Trial Outcomes & Findings for A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus (NCT NCT02349061)
NCT ID: NCT02349061
Last Updated: 2020-03-24
Results Overview
SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA). Composite response is defined as SRI-4 response in participants who do not meet treatment failure criteria. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well (0)-very poor (10).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Week 24
Results posted on
2020-03-24
Participant Flow
166 participants were screened during the study, 102 were enrolled/randomized and treated.
Participant milestones
| Measure |
Placebo - Ustekinumab
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16. At Week 24, participants who completed were crossed-over to receive ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
|
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16. Participants who completed placebo controlled period (PCP) continued to receive ustekinumab 90 mg at Weeks 24, 32, and 40 followed by safety follow-up for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
Placebo to Ustekinumab
Participants who received placebo matched to ustekinumab and completed PCP period in placebo group were crossed-over at Week 24 and received ustekinumab 90 mg SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
|---|---|---|---|
|
Main Study: PCP (Up to Week 24)
STARTED
|
42
|
60
|
0
|
|
Main Study: PCP (Up to Week 24)
COMPLETED
|
33
|
56
|
0
|
|
Main Study: PCP (Up to Week 24)
NOT COMPLETED
|
9
|
4
|
0
|
|
Main Study: Week 24 to 56
STARTED
|
0
|
56
|
33
|
|
Main Study: Week 24 to 56
COMPLETED
|
0
|
53
|
30
|
|
Main Study: Week 24 to 56
NOT COMPLETED
|
0
|
3
|
3
|
|
Study Extension (Week 56 to Week 120)
STARTED
|
0
|
29
|
17
|
|
Study Extension (Week 56 to Week 120)
COMPLETED
|
0
|
24
|
14
|
|
Study Extension (Week 56 to Week 120)
NOT COMPLETED
|
0
|
5
|
3
|
Reasons for withdrawal
| Measure |
Placebo - Ustekinumab
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16. At Week 24, participants who completed were crossed-over to receive ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
|
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16. Participants who completed placebo controlled period (PCP) continued to receive ustekinumab 90 mg at Weeks 24, 32, and 40 followed by safety follow-up for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
Placebo to Ustekinumab
Participants who received placebo matched to ustekinumab and completed PCP period in placebo group were crossed-over at Week 24 and received ustekinumab 90 mg SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
|---|---|---|---|
|
Main Study: PCP (Up to Week 24)
Adverse Event
|
4
|
3
|
0
|
|
Main Study: PCP (Up to Week 24)
Lack of Efficacy
|
1
|
0
|
0
|
|
Main Study: PCP (Up to Week 24)
Physician Decision
|
1
|
0
|
0
|
|
Main Study: PCP (Up to Week 24)
Other
|
1
|
1
|
0
|
|
Main Study: PCP (Up to Week 24)
Withdrawal by Subject
|
2
|
0
|
0
|
|
Main Study: Week 24 to 56
Adverse Event
|
0
|
2
|
1
|
|
Main Study: Week 24 to 56
Lack of Efficacy
|
0
|
1
|
0
|
|
Main Study: Week 24 to 56
Withdrawal by Subject
|
0
|
0
|
1
|
|
Main Study: Week 24 to 56
Physician Decision
|
0
|
0
|
1
|
|
Study Extension (Week 56 to Week 120)
Adverse Event
|
0
|
3
|
0
|
|
Study Extension (Week 56 to Week 120)
Lack of Efficacy
|
0
|
0
|
1
|
|
Study Extension (Week 56 to Week 120)
Withdrawal by Subject
|
0
|
2
|
1
|
|
Study Extension (Week 56 to Week 120)
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Placebo - Ustekinumab
n=42 Participants
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16. At Week 24, participants who completed were crossed-over to receive ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
|
Ustekinumab
n=60 Participants
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16. Participants who completed placebo controlled period (PCP) continued to receive ustekinumab 90 mg at Weeks 24, 32, and 40 followed by safety follow-up for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
40 years
STANDARD_DEVIATION 11.95 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full analysis set (FAS) included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.
SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA). Composite response is defined as SRI-4 response in participants who do not meet treatment failure criteria. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well (0)-very poor (10).
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
|
Ustekinumab
n=60 Participants
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
|
|---|---|---|
|
Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24
|
33.3 Percentage of participants
|
61.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE patients in the previous 30 days. It is weighted according to the feature. Features are scored by the assessing physician if present within the last 30 days with more severe features having higher scores, and then simply added to determine the total SLEDAI 2K score, which ranges from 0 to 105, with higher scores representing increased disease activity.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
|
Ustekinumab
n=53 Participants
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
|
|---|---|---|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24
|
-3.8 Units on a scale
Standard Deviation 5.39
|
-4.4 Units on a scale
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
PGA was recorded on a visual analogue scale (VAS; 0.0 to 10.0 centimeter \[cm\]). The scale for the physician's assessment ranges for 'no lupus activity' (0.0) to 'extremely active lupus' (10.0).
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
|
Ustekinumab
n=55 Participants
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
|
|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Score at Week 24
|
-1.93 Units on a scale
Standard Deviation 2.168
|
-2.17 Units on a scale
Standard Deviation 1.915
|
SECONDARY outcome
Timeframe: Week 24Population: FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.
