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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2010-022759-42
    Trial protocol
    DE   GB   ES   NL   HU   IS   BG   IT  
    Global end of trial date
    28 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    25 May 2016
    First version publication date
    25 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1275CRD3002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01369342
    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
    Janssen Research & Development, LLC , Clinical Registry Group, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen Research & Development, LLC , Clinical Registry Group, 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
    28 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to evaluate the efficacy of Intravenous (IV) induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn’s disease who have demonstrated an inadequate response to or have failed to tolerate corticosteroids or immunomodulators: 6-mercaptopurine (6-MP), azathioprine (AZA), methotrexate (MTX), and to evaluate the safety of IV induction regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease.
    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 was evaluated based on Adverse events (AEs) and clinical laboratory test results (including hematology and serum chemistry), Physical examinations and 12 Lead Electrocardiograms (ECGs).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jun 2011
    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
    South Africa: 33
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    United States: 220
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Brazil: 9
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Canada: 42
    Country: Number of subjects enrolled
    Croatia: 4
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 47
    Country: Number of subjects enrolled
    Hungary: 61
    Country: Number of subjects enrolled
    Iceland: 2
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Japan: 26
    Country: Number of subjects enrolled
    Korea, Republic of: 20
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    New Zealand: 14
    Country: Number of subjects enrolled
    Poland: 26
    Country: Number of subjects enrolled
    Russian Federation: 17
    Country: Number of subjects enrolled
    Serbia: 15
    Worldwide total number of subjects
    640
    EEA total number of subjects
    213
    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)
    611
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at multiple sites in North America, South America, Eastern Europe, Western Europe, the Asia-Pacific region, and South Africa that evaluated ustekinumab in subjects with Crohn’s disease.

    Pre-assignment
    Screening details
    A total of 640 subjects were randomized in the study. Out of which, 214 in the placebo group, 213 in the ustekinumab 130 milligram (mg) group, and 213 in the ustekinumab 6 milligram per kilogram (mg/kg) group.

    Period 1
    Period 1 title
    Overall Study (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
    Placebo
    Arm description
    All subjects randomized to single Intravenous (IV) dose of placebo at Week 0.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    All subjects were to receive single Intravenous (IV) dose of placebo at Week 0.

    Arm title
    Ustekinumab 130 milligram (mg)
    Arm description
    Subjects randomized to 130 milligram of Ustekinumab given intravenously at week 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to receive to 130 milligram of Ustekinumab given intravenously at week 0.

    Arm title
    Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Arm description
    Subjects randomized to weight-range ustekinumab approximately (~) 6 mg/kg: 260 mg (weight less than or equal to (<=) 55 kg) 390 mg (weight more than (>) 55 kg and below or equivivalent to (<=) 85 kg) and 520 mg (weight more than (>) 85 kg).
    Arm type
    Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to receive Ustekinumab ~ 6 mg/kg administered intravenously at week 0.

    Number of subjects in period 1
    Placebo Ustekinumab 130 milligram (mg) Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Started
    214
    213
    213
    Completed
    201
    204
    210
    Not completed
    13
    9
    3
         Other
    1
    -
    -
         Consent withdrawn by subject
    7
    7
    2
         Lost to follow-up
    5
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    All subjects randomized to single Intravenous (IV) dose of placebo at Week 0.

    Reporting group title
    Ustekinumab 130 milligram (mg)
    Reporting group description
    Subjects randomized to 130 milligram of Ustekinumab given intravenously at week 0.

    Reporting group title
    Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Reporting group description
    Subjects randomized to weight-range ustekinumab approximately (~) 6 mg/kg: 260 mg (weight less than or equal to (<=) 55 kg) 390 mg (weight more than (>) 55 kg and below or equivivalent to (<=) 85 kg) and 520 mg (weight more than (>) 85 kg).

    Reporting group values
    Placebo Ustekinumab 130 milligram (mg) Ustekinumab ~ 6 milligram per kilogram (mg/kg) Total
    Number of subjects
    214 213 213 640
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    204 203 204 611
        From 65 to 84 years
    10 10 9 29
        85 years and over
    0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    40.1 ± 13.09 39.2 ± 13.74 38.8 ± 13.65 -
    Title for Gender
    Units: subjects
        Female
    113 107 122 342
        Male
    101 106 91 298

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    All subjects randomized to single Intravenous (IV) dose of placebo at Week 0.

