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    Clinical Trial Results:
    A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease

    Summary
    EudraCT number
    2018-002629-51
    Trial protocol
    NL   ES   SE   FR   AT   GB   CZ   IT  
    Global end of trial date
    10 Jan 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Jan 2024
    First version publication date
    21 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1275CRD3008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03782376
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag Ltd.
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333 CM
    Public contact
    Clinical Registry Group, Janssen-Cilag Ltd., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag Ltd., 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
    10 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2023
    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 achievement of clinical response at Week 16 following a single intravenous (IV) re-induction dose of 6 milligrams per kilogram (mg/kg) ustekinumab, compared with continuing regular subcutaneous (SC) every 8 weeks (q8w) 90 mg ustekinumab administration, in subjects with secondary loss of response (LoR) to SC q8w 90 mg ustekinumab maintenance therapy.
    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.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 69
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Czechia: 5
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    United States: 67
    Worldwide total number of subjects
    215
    EEA total number of subjects
    121
    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)
    203
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 215 subjects were enrolled, of which 159 subjects completed the study.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group 1: Ustekinumab (IV Re-induction)
    Arm description
    Subjects who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 mg/kg as an intravenous IV infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all subjects received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all subjects underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Subjects were followed-up for safety up to Week 36.
    Arm type
    Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    STELARA
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received IV infusion of 6 mg/kg Ustekinumab at Week 0.

    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 SC maintenance injections of 90 mg ustekinumab at Weeks 8 and 16.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of placebo (matched to Ustekinumab) at Week 0.

    Arm title
    Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Arm description
    Subjects who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all subjects received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all subjects underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Subjects were followed-up for safety up to Week 36.
    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 SC maintenance injections of 90 mg ustekinumab at Weeks 0, 8, and 16.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received IV infusion of placebo (matched to Ustekinumab) at Week 0.

    Number of subjects in period 1
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Started
    108
    107
    Completed
    82
    77
    Not completed
    26
    30
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    7
    11
         Unspecified
    16
    17
         Lost to follow-up
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Ustekinumab (IV Re-induction)
    Reporting group description
    Subjects who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 mg/kg as an intravenous IV infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all subjects received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all subjects underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Subjects were followed-up for safety up to Week 36.

    Reporting group title
    Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Reporting group description
    Subjects who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all subjects received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all subjects underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Subjects were followed-up for safety up to Week 36.

    Reporting group values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance) Total
    Number of subjects
    108 107 215
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    102 101 203
        From 65 to 84 years
    6 6 12
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    41.8 ( 13.63 ) 40 ( 13.07 ) -
    Title for Gender
    Units: subjects
        Female
    62 62 124
        Male
    46 45 91

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Ustekinumab (IV Re-induction)
    Reporting group description
    Subjects who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 mg/kg as an intravenous IV infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all subjects received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all subjects underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Subjects were followed-up for safety up to Week 36.

    Reporting group title
    Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Reporting group description
    Subjects who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all subjects received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all subjects underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Subjects were followed-up for safety up to Week 36.

    Primary: Percentage of Subjects With Clinical Response at Week 16

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    End point title
    Percentage of Subjects With Clinical Response at Week 16
    End point description
    Clinical response: greater than or equal to (>=) 100-point reduction from baseline in Crohn’s disease activity index (CDAI) score or a CDAI score < 150 points. CDAI is a measure of severity of illness derived as weighted sum of 8 Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored on diary over 7 days by subjects. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Subjects with prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated of worsening CD prior to designated analysis timepoint were considered not in clinical response, regardless of their CDAI score. Full analysis set (FAS) included randomised subjects.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    49.1
    37.4
    Statistical analysis title
    Ustekinumab IV Vs Ustekinumab SC
    Statistical analysis description
    The fixed sequence testing method was used. Cochran-Mantel Haenszel (CMH)-chi-square test stratified by baseline CDAI score (<= 300 or > 300), and prior biologic failure status at baseline (yes or no).
    Comparison groups
    Group 1: Ustekinumab (IV Re-induction) v Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.089 [1]
    Method
    Cochran-Mantel Haenszel-chi-square test
    Parameter type
    Difference in percentage
    Point estimate
    11.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    24.5
    Notes
    [1] - Threshold for significance was 0.05 level.

    Secondary: Percentage of Subjects With Clinical Response at Week 8

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    End point title
    Percentage of Subjects With Clinical Response at Week 8
    End point description
    Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a measure of severity of illness derived as a weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the subject on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Subjects who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. FAS included all randomised subjects.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    51.9
    44.9
    Statistical analysis title
    Ustekinumab IV Vs Ustekinumab SC
    Statistical analysis description
    The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (<= 300 or > 300), and prior biologic failure status at baseline (yes or no).
    Comparison groups
    Group 1: Ustekinumab (IV Re-induction) v Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3 [2]
    Method
    CMH chi-square test (2-sided)
    Parameter type
    Difference in percentage
    Point estimate
    7.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6
         upper limit
    20.2
    Notes
    [2] - Since the primary endpoint did not achieve statistical significance, all p-values for the major secondary endpoints are nominal and are not statistically significant.

    Secondary: Percentage of Subjects With Clinical Remission at Week 16

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    End point title
    Percentage of Subjects With Clinical Remission at Week 16
    End point description
    Percentage of subjects with clinical remission at Week 16 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by subject on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Subjects who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. FAS included all randomised subjects.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    33.3
    27.1
    Statistical analysis title
    Ustekinumab IV Vs Ustekinumab SC
    Statistical analysis description
    The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (<= 300 or > 300), and prior biologic failure status at baseline (yes or no).
    Comparison groups
    Group 1: Ustekinumab (IV Re-induction) v Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.338 [3]
    Method
    CMH chi-square test (2-sided)
    Parameter type
    Difference in percentage
    Point estimate
    5.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6
         upper limit
    17.8
    Notes
    [3] - Since the primary endpoint did not achieve statistical significance, all p-values for the major secondary endpoints are nominal and are not statistically significant.

    Secondary: Percentage of Subjects with Normalisation of C-reactive Protein (CRP) and/or Normalisation of Fecal Calprotectin (fCal) Concentration at Week 16

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    End point title
    Percentage of Subjects with Normalisation of C-reactive Protein (CRP) and/or Normalisation of Fecal Calprotectin (fCal) Concentration at Week 16
    End point description
    Percentage of subjects with normalisation at Week 16, among subjects with elevated CRP and/or fCal at baseline were reported. Subjects were considered normalised if at least one biomarker (fCal or CRP) was normalised. Normalised CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalised fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or fCal value was abnormal at baseline and value of same parameter normalises at analysis time, subjects were considered normalised at designated analysis timepoint. Subjects with prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued drug due to lack of efficacy or adverse event indicated of worsening CD prior to analysis time are considered not normalised. Subjects with insufficient data at analysis timepoint had last value carried forward. FAS included all randomised subjects with either elevated CRP and/or elevated fCal at baseline.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    93
    94
    Units: Percentage of subjects
        number (not applicable)
    33.3
    14.9
    Statistical analysis title
    Ustekinumab IV Vs Ustekinumab SC
    Statistical analysis description
    The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (<= 300 or > 300), and prior biologic failure status at baseline (yes or no).
    Comparison groups
    Group 1: Ustekinumab (IV Re-induction) v Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004 [4]
    Method
    CMH chi-square test (2-sided)
    Parameter type
    Difference in percentage
    Point estimate
    18.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.8
         upper limit
    30.2
    Notes
    [4] - Since the primary endpoint did not achieve statistical significance, all p-values for the major secondary endpoints are nominal and are not statistically significant.

    Secondary: Percentage of Subjects With Clinical Remission at Week 8

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    End point title
    Percentage of Subjects With Clinical Remission at Week 8
    End point description
    Percentage of subjects with clinical remission at Week 8 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by subject on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Subjects who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of effi cacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. FAS included all randomised subjects.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    35.2
    29.0
    Statistical analysis title
    Ustekinumab IV Vs Ustekinumab SC
    Statistical analysis description
    The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (<= 300 or > 300), and prior biologic failure status at baseline (yes or no).
    Comparison groups
    Group 1: Ustekinumab (IV Re-induction) v Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.314 [5]
    Method
    CMH chi-square test (2-sided)
    Parameter type
    Difference in percentage
    Point estimate
    6.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.8
         upper limit
    18.6
    Notes
    [5] - Since the primary endpoint did not achieve statistical significance, all p-values for the major secondary endpoints are nominal and are not statistically significant.

    Secondary: Percentage of Subjects With Clinical Remission at Week 24

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    End point title
    Percentage of Subjects With Clinical Remission at Week 24
    End point description
    Percentage of subjects with clinical remission at Week 24 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by subject on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Subjects who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. FAS included all randomised subjects.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    37.0
    27.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinical Response at Week 24

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    End point title
    Percentage of Subjects With Clinical Response at Week 24
    End point description
    Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the subject on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Subjects who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. FAS included all randomised subjects.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    47.2
    39.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Normalisation of C-reactive Protein (CRP) and/or Normalisation of Fecal Calprotectin (fCal) Concentration at Week 24

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    End point title
    Percentage of Subjects with Normalisation of C-reactive Protein (CRP) and/or Normalisation of Fecal Calprotectin (fCal) Concentration at Week 24
    End point description
    Percentage of subjects with normalisation at Week 24, among subjects with elevated CRP and/or fCal at baseline were reported. Subjects were considered normalised if at least one biomarker (fCal or CRP) was normalised. Normalised CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalised fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or fCal value was abnormal at baseline and value of same parameter normalises at analysis time, subjects were considered normalised at designated analysis timepoint. Subjects with prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued drug due to lack of efficacy or adverse event indicated of worsening CD prior to analysis time are considered not normalised. Subjects with insufficient data at analysis timepoint had last value carried forward. FAS included all randomised subjects with either elevated CRP and/or elevated fCal at baseline.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    93
    94
    Units: Percentage of subjects
        number (not applicable)
    26.9
    21.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Adverse Events (TEAEs)

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    End point title
    Percentage of Subjects with Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event was any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this endpoint, TEAEs including all AEs irrespective of being serious or non-serious AE are reported. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From baseline (Week 0) up to Week 36
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    70.4
    72.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    Percentage of Subjects with Treatment-emergent Serious Adverse Events (TESAEs)
    End point description
    A serious adverse event (SAE) was an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From baseline (Week 0) up to Week 36
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    8.3
    12.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Infections

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    End point title
    Percentage of Subjects with Treatment-emergent Infections
    End point description
    Percentage of subjects with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From baseline (Week 0) up to Week 36
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    33.3
    29.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Serious Infections

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    End point title
    Percentage of Subjects with Treatment-emergent Serious Infections
    End point description
    Percentage of subjects with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From baseline (Week 0) up to Week 36
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    108
    107
    Units: Percentage of subjects
        number (not applicable)
    1.9
    1.9
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)

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    End point title
    Change from Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)
    End point description
    Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' signifies subjects who were evaluated at specified timepoints for specified parameters.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16, 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    103
    98
    Units: Grams per liter (g/L)
    arithmetic mean (standard deviation)
        Week 8: Hematology (Hemoglobin) (n=103, 92)
    2.893 ( 9.5568 )
    -0.185 ( 7.8669 )
        Week 16: Hematology (Hemoglobin) (n=94,85)
    3.245 ( 10.4621 )
    0.835 ( 10.4652 )
        Week 24: Hematology (Hemoglobin) (n=74,75)
    3.203 ( 11.2408 )
    -0.400 ( 11.2610 )
        Week 8: Chemistry (Albumin) (n=102,98)
    0.765 ( 2.9456 )
    0.286 ( 2.6671 )
        Week 16: Chemistry (Albumin) (n=97,92)
    0.567 ( 3.0649 )
    0.554 ( 3.3753 )
        Week 24: Chemistry (Albumin) (n=81,77)
    0.741 ( 2.9613 )
    0.221 ( 3.1690 )
        Week 8: Chemistry (Total protein) (n=102,98)
    0.588 ( 4.6806 )
    0.265 ( 4.3803 )
        Week 16: Chemistry (Total protein) (n=97,92)
    0.340 ( 5.2418 )
    0.783 ( 4.7690 )
        Week 24: Chemistry (Total protein) (n=81,78)
    0.605 ( 4.4150 )
    0.333 ( 5.4954 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Laboratory Values for Hematology (Hematocrit)

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    End point title
    Change from Baseline in Clinical Laboratory Values for Hematology (Hematocrit)
    End point description
    Change from baseline in clinical laboratory values for hematology (hematocrit) was reported. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' signifies subjects who were evaluated at specified timepoints
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16, 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    101
    88
    Units: Percentage of red blood cells
    arithmetic mean (standard deviation)
        Week 8 (n=101,88)
    0.009 ( 0.0313 )
    -0.001 ( 0.277 )
        Week 16 (n=90,83)
    0.010 ( 0.0306 )
    0.001 ( 0.0356 )
        Week 24 (n=74,71)
    0.009 ( 0.0358 )
    0.001 ( 0.0349 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Laboratory values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)

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    End point title
    Change from Baseline in Clinical Laboratory values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)
    End point description
    Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' signifies subjects who were evaluated at specified timepoints for specific parameters
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16, 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    103
    92
    Units: 10^9 cells/L
    arithmetic mean (standard deviation)
        Week 8: Total WBC (n=103,92)
    -0.386 ( 1.8358 )
    -0.272 ( 1.7301 )
        Week 16: Total WBC (n=94,85)
    -0.329 ( 2.2700 )
    -0.124 ( 2.1404 )
        Week 24: Total WBC (n=74,75)
    -0.149 ( 2.2347 )
    0.104 ( 1.6612 )
        Week 8:Neutrophils (n=103, 92)
    -0.235 ( 1.7610 )
    -0.241 ( 1.6154 )
        Week 16: Neutrophils (n=94,85)
    -0.195 ( 2.0172 )
    -0.053 ( 2.1811 )
        Week 24: Neutrophils (n=74,75)
    -0.038 ( 2.2944 )
    0.133 ( 1.4312 )
        Week 8: Absolute Lymphocytes (n=103,92)
    -0.101 ( 0.4962 )
    -0.020 ( 0.3415 )
        Week 16: Absolute Lymphocytes (n=94,85)
    -0.088 ( 0.5690 )
    -0.052 ( 0.3997 )
        Week 24: Absolute Lymphocytes (n=74,75)
    -0.088 ( 0.6599 )
    -0.021 ( 0.3960 )
        Week 8: Eosinophils (n=103,92)
    -0.009 ( 0.0876 )
    -0.004 ( 0.1153 )
        Week 16: Eosinophils (n=94,85)
    -0.014 ( 0.1176 )
    -0.013 ( 0.1330 )
        Week 24: Eosinophils (n=74,75)
    -0.001 ( 0.0912 )
    -0.008 ( 0.1136 )
        Week 8: Platelets (n=103,92)
    -13.65 ( 56.553 )
    -0.67 ( 51.591 )
        Week 16: Platelets (n=93,85)
    -13.28 ( 60.105 )
    4.53 ( 60.785 )
        Week 24: Platelets (n=73,73)
    -10.89 ( 62.671 )
    -0.53 ( 56.624 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Laboratory values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])

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    End point title
    Change from Baseline in Clinical Laboratory values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])
    End point description
    Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' signifies subjects who were evaluated at specified timepoints for specified parameters.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16, 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    102
    98
    Units: Units per Liter (U/L)
    arithmetic mean (standard deviation)
        Week 8: Alkaline Phosphatase (n=102,98)
    -1.343 ( 10.7404 )
    -0.582 ( 10.3565 )
        Week 16: Alkaline Phosphatase (n=97,91)
    -0.072 ( 12.9488 )
    0.923 ( 11.5154 )
        Week 24: Alkaline Phosphatase (n=81,77)
    -0.296 ( 14.2649 )
    0.078 ( 16.1594 )
        Week 8: ALT (n=101,97)
    -0.347 ( 9.3642 )
    -0.412 ( 7.9001 )
        Week 16: ALT (n=95,89)
    -0.811 ( 8.3898 )
    -0.101 ( 9.9750 )
        Week 24: ALT (n=80,76)
    0.463 ( 10.1470 )
    2.224 ( 15.5979 )
        Week 8: AST (n=101,97)
    -0.525 ( 12.0147 )
    0.144 ( 4.8584 )
        Week 16: AST (n=96,92)
    -0.208 ( 12.6366 )
    0.163 ( 5.4557 )
        Week 24: AST (n=81,77)
    0.741 ( 5.6718 )
    1.519 ( 7.3047 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Laboratory values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)