BICLA response defined as participants meeting following criteria: 1. BILAG improvement (all BILAG A scores at baseline improved to either B, C or D and all BILAG B scores at baseline improved to C or D and no worsening in disease activity defined as no new BILAG A scores and \<= 1 new BILAG B score) and 2. no worsening of total SLEDAI-2K from baseline 3. \< 1 cm increase in PGA and 4. no treatment failure criteria met. BILAG: assesses disease extent, severity (range: A \[severe\] to E \[no disease\]). SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PGA: assesses worsening in participant's general health status (0.0= 'no lupus activity' to 10.0 = 'extremely active lupus').
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
|
Ustekinumab
n=60 Participants
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
|
|---|---|---|
|
Number of Participants With BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24
|
14 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Population included participants with at least 2 affected joints at baseline (2 or more affected joints).
Change from baseline in number of joints (active joint) with pain and signs of inflammation (tenderness, swelling or effusion) for participants with at least 2 affected joints at baseline were reported. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion).
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
|
Ustekinumab
n=51 Participants
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
|
|---|---|---|
|
Change From Baseline in Number of Joints With Pain and Signs of Inflammation at Week 24
|
-2.8 Joints
Standard Deviation 7.31
|
-4.5 Joints
Standard Deviation 4.42
|
Adverse Events
Placebo (Up to Week 24)
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Ustekinumab (Up to Week 24)
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo to Ustekinumab (Week 24 to 56)
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Ustekinumab (Week 24 to 56)
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo to Ustekinumab (Week 56 to 120)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Ustekinumab (Week 56 to 120)
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Up to Week 24)
n=42 participants at risk
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
|
Ustekinumab (Up to Week 24)
n=60 participants at risk
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Week 8 and 16.
|
Placebo to Ustekinumab (Week 24 to 56)
n=33 participants at risk
Participants who received placebo matched to ustekinumab and completed placebo controlled period (PCP) in placebo group were crossed-over at Week 24 and received ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
|
Ustekinumab (Week 24 to 56)
n=56 participants at risk
Participants who were assigned to Ustekinumab treatment and who completed PCP continued to receive ustekinumab 90 mg SC at Weeks 24, 32, and 40 followed by safety follow up for 16 weeks after last study agent SC administration.
|
Placebo to Ustekinumab (Week 56 to 120)
n=17 participants at risk
Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
Ustekinumab (Week 56 to 120)
n=29 participants at risk
Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
General disorders
Pyrexia
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Salmonella Sepsis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Stenotrophomonas Infection
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Nervous system disorders
Posterior Reversible Encephalopathy Syndrome
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Renal and urinary disorders
Lupus Nephritis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Vascular disorders
Hypotension
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Vascular disorders
Raynaud's Phenomenon
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
Other adverse events
| Measure |
Placebo (Up to Week 24)
n=42 participants at risk
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
|
Ustekinumab (Up to Week 24)
n=60 participants at risk
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Week 8 and 16.
|
Placebo to Ustekinumab (Week 24 to 56)
n=33 participants at risk
Participants who received placebo matched to ustekinumab and completed placebo controlled period (PCP) in placebo group were crossed-over at Week 24 and received ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
|
Ustekinumab (Week 24 to 56)
n=56 participants at risk
Participants who were assigned to Ustekinumab treatment and who completed PCP continued to receive ustekinumab 90 mg SC at Weeks 24, 32, and 40 followed by safety follow up for 16 weeks after last study agent SC administration.
|
Placebo to Ustekinumab (Week 56 to 120)
n=17 participants at risk
Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
Ustekinumab (Week 56 to 120)
n=29 participants at risk
Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
7.1%
4/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
13.8%
4/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.4%
3/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
10.3%
3/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Eye disorders
Dry Eye
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.7%
4/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
9.1%
3/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.4%
3/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
2/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.0%
3/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
General disorders
Fatigue
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.3%
2/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
General disorders
Pyrexia
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.0%
3/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.3%
2/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
7.1%
4/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
13.8%
4/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Gastroenteritis
|
4.8%
2/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
9.1%
3/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
11.8%
2/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Gastroenteritis Viral
|
7.1%
3/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Infected Bite
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
10.0%
6/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
10.7%
6/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.9%
2/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.0%
3/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.0%
3/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.6%
2/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.9%
2/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.4%
3/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
10.3%
3/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
21.4%
9/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
8.3%
5/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
9.1%
3/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
17.9%
10/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
10.3%
3/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Urinary Tract Infection
|
9.5%
4/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
10.0%
6/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
18.2%
6/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
17.9%
10/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
11.8%
2/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
20.7%
6/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.8%
2/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.7%
1/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.6%
2/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.3%
2/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
3/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.8%
2/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.3%
2/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
8.9%
5/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
4.8%
2/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.0%
3/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.6%
2/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.9%
2/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Nervous system disorders
Headache
|
11.9%
5/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.7%
4/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.4%
3/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.9%
2/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.6%
2/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.9%
2/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
6.1%
2/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
2.4%
1/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
1.8%
1/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.4%
1/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/42 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/60 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
3.0%
1/33 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/56 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
5.9%
1/17 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
0.00%
0/29 • Screening up to Week 120
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of ustekinumab or placebo.
|
Additional Information
Senior Director Clinical Development
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
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 o r 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