Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1) (NCT NCT01369329)
NCT ID: NCT01369329
Last Updated: 2016-12-07
Results Overview
Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
769 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2016-12-07
Participant Flow
A total of 769 participants were randomly assigned to receive study agent. The analyses (efficacy) was based on the 741 participants who were randomized after the study was restarted.
In November 2011, due to stability issue with the batch of the intravenous (IV) drug (130 mg Ustekinumab) sponsor temporarily suspended dosing of participants with ustekinumab. Later study was restarted with 90 milligram per milliliter (mg/ml).
Participant milestones
| Measure |
Placebo
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Participants randomized to receive tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
256
|
254
|
259
|
|
Overall Study
COMPLETED
|
244
|
243
|
245
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Participants randomized to receive tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
10
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
|
Overall Study
Other
|
2
|
3
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
Baseline characteristics by cohort
| Measure |
Placebo
n=256 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
n=254 Participants
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=259 Participants
Participants randomized to receive tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
Total
n=769 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 11.74 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 12.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
440 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
329 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
8 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
France
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
29 participants
n=5 Participants
|
67 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
16 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Ireland
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=5 Participants
|
108 participants
n=7 Participants
|
97 participants
n=5 Participants
|
331 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Efficacy analyses set included all the participants who were randomized after the study was restarted.
Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Outcome measures
| Measure |
Placebo
n=247 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
n=245 Participants
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=249 Participants
Participants randomized to receive tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Number of Participants With Clinical Response at Week 6
|
53 participants
|
84 participants
|
84 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Efficacy analyses set included all the participants who were randomized after the study was restarted.
Clinical remission is defined as a CDAI score of less than (\<) 150 points at Week 8.
Outcome measures
| Measure |
Placebo
n=247 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
n=245 Participants
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=249 Participants
Participants randomized to receive tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Number of Participants in Clinical Remission at Week 8
|
18 participants
|
39 participants
|
52 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Efficacy analyses set included all the participants who were randomized after the study was restarted.
Clinical response at Week 8 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (\>=) 100 points. Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Outcome measures
| Measure |
Placebo
n=247 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
n=245 Participants
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=249 Participants
Participants randomized to receive tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Number of Participants in Clinical Response at Week 8
|
50 participants
|
82 participants
|
94 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Efficacy analyses set included all the participants who were randomized after the study was restarted.
70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Outcome measures
| Measure |
Placebo
n=247 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
n=245 Participants
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=249 Participants
Participants randomized to receive tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6
|
75 participants
|
113 participants
|
109 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 3Population: Efficacy analyses set included all the participants who were randomized after the study was restarted.
70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Outcome measures
| Measure |
Placebo
n=247 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
n=245 Participants
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=249 Participants
Participants randomized to receive tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Number of Participants With CDAI 70-point Response at Week 3
|
67 participants
|
94 participants
|
101 participants
|
Adverse Events
Placebo
Serious events: 18 serious events
Other events: 90 other events
Deaths: 0 deaths
Ustekinumab 130 Milligram (mg)
Serious events: 14 serious events
Other events: 95 other events
Deaths: 0 deaths
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Serious events: 18 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=254 participants at risk
Participants received a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
n=255 participants at risk
Participants received a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=259 participants at risk
Participants received tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Colonic Fistula
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Crohn's Disease
|
3.9%
10/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
2.7%
7/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
1.9%
5/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Dental Caries
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.79%
2/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
General disorders
Pyrexia
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Abscess Intestinal
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Anal Abscess
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Infected Fistula
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Meningitis Listeria
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Pelvic Abscess
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Perineal Abscess
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Pneumonia Viral
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Postoperative Abscess
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Vulval Abscess
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Investigations
Blood Electrolytes Abnormal
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.39%
1/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Vascular disorders
Phlebitis Superficial
|
0.00%
0/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.00%
0/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
Other adverse events
| Measure |
Placebo
n=254 participants at risk
Participants received a single dose of Placebo Intravenous (IV) infusion at week 0.
|
Ustekinumab 130 Milligram (mg)
n=255 participants at risk
Participants received a single dose of ustekinumab 130 milligram (mg) IV at week 0.
|
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=259 participants at risk
Participants received tiered ustekinumab dose approximately (\~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (\< =) 55 kg, ustekinumab 390 mg for weight greater than (\>) 55 kg and \< = 85 kg and ustekinumab 520 mg for weight \> 85 kg.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.5%
14/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
3.9%
10/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
5.4%
14/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Crohn's Disease
|
8.3%
21/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
3.1%
8/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
0.39%
1/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
18/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
7.8%
20/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
5.8%
15/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
General disorders
Fatigue
|
5.1%
13/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
2.4%
6/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
3.9%
10/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
General disorders
Pyrexia
|
5.5%
14/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
5.9%
15/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
5.8%
15/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
14/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
4.7%
12/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
4.6%
12/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
19/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
11.0%
28/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
5.8%
15/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
|
Nervous system disorders
Headache
|
8.7%
22/254 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
7.8%
20/255 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
7.7%
20/259 • Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER