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A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02349061
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : June 12, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: Ustekinumab IV
Drug: Placebo Infusion
Drug: Placebo SC
Drug: Ustekinumab SC
Other: Concomitant Medication
Enrollment 102
Recruitment Details  
Pre-assignment Details 166 participants were screened during the study, 102 were enrolled/randomized and treated.
Arm/Group Title Placebo - Ustekinumab Ustekinumab Placebo to Ustekinumab
Hide Arm/Group Description 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. 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. 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.
Period Title: Main Study: PCP (Up to Week 24)
Started 42 60 0
Completed 33 56 0
Not Completed 9 4 0
Reason Not Completed
Adverse Event             4             3             0
Lack of Efficacy             1             0             0
Physician Decision             1             0             0
Other             1             1             0
Withdrawal by Subject             2             0             0
Period Title: Main Study: Week 24 to 56
Started 0 56 33
Completed 0 53 30
Not Completed 0 3 3
Reason Not Completed
Adverse Event             0             2             1
Lack of Efficacy             0             1             0
Withdrawal by Subject             0             0             1
Physician Decision             0             0             1
Period Title: Study Extension (Week 56 to Week 120)
Started 0 29 [1] 17 [1]
Completed 0 24 14
Not Completed 0 5 3
Reason Not Completed
Adverse Event             0             3             0
Lack of Efficacy             0             0             1
Withdrawal by Subject             0             2             1
Physician Decision             0             0             1
[1]
Who met study extension inclusion criteria received open-label ustekinumab SC through Week 104.
Arm/Group Title Placebo - Ustekinumab Ustekinumab Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 42 60 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 60 participants 102 participants
43.1  (11.03) 40  (11.95) 41.3  (11.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
Female
35
  83.3%
58
  96.7%
93
  91.2%
Male
7
  16.7%
2
   3.3%
9
   8.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
Hispanic or Latino
12
  28.6%
20
  33.3%
32
  31.4%
Not Hispanic or Latino
30
  71.4%
40
  66.7%
70
  68.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
American Indian or Alaska Native
0
   0.0%
1
   1.7%
1
   1.0%
Asian
6
  14.3%
8
  13.3%
14
  13.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.1%
4
   6.7%
7
   6.9%
White
28
  66.7%
42
  70.0%
70
  68.6%
More than one race
5
  11.9%
4
   6.7%
9
   8.8%
Unknown or Not Reported
0
   0.0%
1
   1.7%
1
   1.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
Asian
6
  14.3%
8
  13.3%
14
  13.7%
Black or African American
3
   7.1%
4
   6.7%
7
   6.9%
Hispanic or Latino
7
  16.7%
13
  21.7%
20
  19.6%
Other
5
  11.9%
6
  10.0%
11
  10.8%
White Non-Hispanic
21
  50.0%
29
  48.3%
50
  49.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
Argentina
4
   9.5%
8
  13.3%
12
  11.8%
Australia
2
   4.8%
3
   5.0%
5
   4.9%
Germany
2
   4.8%
3
   5.0%
5
   4.9%
Hungary
4
   9.5%
4
   6.7%
8
   7.8%
Mexico
6
  14.3%
5
   8.3%
11
  10.8%
Poland
7
  16.7%
12
  20.0%
19
  18.6%
Spain
5
  11.9%
7
  11.7%
12
  11.8%
Taiwan, Province Of China
6
  14.3%
7
  11.7%
13
  12.7%
United States
6
  14.3%
11
  18.3%
17
  16.7%
1.Primary Outcome
Title Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24
Hide Description 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).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ustekinumab
Hide Arm/Group Description:
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
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.
Overall Number of Participants Analyzed 42 60
Measure Type: Number
Unit of Measure: Percentage of participants
33.3 61.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0057
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.28
Confidence Interval (2-Sided) 95%
1.41 to 7.63
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ustekinumab
Hide Arm/Group Description:
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
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.
Overall Number of Participants Analyzed 31 53
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.8  (5.39) -4.4  (2.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0929
Comments [Not Specified]
Method Mixed model repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-2.94 to 0.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Score at Week 24
Hide Description 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).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ustekinumab
Hide Arm/Group Description:
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
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.
Overall Number of Participants Analyzed 32 55
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.93  (2.168) -2.17  (1.915)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3944
Comments [Not Specified]
Method Mixed model repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.383
Confidence Interval (2-Sided) 95%
-1.271 to 0.506
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24
Hide Description 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').
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.
Arm/Group Title Placebo Ustekinumab
Hide Arm/Group Description:
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
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.
Overall Number of Participants Analyzed 42 60
Measure Type: Count of Participants
Unit of Measure: Participants
14
  33.3%
21
  35.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9939
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.43 to 2.34
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Number of Joints With Pain and Signs of Inflammation at Week 24
Hide Description 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).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo Ustekinumab
Hide Arm/Group Description:
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
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.
