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Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2) (NCT NCT01369342)

NCT ID: NCT01369342

Last Updated: 2017-01-06

Results Overview

Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) 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 decrease in CDAI score over time indicates improvement in disease activity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

640 participants

Primary outcome timeframe

Week 6

Results posted on

2017-01-06

Participant Flow

A total of 640 participants were randomly assigned to receive study agent. The analyses (efficacy) were based on the 628 participants who were randomized after the study was restarted. However, one additional participant was excluded from efficacy analyses due to misconduct by the investigative site.

In November 2011, due to stability issue with the batch of the IV drug (130 mg Ustekinumab) sponsor temporarily suspended dosing of participants with ustekinumab. Study was restarted with 90 mg/ml on 17 February 2012.

Participant milestones

Participant milestones
Measure
Placebo IV
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
214
213
213
Overall Study
COMPLETED
201
204
210
Overall Study
NOT COMPLETED
13
9
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo IV
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
7
7
2
Overall Study
Lost to Follow-up
5
2
1
Overall Study
Not Treated
1
0
0

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo IV
n=214 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 Milligram (mg)
n=213 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=213 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=640 Participants
Total of all reporting groups
Age, Continuous
40.1 years
STANDARD_DEVIATION 13.09 • n=99 Participants
39.2 years
STANDARD_DEVIATION 13.74 • n=107 Participants
38.8 years
STANDARD_DEVIATION 13.65 • n=206 Participants
39.4 years
STANDARD_DEVIATION 13.48 • n=7 Participants
Gender
Female
113 Participants
n=99 Participants
107 Participants
n=107 Participants
122 Participants
n=206 Participants
342 Participants
n=7 Participants
Gender
Male
101 Participants
n=99 Participants
106 Participants
n=107 Participants
91 Participants
n=206 Participants
298 Participants
n=7 Participants
Region of Enrollment
Australia
8 participants
n=99 Participants
7 participants
n=107 Participants
5 participants
n=206 Participants
20 participants
n=7 Participants
Region of Enrollment
Belgium
1 participants
n=99 Participants
1 participants
n=107 Participants
2 participants
n=206 Participants
4 participants
n=7 Participants
Region of Enrollment
Bulgaria
8 participants
n=99 Participants
5 participants
n=107 Participants
11 participants
n=206 Participants
24 participants
n=7 Participants
Region of Enrollment
Brazil
2 participants
n=99 Participants
5 participants
n=107 Participants
2 participants
n=206 Participants
9 participants
n=7 Participants
Region of Enrollment
Canada
14 participants
n=99 Participants
18 participants
n=107 Participants
10 participants
n=206 Participants
42 participants
n=7 Participants
Region of Enrollment
Germany
19 participants
n=99 Participants
15 participants
n=107 Participants
13 participants
n=206 Participants
47 participants
n=7 Participants
Region of Enrollment
Spain
0 participants
n=99 Participants
1 participants
n=107 Participants
0 participants
n=206 Participants
1 participants
n=7 Participants
Region of Enrollment
France
3 participants
n=99 Participants
2 participants
n=107 Participants
5 participants
n=206 Participants
10 participants
n=7 Participants
Region of Enrollment
United Kingdom
8 participants
n=99 Participants
8 participants
n=107 Participants
5 participants
n=206 Participants
21 participants
n=7 Participants
Region of Enrollment
Croatia
1 participants
n=99 Participants
2 participants
n=107 Participants
1 participants
n=206 Participants
4 participants
n=7 Participants
Region of Enrollment
Hungary
23 participants
n=99 Participants
20 participants
n=107 Participants
18 participants
n=206 Participants
61 participants
n=7 Participants
Region of Enrollment
Iceland
0 participants
n=99 Participants
1 participants
n=107 Participants
1 participants
n=206 Participants
2 participants
n=7 Participants
Region of Enrollment
Israel
2 participants
n=99 Participants
3 participants
n=107 Participants
6 participants
n=206 Participants
11 participants
n=7 Participants
Region of Enrollment
Italy
2 participants
n=99 Participants
2 participants
n=107 Participants
5 participants
n=206 Participants
9 participants
n=7 Participants
Region of Enrollment
Japan
9 participants
n=99 Participants
8 participants
n=107 Participants
9 participants
n=206 Participants
26 participants
n=7 Participants
Region of Enrollment
Korea
7 participants
n=99 Participants
7 participants
n=107 Participants
6 participants
n=206 Participants
20 participants
n=7 Participants
Region of Enrollment
Netherland
1 participants
n=99 Participants
1 participants
n=107 Participants
2 participants
n=206 Participants
4 participants
n=7 Participants
Region of Enrollment
New Zealand
2 participants
n=99 Participants
8 participants
n=107 Participants
4 participants
n=206 Participants
14 participants
n=7 Participants
Region of Enrollment
Poland
8 participants
n=99 Participants
8 participants
n=107 Participants
10 participants
n=206 Participants
26 participants
n=7 Participants
Region of Enrollment
Russia
6 participants
n=99 Participants
6 participants
n=107 Participants
5 participants
n=206 Participants
17 participants
n=7 Participants
Region of Enrollment
Serbia
4 participants
n=99 Participants
8 participants
n=107 Participants
3 participants
n=206 Participants
15 participants
n=7 Participants
Region of Enrollment
United States
72 participants
n=99 Participants
72 participants
n=107 Participants
76 participants
n=206 Participants
220 participants
n=7 Participants
Region of Enrollment
South Africa
14 participants
n=99 Participants
5 participants
n=107 Participants
14 participants
n=206 Participants
33 participants
n=7 Participants

