44]
0
0
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.
Query!
Timepoint [44]
0
0
Up to Week 44
Query!
Secondary outcome [45]
0
0
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44
Query!
Assessment method [45]
0
0
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.
Query!
Timepoint [45]
0
0
Baseline through Week 44
Query!
Secondary outcome [46]
0
0
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44
Query!
Assessment method [46]
0
0
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.
Query!
Timepoint [46]
0
0
Baseline through Week 44
Query!
Secondary outcome [47]
0
0
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
Query!
Assessment method [47]
0
0
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.
Query!
Timepoint [47]
0
0
Week 44
Query!
Secondary outcome [48]
0
0
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
Query!
Assessment method [48]
0
0
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.
Query!
Timepoint [48]
0
0
Week 44
Query!
Secondary outcome [49]
0
0
Maintenance Study: Number of Participants in Symptomatic Remission at Week 44
Query!
Assessment method [49]
0
0
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.
Query!
Timepoint [49]
0
0
Week 44
Query!
Secondary outcome [50]
0
0
Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition)
Query!
Assessment method [50]
0
0
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.
Query!
Timepoint [50]
0
0
Week 44
Query!
Secondary outcome [51]
0
0
Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition)
Query!
Assessment method [51]
0
0
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.
Query!
Timepoint [51]
0
0
Week 44
Query!
Secondary outcome [52]
0
0
Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status
Query!
Assessment method [52]
0
0
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.
Query!
Timepoint [52]
0
0
Up to Week 44
Query!
Secondary outcome [53]
0
0
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status
Query!
Assessment method [53]
0
0
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.
Query!
Timepoint [53]
0
0
Week 44
Query!
Secondary outcome [54]
0
0
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline
Query!
Assessment method [54]
0
0
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.
Query!
Timepoint [54]
0
0
Week 44
Query!
Secondary outcome [55]
0
0
Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44
Query!
Assessment method [55]
0
0
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.
Query!
Timepoint [55]
0
0
Week 44
Query!
Secondary outcome [56]
0
0
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)
Query!
Assessment method [56]
0
0
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.
Query!
Timepoint [56]
0
0
Week 44
Query!
Secondary outcome [57]
0
0
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)
Query!
Assessment method [57]
0
0
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.
Query!
Timepoint [57]
0
0
Week 44
Query!
Secondary outcome [58]
0
0
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
Query!
Assessment method [58]
0
0
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.
Query!
Timepoint [58]
0
0
Baseline Through Week 44
Query!
Secondary outcome [59]
0
0
Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline
Query!
Assessment method [59]
0
0
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.
Query!
Timepoint [59]
0
0
Week 44
Query!
Secondary outcome [60]
0
0
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
Query!
Assessment method [60]
0
0
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.
Query!
Timepoint [60]
0
0
Up to Week 44
Query!
Secondary outcome [61]
0
0
Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44
Query!
Assessment method [61]
0
0
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.
Query!
Timepoint [61]
0
0
Baseline, Week 20, and 44
Query!
Secondary outcome [62]
0
0
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44
Query!
Assessment method [62]
0
0
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.
Query!
Timepoint [62]
0
0
Baseline, Week 20, and 44
Query!
Secondary outcome [63]
0
0
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
Query!
Assessment method [63]
0
0
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.
Query!
Timepoint [63]
0
0
Baseline, Weeks 20, and 44
Query!
Secondary outcome [64]
0
0
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44
Query!
Assessment method [64]
0
0
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.
Query!
Timepoint [64]
0
0
Baseline, Weeks 20, and 44
Query!
Secondary outcome [65]
0
0
Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44
Query!
Assessment method [65]
0
0
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.
Query!
Timepoint [65]
0
0
Baseline, Weeks 20, and 44
Query!
Secondary outcome [66]
0
0
Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44
Query!
Assessment method [66]
0
0
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.
Query!
Timepoint [66]
0
0
Baseline, Weeks 20 and 44
Query!
Secondary outcome [67]
0
0
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44
Query!
Assessment method [67]
0
0
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.
Query!
Timepoint [67]
0
0
Baseline, Weeks 20, and 44
Query!