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    End point title
    Change from Baseline in Clinical Laboratory values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)
    End point description
    Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' signifies subjects who were evaluated at specified timepoints for specified parameters.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16, 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    102
    98
    Units: micromole per liter (mcmol/L)
    arithmetic mean (standard deviation)
        Week 8: Total Bilirubin (n=101,97)
    0.639 ( 2.5303 )
    -0.131 ( 2.9617 )
        Week 16: Total Bilirubin (n=97,92)
    1.476 ( 3.4135 )
    0.555 ( 3.6679 )
        Week 24: Total Bilirubin (n=81,77)
    0.687 ( 3.0396 )
    0.254 ( 3.1664 )
        Week 8: Direct Bilirubin (n=100,97)
    0.086 ( 0.5495 )
    -0.010 ( 0.5998 )
        Week 16: Direct Bilirubin (n=92,90)
    0.154 ( 0.6910 )
    0.071 ( 0.7628 )
        Week 24: Direct Bilirubin (n=80,76)
    0.109 ( 0.5393 )
    0.009 ( 0.7612 )
        Week 8: Creatinine (n=102,98)
    -0.446 ( 8.9118 )
    -0.308 ( 9.6489 )
        Week 16: Creatinine (n=97,92)
    0.624 ( 9.7987 )
    1.117 ( 9.0316 )
        Week 24: Creatinine (n=81,77)
    1.717 ( 9.5267 )
    0.336 ( 8.4020 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/urea, Calcium, Phosphate)

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    End point title
    Change from Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/urea, Calcium, Phosphate)
    End point description
    Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported. Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjects were analysed according to the actual treatment received. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' signifies subjects who were evaluated at specified timepoints for specified parameters.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16, 24
    End point values
    Group 1: Ustekinumab (IV Re-induction) Group 2: Ustekinumab (Continuous q8w SC Maintenance)
    Number of subjects analysed
    102
    98
    Units: millimoles per liter (mmol/L)
    arithmetic mean (standard deviation)
        Sodium: Week 8 (n=102,98)
    0.108 ( 2.5714 )
    -0.061 ( 2.2375 )
        Sodium: Week 16 (n=97,92)
    -0.165 ( 2.2299 )
    0.011 ( 2.3370 )
        Sodium: Week 24 (n=81,77)
    0.235 ( 2.2928 )
    -0.117 ( 2.0454 )
        Potassium: Week 8 (n=101,98)
    0.126 ( 0.3596 )
    0.050 ( 0.3269 )
        Potassium: Week 16 (n=97,92)
    0.105 ( 0.3745 )
    -0.002 ( 0.3933 )
        Potassium: Week 24 (n=81,77)
    0.067 ( 0.3732 )
    0.001 ( 0.3185 )
        Chloride: Week 8 (n=102,98)
    0.078 ( 2.9136 )
    -0.520 ( 2.4714 )
        Chloride: Week 16 (n=97,92)
    -0.299 ( 2.4798 )
    -0.489 ( 2.5398 )
        Chloride: Week 24 (n=81,77)
    0.160 ( 2.4107 )
    -0.481 ( 2.2160 )
        BUN/urea: Week 8 (n=102,98)
    0.279 ( 1.0050 )
    0.248 ( 1.0710 )
        BUN/urea: Week 16 (n=97,92)
    0.204 ( 1.2812 )
    0.029 ( 1.2841 )
        BUN/urea: Week 24 (n=81,77)
    0.304 ( 1.2031 )
    0.179 ( 1.0629 )
        Calcium: Week 8 (n=102,98)
    0.022 ( 0.0967 )
    0.013 ( 0.0968 )
        Calcium: Week 16 (n=97,92)
    0.007 ( 0.1010 )
    0.007 ( 0.1098 )
        Calcium: Week 24 (n=81,77)
    0.008 ( 0.1101 )
    0.004 ( 0.1109 )
        Phosphate: Week 8 (n=102,98)
    0.005 ( 0.2015 )
    0.046 ( 0.2024 )
        Phosphate: Week 16 (n=97,92)
    0.006 ( 0.1946 )
    0.026 ( 0.1905 )
        Phosphate: Week 24 (n=81,77)
    0.018 ( 0.1612 )
    0.021 ( 0.1938 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (Week 0) up to Week 36
    Adverse event reporting additional description
    Safety analysis set included all randomised subjects who received at least 1 administration of study agent. Subjectss were analysed according to the actual treatment received.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Group 2: Ustekinumab (Continuous q8w SC maintenance)
    Reporting group description
    Subjects who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injfusion at Week 0. At Weeks 8 and 16, all subjects received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all subjects underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Subjects were followed-up for safety up to Week 36.