PRIMARY outcome

Timeframe: Week 6

Population: 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 (CDAI) 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 decrease in CDAI score over time indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure
Placebo
n=209 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 mg
n=209 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=209 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
60 participants
108 participants
116 participants

SECONDARY outcome

Timeframe: Week 8

Population: Efficacy analyses set included all the participants who were randomized after the study was restarted.

Clinical remission at Week 8 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points.

Outcome measures

Outcome measures
Measure
Placebo
n=209 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 mg
n=209 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=209 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
41 participants
64 participants
84 participants

SECONDARY outcome

Timeframe: Week 8

Population: 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 CDAI 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 decrease in CDAI score over time indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure
Placebo
n=209 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 mg
n=209 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=209 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
67 participants
99 participants
121 participants

SECONDARY outcome

Timeframe: Week 6

Population: 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 (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). 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

Outcome measures
Measure
Placebo
n=209 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 mg
n=209 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=209 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
81 participants
123 participants
135 participants

SECONDARY outcome

Timeframe: Week 3

Population: 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 (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). 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

Outcome measures
Measure
Placebo
n=209 Participants
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 mg
n=209 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=209 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
66 participants
103 participants
106 participants

Adverse Events

Placebo IV

Serious events: 15 serious events
Other events: 44 other events
Deaths: 0 deaths

Ustekinumab 130 Milligram (mg)

Serious events: 10 serious events
Other events: 40 other events
Deaths: 0 deaths

Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)

Serious events: 9 serious events
Other events: 44 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo IV
n=212 participants at risk
Participants received single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 Milligram (mg)
n=216 participants at risk
Participants received single dose of ustekinumab 130 milligram (mg) IV at week 0.
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=211 participants at risk
Participants received a single 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.
Blood and lymphatic system disorders
Anaemia
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.46%
1/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Blood and lymphatic system disorders
Pancytopenia
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Cardiac disorders
Atrial Fibrillation
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Gastrointestinal disorders
Colitis
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.47%
1/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Gastrointestinal disorders
Crohn's Disease
2.4%
5/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
2.3%
5/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.95%
2/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Gastrointestinal disorders
Diarrhoea
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.46%
1/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Gastrointestinal disorders
Intestinal Obstruction
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Gastrointestinal disorders
Localised Intraabdominal Fluid Collection
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.46%
1/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Gastrointestinal disorders
Small Intestinal Obstruction
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.46%
1/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.95%
2/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Gastrointestinal disorders
Small Intestinal Perforation
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
General disorders
Chest Pain
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.47%
1/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
General disorders
Impaired Healing
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.46%
1/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
General disorders
Non-Cardiac Chest Pain
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.46%
1/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Hepatobiliary disorders
Bile Duct Stone
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Infections and infestations
Anal Abscess
1.4%
3/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.93%
2/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Infections and infestations
Gastroenteritis
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.47%
1/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Infections and infestations
Genital Herpes
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Infections and infestations
Pneumonia
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Injury, poisoning and procedural complications
Incisional Hernia
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.46%
1/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Nervous system disorders
Headache
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Reproductive system and breast disorders
Dysmenorrhoea
0.47%
1/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Respiratory, thoracic and mediastinal disorders
Pneumothorax Spontaneous
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.46%
1/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.47%
1/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Respiratory, thoracic and mediastinal disorders
Pulmonary Granuloma
0.00%
0/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.00%
0/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
0.47%
1/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).

Other adverse events

Other adverse events
Measure
Placebo IV
n=212 participants at risk
Participants received single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 Milligram (mg)
n=216 participants at risk
Participants received single dose of ustekinumab 130 milligram (mg) IV at week 0.
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
n=211 participants at risk
Participants received a single 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
Nausea
2.4%
5/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
3.2%
7/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
5.2%
11/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
General disorders
Pyrexia
4.7%
10/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
2.8%
6/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
5.2%
11/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Infections and infestations
Nasopharyngitis
4.7%
10/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
4.6%
10/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
6.6%
14/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Infections and infestations
Upper Respiratory Tract Infection
5.2%
11/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
1.9%
4/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
3.3%
7/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
Nervous system disorders
Headache
6.6%
14/212 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
9.3%
20/216 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
4.7%
10/211 • 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)
1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).

Additional Information

Vice President

Janssen Research & Development, LLC

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