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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2014-005000-19
    Trial protocol
    		 HU   DE   ES   PL  
    Global end of trial date
    07 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2020
    First version publication date
    27 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR106661
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02349061
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jun 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety and tolerability were evaluated by vital signs, general physical examinations and skin evaluations, adverse events, concomitant medication review, pregnancy testing, administration reactions, chemistry and hematology laboratory tests, and antibodies to ustekinumab.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Oct 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 12
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Taiwan: 13
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    102
    EEA total number of subjects
    44
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    99
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 166 subjects were screened during the study, 102 were enrolled/randomized and treated.

    Period 1
    Period 1 title
    Main Study: PCP (Up to Week 24)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects received placebo matched to ustekinumab IV at Week 0 followed by placebo SC at Week 8 and 16.

    Arm title
    		 Ustekinumab
    Arm description
    		 Subjects received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 milligram (mg) SC administered every 8 weeks (q8w) at Week 8 and 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    STELARA
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects received 6 mg/kg of ustekinumab at Week 0 followed by ustekinumab 90 mg SC administered q8w at Week 8 and 16.

    Number of subjects in period 1
    		Placebo Ustekinumab
    Started
    42
    60
    Completed
    33
    56
    Not completed
    9
    4
         Physician decision
    1
    -
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    4
    3
         Unspecified
    1
    1
         Lack of efficacy
    1
    -
    Period 2
    Period 2 title
    Main Study: Week 24 to 56
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ustekinumab
    Arm description
    		 Subjects who were assigned to Ustekinumab treatment and who completed placebo controlled period (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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    STELARA
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab 90 mg SC administered q8w at Weeks 24, 32 and 40.

    Arm title
    		 Placebo to Ustekinumab
    Arm description
    		 Subjects 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    STELARA
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab 90 mg SC administered q8w at Weeks 24, 32 and 40.

    Number of subjects in period 2
    		Ustekinumab Placebo to Ustekinumab
    Started
    56
    33
    Completed
    53
    30
    Not completed
    3
    3
         Consent withdrawn by subject
    -
    1
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    1
         Lack of efficacy
    1
    -
    Period 3
    Period 3 title
    Study Extension (Week 56 to Week 120)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ustekinumab
    Arm description
    		 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 subjects followed by safety follow-up through Week 120.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    STELARA
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab 90 mg SC administered q8w starting at Week 48 or at Week 56 through Week 104.

    Arm title
    		 Placebo to Ustekinumab
    Arm description
    		 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 subjects followed by safety follow-up through Week 120.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    STELARA
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab 90 mg SC administered q8w starting at Week 48 or at Week 56 through Week 104.

    Number of subjects in period 3 [1]
    		Ustekinumab Placebo to Ustekinumab
    Started
    29
    17
    Completed
    24
    14
    Not completed
    5
    3
         Consent withdrawn by subject
    2
    1
         Physician decision
    -
    1
         Adverse event, non-fatal
    3
    -
         Lack of efficacy
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects who were eligible to continue in extension phase are included in this period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.

    Reporting group title
    Ustekinumab
    Reporting group description
    		 Subjects received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 milligram (mg) SC administered every 8 weeks (q8w) at Week 8 and 16.

    Reporting group values
    		 Placebo Ustekinumab Total
    Number of subjects
    		 42 60 102
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 42 57 99
        From 65 to 84 years
    		 0 3 3
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.1 ( 11.03 ) 40 ( 11.95 ) -
    Title for Gender
    Units: subjects
        Female
    		 35 58 93
        Male
    		 7 2 9

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.

    Reporting group title
    Ustekinumab
    Reporting group description
    		 Subjects received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 milligram (mg) SC administered every 8 weeks (q8w) at Week 8 and 16.
    Reporting group title
    Ustekinumab
    Reporting group description
    		 Subjects who were assigned to Ustekinumab treatment and who completed placebo controlled period (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.

    Reporting group title
    Placebo to Ustekinumab
    Reporting group description
    		 Subjects 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.
    Reporting group title
    Ustekinumab
    Reporting group description
    		 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 subjects followed by safety follow-up through Week 120.

    Reporting group title
    Placebo to Ustekinumab
    Reporting group description
    		 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 subjects followed by safety follow-up through Week 120.