Secondary outcome [68]
0
0
Maintenance Study: Number of Participants With Mucosal Healing at Week 44
Query!
Assessment method [68]
0
0
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.
Query!
Timepoint [68]
0
0
Week 44
Query!
Secondary outcome [69]
0
0
Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44
Query!
Assessment method [69]
0
0
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.
Query!
Timepoint [69]
0
0
Baseline, Weeks 8, 24, and 44
Query!
Secondary outcome [70]
0
0
Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44
Query!
Assessment method [70]
0
0
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.
Query!
Timepoint [70]
0
0
Baseline, Weeks 8, 24, and 44
Query!
Secondary outcome [71]
0
0
Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44
Query!
Assessment method [71]
0
0
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.
Query!
Timepoint [71]
0
0
Baseline, Weeks 8, 24, and 44
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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''
Query!
Study design
Purpose of the study
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/07/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/11/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
961
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Bedford
Query!
Recruitment hospital [2]
0
0
- Clayton
Query!
Recruitment hospital [3]
0
0
- Concord N/a
Query!
Recruitment hospital [4]
0
0
- Fitzroy
Query!
Recruitment hospital [5]
0
0
- Five Dock
Query!
Recruitment hospital [6]
0
0
- Garran
Query!
Recruitment hospital [7]
0
0
- Heidelberg
Query!
Recruitment hospital [8]
0
0
- Liverpool
Query!
Recruitment hospital [9]
0
0
- Melbourne
Query!
Recruitment hospital [10]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [1]
0
0
- Bedford
Query!
Recruitment postcode(s) [2]
0
0
- Clayton
Query!
Recruitment postcode(s) [3]
0
0
- Concord N/a
Query!
Recruitment postcode(s) [4]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [5]
0
0
- Five Dock
Query!
Recruitment postcode(s) [6]
0
0
- Garran
Query!
Recruitment postcode(s) [7]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [8]
0
0
- Liverpool
Query!
Recruitment postcode(s) [9]
0
0
- Melbourne
Query!
Recruitment postcode(s) [10]
0
0
- South Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Minnesota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Mississippi
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oregon
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Tennessee
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Utah
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Virginia
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Washington
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Salzburg
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Wien
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Antwerpen
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Gent
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Kortrijk
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Leuven
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Liege
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Liège
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Roeselaere
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Pleven
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Rousse
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Sevlievo
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Sofia
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Varna
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
British Columbia
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Manitoba
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Ontario
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Quebec
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Hradec Kralove
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Plzen
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Prague 4
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Praha 5
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Praha 7
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Praha 9
Query!
Country [53]
0
0
Denmark
Query!
State/province [53]
0
0
Aarhus
Query!
Country [54]
0
0
Denmark
Query!
State/province [54]
0
0
Odense
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Amiens
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Bordeaux
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Lille
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Lyon
Query!
Country [59]
0
0
France
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State/province [59]
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0
Marseille
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Country [60]
0
0
France
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State/province [60]
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0
Montpellier
Query!
Country [61]
0
0
France
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State/province [61]
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0
Pierre-Benite
Query!
Country [62]
0
0
France
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State/province [62]
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Reims
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Country [63]
0
0
France
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Rennes
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Country [64]
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0
France
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Saint-Etienne
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Country [65]
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France
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Toulouse
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Germany
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Berlin
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Country [67]
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Germany
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Essen
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Country [68]
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Germany
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Freiburg
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Country [69]
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Germany
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Hannover
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Country [70]
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Germany
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Kiel
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Country [71]
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Germany
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Leipzig
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Country [72]
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Germany
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Lüneburg
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Country [73]
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Germany
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Mannheim
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Country [74]
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Germany
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Minden
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Germany
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Münster
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Hungary
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Balatonfüred
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Country [77]
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Hungary
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Budapest
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Country [78]
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Hungary
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Békéscsaba
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Country [79]
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Hungary
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Debrecen
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Country [80]
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Hungary
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State/province [80]
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Miskolc
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Country [81]
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Hungary
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Mosonmagyarovar
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Hungary
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Szekszárd
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Country [83]
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Hungary
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State/province [83]
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Szombathely
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Country [84]
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Hungary
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Székesfehérvár
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Hungary
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Vac
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Israel
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Beersheba
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Country [87]
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Israel
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Haifa
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Country [88]
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Israel
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Holon
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Country [89]
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Israel
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Jerusalem
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Country [90]
0
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Israel
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State/province [90]
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Kfar-Saba
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Country [91]
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Israel
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State/province [91]
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Nahariya
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Country [92]
0
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Israel
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State/province [92]
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Petach Tikvah
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Country [93]
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0
Israel
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State/province [93]
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Tel Aviv
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Country [94]
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Israel
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State/province [94]
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Tel Hashomer
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Country [95]
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Japan
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State/province [95]
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Ageo-shi
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Japan
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State/province [96]
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Asahikawa
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Country [97]
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Japan
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State/province [97]
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Bunkyo-Ku
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Japan
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State/province [98]
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Chiba
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Country [99]
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Japan
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State/province [99]
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Chikushinoshi
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Country [100]
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Japan
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State/province [100]
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Fujiidera
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Country [101]
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Japan
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State/province [101]
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Fukuoka-ken
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Japan
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Higashi-Ibaraki
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Japan
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Hirosaki
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Country [104]
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Japan
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State/province [104]
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Hiroshima
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Country [105]
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Japan
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State/province [105]
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Isesaki
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Country [106]
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Japan
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State/province [106]
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Iwate
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Country [107]
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Japan
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State/province [107]
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Izumo
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Country [108]
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Japan
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State/province [108]
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Kagawa
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Country [109]
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Japan
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State/province [109]
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Kagoshima
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Country [110]
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Japan
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State/province [110]
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Kahoku
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Country [111]
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Japan
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State/province [111]
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Kobe-shi
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Country [112]
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Japan
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State/province [112]
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Kochi
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Country [113]
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0
Japan
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State/province [113]
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Kurume
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Country [114]
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0
Japan
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State/province [114]
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Kyoto
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Country [115]
0
0
Japan
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State/province [115]
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Midori-ku
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Country [116]
0
0
Japan
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State/province [116]
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Nagasaki
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Country [117]
0
0
Japan
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State/province [117]
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Nara
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Country [118]
0
0
Japan
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State/province [118]
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0
Nishinomiya
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Country [119]
0
0
Japan
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State/province [119]
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0
Oita
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Country [120]
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0
Japan
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State/province [120]
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Osaka
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Country [121]
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0
Japan
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State/province [121]
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Saga-ken
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Country [122]
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Japan
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State/province [122]
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Saga
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Country [123]
0
0
Japan
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State/province [123]
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Saitama
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Country [124]
0
0
Japan
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State/province [124]
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Sakura
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Country [125]
0
0
Japan
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State/province [125]
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Sapporo
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Country [126]
0
0
Japan
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State/province [126]
0
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Sendai
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Country [127]
0
0
Japan
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State/province [127]
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0
Shizuoka
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Country [128]
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Japan
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State/province [128]
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0
Sunto-gun
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Country [129]
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0
Japan
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State/province [129]
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0
Takamatsu
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Country [130]
0
0
Japan
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Tokorozawa
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Country [131]
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0
Japan
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State/province [131]
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Tokyo
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Country [132]
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0
Japan
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State/province [132]
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Toyama
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Country [133]
0
0
Japan
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State/province [133]
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Toyota
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Country [134]
0
0
Japan
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State/province [134]
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Tsuchiura
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Country [135]
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0
Japan
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0
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Tsu
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Country [136]
0
0
Japan
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State/province [136]
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0
Wakayama
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Country [137]
0
0
Japan
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State/province [137]
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0
Yamanashi
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Country [138]
0
0
Korea, Republic of
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State/province [138]
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0
Daegu
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Country [139]
0
0
Korea, Republic of
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State/province [139]
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0
Guri-si
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Country [140]
0
0
Korea, Republic of
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State/province [140]
0
0
Seoul
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Country [141]
0
0
Korea, Republic of
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State/province [141]
0
0
Suwon-si
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Country [142]
0
0
Netherlands
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0
Amsterdam
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Country [143]
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0
Netherlands
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Maastricht
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0
New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Lower Hutt
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Country [148]
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New Zealand
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Milford
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Country [149]
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0
Poland
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Gdansk
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Country [150]
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Pulawy
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Poland
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Sopot
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Country [157]
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Romania
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Bucuresti
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Country [158]
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Romania
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State/province [158]
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Oradea
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Country [159]
0
0
Romania
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State/province [159]
0
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Romania
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Country [160]
0
0
Romania
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State/province [160]
0
0
Timisoara
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Country [161]
0
0
Russian Federation
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State/province [161]
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0
Irkutsk
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Country [162]
0
0
Russian Federation
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State/province [162]
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Kazan
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Country [163]
0
0
Russian Federation
Query!