Overall Number of Participants Analyzed 31 51
Mean (Standard Deviation)
Unit of Measure: Joints
-2.8  (7.31) -4.5  (4.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1032
Comments [Not Specified]
Method Mixed model repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -2.17
Confidence Interval (2-Sided) 95%
-4.78 to 0.45
Estimation Comments [Not Specified]
Time Frame Screening up to Week 120
Adverse Event Reporting Description Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously [IV] or subcutaneously [SC]) of ustekinumab or placebo.
 
Arm/Group Title Placebo (Up to Week 24) Ustekinumab (Up to Week 24) Placebo to Ustekinumab (Week 24 to 56) Ustekinumab (Week 24 to 56) Placebo to Ustekinumab (Week 56 to 120) Ustekinumab (Week 56 to 120)
Hide Arm/Group Description Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16. 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. 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. 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. 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. 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.
All-Cause Mortality
Placebo (Up to Week 24) Ustekinumab (Up to Week 24) Placebo to Ustekinumab (Week 24 to 56) Ustekinumab (Week 24 to 56) Placebo to Ustekinumab (Week 56 to 120) Ustekinumab (Week 56 to 120)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/60 (0.00%)   0/33 (0.00%)   0/56 (0.00%)   0/17 (0.00%)   0/29 (0.00%) 
Hide Serious Adverse Events
Placebo (Up to Week 24) Ustekinumab (Up to Week 24) Placebo to Ustekinumab (Week 24 to 56) Ustekinumab (Week 24 to 56) Placebo to Ustekinumab (Week 56 to 120) Ustekinumab (Week 56 to 120)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/42 (9.52%)   5/60 (8.33%)   5/33 (15.15%)   7/56 (12.50%)   1/17 (5.88%)   4/29 (13.79%) 
Blood and lymphatic system disorders             
Hypochromic Anaemia * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Cardiac disorders             
Coronary Artery Occlusion * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Gastrointestinal disorders             
Gastric Ulcer * 1  1/42 (2.38%)  0/60 (0.00%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Pancreatitis Acute * 1  0/42 (0.00%)  1/60 (1.67%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
General disorders             
Pyrexia * 1  1/42 (2.38%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  0/29 (0.00%) 
Immune system disorders             
Anaphylactic Reaction * 1  0/42 (0.00%)  1/60 (1.67%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Infections and infestations             
Bacteraemia * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  0/29 (0.00%) 
Bronchitis * 1  0/42 (0.00%)  1/60 (1.67%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Cellulitis * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Neutropenic Sepsis * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  0/29 (0.00%) 
Pneumonia * 1  0/42 (0.00%)  1/60 (1.67%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Salmonella Sepsis * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Sinusitis * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Stenotrophomonas Infection * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  0/29 (0.00%) 
Urinary Tract Infection * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  0/29 (0.00%) 
Viral Infection * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Injury, poisoning and procedural complications             
Humerus Fracture * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders             
Systemic Lupus Erythematosus * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Keratoacanthoma * 1  1/42 (2.38%)  0/60 (0.00%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Nervous system disorders             
Ischaemic Stroke * 1  0/42 (0.00%)  1/60 (1.67%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Posterior Reversible Encephalopathy Syndrome * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Renal and urinary disorders             
Acute Kidney Injury * 1  1/42 (2.38%)  0/60 (0.00%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Glomerulonephritis * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Lupus Nephritis * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Vascular disorders             
Hypotension * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  0/29 (0.00%) 
Raynaud's Phenomenon * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Up to Week 24) Ustekinumab (Up to Week 24) Placebo to Ustekinumab (Week 24 to 56) Ustekinumab (Week 24 to 56) Placebo to Ustekinumab (Week 56 to 120) Ustekinumab (Week 56 to 120)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/42 (59.52%)   30/60 (50.00%)   21/33 (63.64%)   34/56 (60.71%)   8/17 (47.06%)   22/29 (75.86%) 