    Primary: Percentage of Subjects with a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24

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    End point title
    		 Percentage of Subjects with a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24
    End point description
    SRI-4: greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new domain scores in either British Isles Lupus Assessment Group (BILAG) A or B and no worsening (less than 10% increase) from baseline in Physician’s Global Assessment of Disease Activity (PGA). CR; SRI-4 response in subjects who do not meet treatment failure criteria. SLEDAI-2K total score range = 0-105, higher score means increased disease activity. BILAG Index: assesses 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. PGA assess disease activity on a visual analogue scale range= 0-10 (very well-very poor). Full analysis set (FAS) included all randomized subjects who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Placebo Ustekinumab
    Number of subjects analysed
    42
    60
    Units: Percentage of subjects
        number (not applicable)
    33.3
    61.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ustekinumab
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0057
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 7.63

    Secondary: Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24

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    End point title
    		 Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24
    End point 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. FAS included all the randomized subjects who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Here, ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Placebo Ustekinumab
    Number of subjects analysed
    31
    53
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -3.8 ( 5.39 )
    -4.4 ( 2.91 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ustekinumab
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0929
    Method
    		 Mixed model repeated measures model
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.94
         upper limit
    		 0.23

    Secondary: Change from Baseline in Physician’s Global Assessment of Disease Activity (PGA) Score at Week 24

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    End point title
    		 Change from Baseline in Physician’s Global Assessment of Disease Activity (PGA) Score at Week 24
    End point 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). FAS included all the randomized subjects who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Here, ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Placebo Ustekinumab
    Number of subjects analysed
    32
    55
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.93 ( 2.168 )
    -2.17 ( 1.915 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ustekinumab
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3944
    Method
    		 Mixed model repeated measures model
    Parameter type
    		 LS Means Difference
    Point estimate
    -0.383
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.271
         upper limit
    		 0.506

    Secondary: Percentage of Subjects with BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24

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    End point title
    		 Percentage of Subjects with BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24
    End point description
    BICLA response defined as subjects 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 subject's general health status (0.0= ‘no lupus activity’ to 10.0 = ‘extremely active lupus’). FAS included all the randomized subjects who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Ustekinumab
    Number of subjects analysed
    42
    60
    Units: Percentage of subjects
        number (not applicable)
    33.3
    35
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ustekinumab
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9939
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 2.34

    Secondary: Change from Baseline in Number of Joints with Pain and Signs of Inflammation at Week 24

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    End point title
    		 Change from Baseline in Number of Joints with Pain and Signs of Inflammation at Week 24
    End point description
    Change from baseline in number of joints (active joint) with pain and signs of inflammation (tenderness, swelling or effusion) for subjects 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). FAS included all the randomized subjects who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Population included subjects with at least 2 affected joints at baseline (2 or more affected joints).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Placebo Ustekinumab
    Number of subjects analysed
    31
    51
    Units: Joints
        arithmetic mean (standard deviation)
    -2.8 ( 7.31 )
    -4.5 ( 4.42 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ustekinumab
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1032
    Method
    		 Mixed model repeated measures model
    Parameter type
    		 LS Means Difference
    Point estimate
    -2.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.78
         upper limit
    		 0.45

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to Week 120
    Adverse event reporting additional description
    Safety analysis set was defined as the set of all randomized subjects who have received at least 1 dose (partial or complete, intravenously [IV] or subcutaneously [SC]) of ustekinumab or placebo.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo (Up to Week 24)
    Reporting group description
    		 Subjects received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.

    Reporting group title
    Ustekinumab (Up to Week 24)
    Reporting group description
    		 Subjects 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.

    Reporting group title
    Placebo to Ustekinumab (Week 24 to 56)
    Reporting group description
    		 Subjects 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.

    Reporting group title
    Ustekinumab (Week 24 to 56)
    Reporting group description
    		 Subjects who were assigned to Ustekinumab treatment and who completed placebo controlled period (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.

    Reporting group title
    Placebo to Ustekinumab (Week 56 to 120)
    Reporting group description
    		 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 subjects followed by safety follow-up through Week 120.

    Reporting group title
    Ustekinumab (Week 56 to 120)
    Reporting group description
    		 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 subjects followed by safety follow-up through Week 120.