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0
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Moscow
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Country [164]
0
0
Russian Federation
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State/province [164]
0
0
Moscva
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Country [165]
0
0
Russian Federation
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State/province [165]
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0
Novosibirsk
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Country [166]
0
0
Russian Federation
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Rostov-on-Don
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Country [167]
0
0
Russian Federation
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State/province [167]
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Ryazan
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Country [168]
0
0
Russian Federation
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State/province [168]
0
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Saint Petersburg
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Country [169]
0
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Russian Federation
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State/province [169]
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St Petersburg
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Country [170]
0
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Russian Federation
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State/province [170]
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0
St.-Petersburg
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Country [171]
0
0
Russian Federation
Query!
State/province [171]
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Stavropol
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Country [172]
0
0
Russian Federation
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State/province [172]
0
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Ufa
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Country [173]
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0
Serbia
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State/province [173]
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Belgrade
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Country [174]
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0
Serbia
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State/province [174]
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0
Kragujevac
Query!
Country [175]
0
0
Serbia
Query!
State/province [175]
0
0
Nis
Query!
Country [176]
0
0
Serbia
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State/province [176]
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0
Vojvodina
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Country [177]
0
0
Slovakia
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State/province [177]
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Bratislava
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Country [178]
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Slovakia
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State/province [178]
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Presov
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Country [179]
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Ukraine
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State/province [179]
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Chernivtsi
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Country [180]
0
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Ukraine
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State/province [180]
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0
Dnipropetrovsk
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Country [181]
0
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Ukraine
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State/province [181]
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0
Ivano-Frankivsk
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Country [182]
0
0
Ukraine
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State/province [182]
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Kharkiv
Query!
Country [183]
0
0
Ukraine
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State/province [183]
0
0
Kiyv
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Country [184]
0
0
Ukraine
Query!
State/province [184]
0
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Kyiv
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Country [185]
0
0
Ukraine
Query!
State/province [185]
0
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Lviv
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Country [186]
0
0
Ukraine
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State/province [186]
0
0
Odessa
Query!
Country [187]
0
0
Ukraine
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State/province [187]
0
0
Sumy
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Country [188]
0
0
Ukraine
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State/province [188]
0
0
Uzhgorod
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Country [189]
0
0
Ukraine
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State/province [189]
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0
Vinnytsia
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Country [190]
0
0
Ukraine
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State/province [190]
0
0
Zaporizhzhia
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Country [191]
0
0
Ukraine
Query!
State/province [191]
0
0
Zhaporozhia
Query!
Country [192]
0
0
United Kingdom
Query!
State/province [192]
0
0
Birmingham
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Country [193]
0
0
United Kingdom
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State/province [193]
0
0
Cambridge
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Country [194]
0
0
United Kingdom
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State/province [194]
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Coventry
Query!
Country [195]
0
0
United Kingdom
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State/province [195]
0
0
Doncaster
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Country [196]
0
0
United Kingdom
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State/province [196]
0
0
Edinburgh
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Country [197]
0
0
United Kingdom
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State/province [197]
0
0
Liverpool
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Country [198]
0
0
United Kingdom
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State/province [198]
0
0
London
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Country [199]
0
0
United Kingdom
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State/province [199]
0
0
Salford
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Country [200]
0
0
United Kingdom
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State/province [200]
0
0
Southampton
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Country [201]
0
0
United Kingdom
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State/province [201]
0
0
Sutton In Ashfield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Janssen Research & Development, LLC
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Address
Query!
Country
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Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02407236
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02407236
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