    Reporting group title
    Group 1: Ustekinumab (IV re-induction)
    Reporting group description
    Subjects who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all subjects received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all subjects underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Subjects were followed-up for safety up to Week 36.

    Serious adverse events
    Group 2: Ustekinumab (Continuous q8w SC maintenance) Group 1: Ustekinumab (IV re-induction)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 107 (12.15%)
    9 / 108 (8.33%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant Melanoma
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial Fibrillation
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    4 / 107 (3.74%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal Stenosis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Stenosis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus Urinary
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Atrophy
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Stenosis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Abscess
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Group 2: Ustekinumab (Continuous q8w SC maintenance) Group 1: Ustekinumab (IV re-induction)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 107 (71.96%)
    73 / 108 (67.59%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pituitary Tumour Benign
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Vascular disorders
    Superficial Vein Thrombosis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 108 (0.00%)
         occurrences all number
    3
    0
    Influenza Like Illness
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Injection Site Erythema
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    2
    1
    Injection Site Mass
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    4 / 107 (3.74%)
    2 / 108 (1.85%)
         occurrences all number
    6
    2
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Cystocele
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Heavy Menstrual Bleeding
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Pelvic Fluid Collection
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Scrotal Dermatitis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Female Genital Tract Fistula
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    6 / 107 (5.61%)
    1 / 108 (0.93%)
         occurrences all number
    6
    1
    Dyspnoea
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Dyspnoea Exertional
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    2
    Nasal Congestion
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Productive Cough
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Rhinitis Allergic
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Tonsillar Disorder
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Affective Disorder
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Conversion Disorder
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Insomnia
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Restlessness
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Investigations
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Blood Magnesium Decreased
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    C-Reactive Protein Increased
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Sars-Cov-2 Test Positive
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Vitamin D Decreased
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Weight Increased
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Foot Fracture
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Infusion Related Reaction
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Injection Related Reaction
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Ligament Rupture
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Procedural Pain
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Skin Laceration
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Spinal Compression Fracture
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Thermal Burn
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Vaccination Complication
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Tendon Rupture
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Nervous system disorders
    Carotid Arteriosclerosis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Dizziness Postural
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    5 / 107 (4.67%)
    8 / 108 (7.41%)
         occurrences all number
    7
    15
    Migraine
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Ophthalmic Migraine
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 107 (1.87%)
    3 / 108 (2.78%)
         occurrences all number
    2
    3
    Iron Deficiency Anaemia
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 108 (0.93%)
         occurrences all number
    2
    1
    Lymphopenia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Tinnitus
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Eye disorders
    Eye Irritation
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Photophobia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Uveitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Abdominal Pain
         subjects affected / exposed
    3 / 107 (2.80%)
    5 / 108 (4.63%)
         occurrences all number
    3
    6
    Abdominal Mass
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Abdominal Distension
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Food Poisoning
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Faecaloma
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Eosinophilic Oesophagitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Crohn's Disease
         subjects affected / exposed
    29 / 107 (27.10%)
    23 / 108 (21.30%)
         occurrences all number
    31
    23
    Constipation
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 108 (0.00%)
         occurrences all number
    3
    0
    Anal Skin Tags
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Anal Fistula
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Anal Fissure
         subjects affected / exposed