    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)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 42 (9.52%)
    5 / 60 (8.33%)
    5 / 33 (15.15%)
    7 / 56 (12.50%)
    1 / 17 (5.88%)
    4 / 29 (13.79%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Keratoacanthoma
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus Fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Raynaud's Phenomenon
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary Artery Occlusion
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic Stroke
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 60 (1.67%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Posterior Reversible Encephalopathy Syndrome
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Hypochromic Anaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 60 (1.67%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric Ulcer
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 60 (1.67%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus Nephritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic Lupus Erythematosus
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 60 (1.67%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic Sepsis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 60 (1.67%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salmonella Sepsis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stenotrophomonas Infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-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)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 42 (59.52%)
    30 / 60 (50.00%)
    21 / 33 (63.64%)
    34 / 56 (60.71%)
    8 / 17 (47.06%)
    22 / 29 (75.86%)
    Vascular disorders
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 60 (5.00%)
    0 / 33 (0.00%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    0
    2
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 60 (3.33%)
    2 / 33 (6.06%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    3
    1
    0
    0
    Reproductive system and breast disorders
    Menstruation Irregular
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Ovarian Cyst
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    2 / 33 (6.06%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    2
    1
    0
    1
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 60 (1.67%)
    1 / 33 (3.03%)
    2 / 56 (3.57%)
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    3
    2
    2
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 60 (3.33%)
    1 / 33 (3.03%)
    1 / 56 (1.79%)
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    3
    4
    1
    2
    1
    Injury, poisoning and procedural complications
    Limb Injury
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 42 (11.90%)
    4 / 60 (6.67%)
    1 / 33 (3.03%)
    3 / 56 (5.36%)
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    5
    4
    1
    3
    0
    2
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 60 (0.00%)
    2 / 33 (6.06%)
    4 / 56 (7.14%)
    1 / 17 (5.88%)
    4 / 29 (13.79%)
         occurrences all number
    4
    0
    4
    10
    1
    7
    Neutropenia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 60 (1.67%)
    2 / 33 (6.06%)
    3 / 56 (5.36%)
    1 / 17 (5.88%)
    3 / 29 (10.34%)
         occurrences all number
    3
    1
    4
    8
    1
    6
    Anaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    2 / 33 (6.06%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    2
    1
    0
    1
    Eye disorders
    Dry Eye
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    2 / 33 (6.06%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    2
    1
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 42 (0.00%)
    4 / 60 (6.67%)
    3 / 33 (9.09%)
    3 / 56 (5.36%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    5
    3
    3
    0
    0
    Nausea
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 60 (5.00%)
    1 / 33 (3.03%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    3
    1
    1
    0
    0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Actinic Keratosis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    0
    Skin Lesion
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    1 / 56 (1.79%)
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    1
    2
    1
    2
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    2 / 56 (3.57%)
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    0
    2
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Back Pain
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 60 (3.33%)
    0 / 33 (0.00%)
    5 / 56 (8.93%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    2
    2
    0
    6
    0
    1
    Systemic Lupus Erythematosus
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 60 (5.00%)
    2 / 33 (6.06%)
    2 / 56 (3.57%)
    1 / 17 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    2
    3
    3
    2
    2
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 60 (3.33%)
    1 / 33 (3.03%)
    4 / 56 (7.14%)
    0 / 17 (0.00%)
    4 / 29 (13.79%)
         occurrences all number
    0
    2
    1
    4
    0
    4
    Gastroenteritis
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 60 (1.67%)
    3 / 33 (9.09%)
    0 / 56 (0.00%)
    2 / 17 (11.76%)
    0 / 29 (0.00%)
         occurrences all number
    2
    1
    3
    0
    2
    0
    Gastroenteritis Viral
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 42 (7.14%)
    6 / 60 (10.00%)
    2 / 33 (6.06%)
    6 / 56 (10.71%)
    1 / 17 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    3
    7
    4
    7
    2
    3
    Pharyngitis
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 60 (5.00%)
    1 / 33 (3.03%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    1
    2
    0
    1
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 60 (5.00%)
    0 / 33 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Tooth Abscess
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 60 (1.67%)
    1 / 33 (3.03%)
    3 / 56 (5.36%)
    0 / 17 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    1
    1
    3
    0
    3
    Upper Respiratory Tract Infection
         subjects affected / exposed
    9 / 42 (21.43%)
    5 / 60 (8.33%)
    3 / 33 (9.09%)
    10 / 56 (17.86%)
    1 / 17 (5.88%)
    3 / 29 (10.34%)
         occurrences all number
    9
    6
    4
    17
    1
    6
    Urinary Tract Infection
         subjects affected / exposed
    4 / 42 (9.52%)
    6 / 60 (10.00%)
    6 / 33 (18.18%)
    10 / 56 (17.86%)
    2 / 17 (11.76%)
    6 / 29 (20.69%)
         occurrences all number
    4
    6
    10
    17
    3
    7
    Infected Bite
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    0 / 33 (0.00%)
    2 / 56 (3.57%)
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Tinea Versicolour
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Tooth Infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 60 (1.67%)
    2 / 33 (6.06%)
    1 / 56 (1.79%)
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    2
    1
    0
    1
    Vulvitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 60 (0.00%)
    1 / 33 (3.03%)
    0 / 56 (0.00%)
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2015
    Overall reason for this amendment was to clarify the use of highly effective methods of contraception for subject inclusion and continuation in the study, and correction of minor errors and omissions.
    24 Nov 2015
    Overall reasons for this amendment was to provide clarification regarding 1) subject eligibility and enrollment, 2) use of restricted and prohibited concomitant medications, 3) refine the definition of primary endpoint, 4) specify conditions under which subjects may undergo retesting at screening, 5) elaborate on statistical procedures to be used to conduct interim and planned data analyses, and 6) provide additional information regarding collection of samples.
    18 Jan 2017
    Overall reason for this amendment was to further evaluate the safety and efficacy of long-term ustekinumab administration in subjects with Systemic Lupus Erythematosus (SLE) who participated in CNTO1275SLE2001 study extension.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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