Blood and lymphatic system disorders             
Anaemia * 1  0/42 (0.00%)  0/60 (0.00%)  2/33 (6.06%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Leukopenia * 1  1/42 (2.38%)  0/60 (0.00%)  2/33 (6.06%)  4/56 (7.14%)  1/17 (5.88%)  4/29 (13.79%) 
Neutropenia * 1  1/42 (2.38%)  1/60 (1.67%)  2/33 (6.06%)  3/56 (5.36%)  1/17 (5.88%)  3/29 (10.34%) 
Eye disorders             
Dry Eye * 1  0/42 (0.00%)  0/60 (0.00%)  2/33 (6.06%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Gastrointestinal disorders             
Diarrhoea * 1  0/42 (0.00%)  4/60 (6.67%)  3/33 (9.09%)  3/56 (5.36%)  0/17 (0.00%)  0/29 (0.00%) 
Nausea * 1  2/42 (4.76%)  3/60 (5.00%)  1/33 (3.03%)  1/56 (1.79%)  0/17 (0.00%)  0/29 (0.00%) 
General disorders             
Fatigue * 1  0/42 (0.00%)  2/60 (3.33%)  2/33 (6.06%)  1/56 (1.79%)  0/17 (0.00%)  0/29 (0.00%) 
Pyrexia * 1  0/42 (0.00%)  3/60 (5.00%)  0/33 (0.00%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Hepatobiliary disorders             
Hypertransaminasaemia * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Infections and infestations             
Bronchitis * 1  0/42 (0.00%)  2/60 (3.33%)  1/33 (3.03%)  4/56 (7.14%)  0/17 (0.00%)  4/29 (13.79%) 
Gastroenteritis * 1  2/42 (4.76%)  1/60 (1.67%)  3/33 (9.09%)  0/56 (0.00%)  2/17 (11.76%)  0/29 (0.00%) 
Gastroenteritis Viral * 1  3/42 (7.14%)  0/60 (0.00%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Infected Bite * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Nasopharyngitis * 1  3/42 (7.14%)  6/60 (10.00%)  2/33 (6.06%)  6/56 (10.71%)  1/17 (5.88%)  2/29 (6.90%) 
Pharyngitis * 1  0/42 (0.00%)  3/60 (5.00%)  1/33 (3.03%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Pharyngotonsillitis * 1  0/42 (0.00%)  3/60 (5.00%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Respiratory Tract Infection * 1  0/42 (0.00%)  0/60 (0.00%)  0/33 (0.00%)  2/56 (3.57%)  0/17 (0.00%)  2/29 (6.90%) 
Tinea Versicolour * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Tooth Abscess * 1  0/42 (0.00%)  1/60 (1.67%)  1/33 (3.03%)  3/56 (5.36%)  0/17 (0.00%)  3/29 (10.34%) 
Tooth Infection * 1  0/42 (0.00%)  1/60 (1.67%)  2/33 (6.06%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Upper Respiratory Tract Infection * 1  9/42 (21.43%)  5/60 (8.33%)  3/33 (9.09%)  10/56 (17.86%)  1/17 (5.88%)  3/29 (10.34%) 
Urinary Tract Infection * 1  4/42 (9.52%)  6/60 (10.00%)  6/33 (18.18%)  10/56 (17.86%)  2/17 (11.76%)  6/29 (20.69%) 
Vulvitis * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Injury, poisoning and procedural complications             
Limb Injury * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Investigations             
Alanine Aminotransferase Increased * 1  2/42 (4.76%)  1/60 (1.67%)  1/33 (3.03%)  2/56 (3.57%)  1/17 (5.88%)  1/29 (3.45%) 
Aspartate Aminotransferase Increased * 1  1/42 (2.38%)  2/60 (3.33%)  1/33 (3.03%)  1/56 (1.79%)  1/17 (5.88%)  1/29 (3.45%) 
Metabolism and nutrition disorders             
Diabetes Mellitus * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia * 1  3/42 (7.14%)  0/60 (0.00%)  0/33 (0.00%)  0/56 (0.00%)  0/17 (0.00%)  0/29 (0.00%) 
Back Pain * 1  2/42 (4.76%)  2/60 (3.33%)  0/33 (0.00%)  5/56 (8.93%)  0/17 (0.00%)  1/29 (3.45%) 
Systemic Lupus Erythematosus * 1  2/42 (4.76%)  3/60 (5.00%)  2/33 (6.06%)  2/56 (3.57%)  1/17 (5.88%)  2/29 (6.90%) 
Nervous system disorders             
Headache * 1  5/42 (11.90%)  4/60 (6.67%)  1/33 (3.03%)  3/56 (5.36%)  0/17 (0.00%)  2/29 (6.90%) 
Renal and urinary disorders             
Proteinuria * 1  1/42 (2.38%)  0/60 (0.00%)  0/33 (0.00%)  2/56 (3.57%)  0/17 (0.00%)  2/29 (6.90%) 
Reproductive system and breast disorders             
Menstruation Irregular * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Ovarian Cyst * 1  0/42 (0.00%)  0/60 (0.00%)  2/33 (6.06%)  1/56 (1.79%)  0/17 (0.00%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders             
Actinic Keratosis * 1  1/42 (2.38%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
Skin Lesion * 1  1/42 (2.38%)  0/60 (0.00%)  1/33 (3.03%)  1/56 (1.79%)  1/17 (5.88%)  1/29 (3.45%) 
Vascular disorders             
Peripheral Arterial Occlusive Disease * 1  0/42 (0.00%)  0/60 (0.00%)  1/33 (3.03%)  0/56 (0.00%)  1/17 (5.88%)  0/29 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Development
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02349061    
Other Study ID Numbers: CR106661
CNTO1275SLE2001 ( Other Identifier: Janssen Research & Development, LLC )
2014-005000-19 ( EudraCT Number )
First Submitted: January 23, 2015
First Posted: January 28, 2015
Results First Submitted: May 15, 2018
Results First Posted: June 12, 2018
Last Update Posted: March 24, 2020