    4 / 107 (3.74%)
    0 / 108 (0.00%)
         occurrences all number
    4
    0
    Anal Eczema
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Abdominal Tenderness
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 107 (1.87%)
    2 / 108 (1.85%)
         occurrences all number
    2
    2
    Abdominal Pain Lower
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal Inflammation
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Large Intestine Polyp
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Haematochezia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    4 / 107 (3.74%)
    1 / 108 (0.93%)
         occurrences all number
    4
    1
    Rectal Haemorrhage
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Subileus
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 107 (1.87%)
    2 / 108 (1.85%)
         occurrences all number
    2
    2
    Proctalgia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Cholestasis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Acne
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Decubitus Ulcer
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Dermal Cyst
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Erythema Nodosum
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 108 (0.00%)
         occurrences all number
    3
    0
    Intertrigo
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Psoriasis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Urticaria
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Pelvi-Ureteric Obstruction
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    4 / 107 (3.74%)
    3 / 108 (2.78%)
         occurrences all number
    4
    3
    Back Pain
         subjects affected / exposed
    1 / 107 (0.93%)
    4 / 108 (3.70%)
         occurrences all number
    1
    4
    Greater Trochanteric Pain Syndrome
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Groin Pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Muscle Contracture
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Neck Pain
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Pain in Jaw
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Polyarthritis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Rheumatic Disorder
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Spondylitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Fistula
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Enteritis Infectious
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Abscess Soft Tissue
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Anal Abscess
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 108 (0.93%)
         occurrences all number
    2
    1
    Bronchitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Covid-19
         subjects affected / exposed
    16 / 107 (14.95%)
    12 / 108 (11.11%)
         occurrences all number
    16
    12
    Coronavirus Infection
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Clostridium Difficile Infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Erythema Migrans
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    4 / 107 (3.74%)
    2 / 108 (1.85%)
         occurrences all number
    4
    2
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Herpes Zoster
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Infected Fistula
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 107 (0.93%)
    4 / 108 (3.70%)
         occurrences all number
    1
    5
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 107 (4.67%)
    3 / 108 (2.78%)
         occurrences all number
    8
    5
    Otitis Externa
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis Streptococcal
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Pyelitis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Pyelonephritis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 107 (0.00%)
    5 / 108 (4.63%)
         occurrences all number
    0
    5
    Ureaplasma Infection
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    3 / 107 (2.80%)
    3 / 108 (2.78%)
         occurrences all number
    3
    3
    Vulvovaginal Candidiasis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Gout
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Iron Deficiency
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Vitamin D Deficiency
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Zinc Deficiency
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    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 Jul 2019
    The purpose of this amendment was to include information regarding the planned primary endpoint database lock at Week 16 and the final database lock. Other clarifications and changes were made to address investigator and site questions surrounding operational elements of the study.
    08 Apr 2020
    The purpose of this amendment was to allow for self-administration of subcutaneous study intervention at Weeks 8 and 16 outside a study site (eg, at home), in cases where a study site visit is not possible under restrictions and limitations during the Coronavirus Disease-2019 (COVID-19) pandemic. Guidance on other aspects of study conduct during the COVID-19 pandemic is also included.
    19 May 2020
    The purpose of this amendment was to allow subcutaneous injections of study intervention at Week 8 and Week 16 to be self-administered outside a study site, in cases where a site visit is not possible.
    05 Aug 2020
    The purpose of this amendment was to increase enrollment into the study, through allowing subjects who have previously received a dose interval shortening of 90mg SC ustekinumab less than every 8 weeks and clarify ileocolonoscopy as an exploratory endpoint for subjects who agree to this procedure.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    26 Mar 2020
    Enrollment was temporarily held early in the COVID-19 pandemic.
    01 Jul 2020

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Some exploratory endpoints including endoscopic assessments for baseline and week 16 and clinical data for 24 weeks are not reported in this summary and will be included in the manuscript.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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