    Reporting group title
    Ustekinumab 130 milligram (mg)
    Reporting group description
    Subjects randomized to 130 milligram of Ustekinumab given intravenously at week 0.

    Reporting group title
    Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Reporting group description
    Subjects randomized to weight-range ustekinumab approximately (~) 6 mg/kg: 260 mg (weight less than or equal to (<=) 55 kg) 390 mg (weight more than (>) 55 kg and below or equivivalent to (<=) 85 kg) and 520 mg (weight more than (>) 85 kg).

    Primary: Number of subjects in Clinical Response at week 6

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    End point title
    Number of subjects in Clinical Response at week 6
    End point description
    Clinical response at Week 6 is defined as a reduction from baseline in the Crohn’s Disease Activity Index (CDAI) score of at least (>=) 100 points. Subjects with a baseline CDAI score of 220 to 248 points were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. Only subjects randomized after study re-start were included in the key efficacy analysis (please refer protocol amendment section).
    End point type
    Primary
    End point timeframe
    Week 6
    End point values
    Placebo Ustekinumab 130 milligram (mg) Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects analysed
    209
    209
    209
    Units: Number of Subjects
    60
    108
    116
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of ustekinumab treatment groups and placebo group using 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at significance level of 0.05. A fixed sequence testing procedure was used to control the Type I error at the 0.05 level over the primary and major secondary endpoints described herein.
    Comparison groups
    Placebo v Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab 130 milligram (mg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval

    Secondary: Number of Subjects in Clinical Remission at week 8

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    End point title
    Number of Subjects in Clinical Remission at week 8
    End point description
    Clinical remission at Week 8 was defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points. Only subjects randomized after study re-start were included in the key efficacy analysis.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Placebo Ustekinumab 130 milligram (mg) Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects analysed
    209
    209
    209
    Units: Number of Subjects
    41
    64
    84
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (<=300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab 130 milligram (mg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval

    Secondary: Number of Subjects in Clinical response at week 8

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    End point title
    Number of Subjects in Clinical response at week 8
    End point description
    Clinical response at Week 8 is defined as a reduction from baseline in the Crohn’s Disease Activity Index (CDAI) score of more than or equal to (>=)100 points. Subjects with a baseline CDAI score of 220 to 248 points were considered to be in clinical response if a CDAI score of <150 was attained. Only subjects randomized after study re-start were included in the key efficacy analysis.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Placebo Ustekinumab 130 milligram (mg) Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects analysed
    209
    209
    209
    Units: Number of Subjects
    67
    99
    121
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab 130 milligram (mg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval

    Secondary: Number of Subjects in 70-point Response at Week 6

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    End point title
    Number of Subjects in 70-point Response at Week 6
    End point description
    The endpoint of 70-point response at Week 6 was defined as a reduction from baseline in the Crohn’s Disease Activity Index (CDAI) score of more than or equal to (>=) 70 points at Week 6. Only subjects randomized after study re-start were included in the key efficacy analysis.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    Placebo Ustekinumab 130 milligram (mg) Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects analysed
    209
    209
    209
    Units: Number of Subjects
    81
    123
    135
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab 130 milligram (mg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval

    Secondary: Number of subjects in 70-point Response at Week 3

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    End point title
    Number of subjects in 70-point Response at Week 3
    End point description
    The endpoint of 70-point response at Week 3 was defined as a reduction from baseline in the Crohn’s Disease Activity Index (CDAI) score of more than or equal to (>=) 70 points at Week 3.Only subjects randomized after study re-start were included in the key efficacy analysis
    End point type
    Secondary
    End point timeframe
    Week 3
    End point values
    Placebo Ustekinumab 130 milligram (mg) Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects analysed
    209
    209
    209
    Units: Number of Subjects
    66
    103
    106
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab ~ 6 milligram per kilogram (mg/kg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    The proportion of subjects was summarized and compared between each of the ustekinumab treatment groups and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (≤300 or >300), at a significance level of 0.05.
    Comparison groups
    Placebo v Ustekinumab 130 milligram (mg)
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to week 8
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    All subjects received single Intravenous (IV) dose of placebo at Week 0.

    Reporting group title
    Ustekinumab approximately (~) 6 mg/kg
    Reporting group description
    Subjects received weight-range ustekinumab ~ 6 mg/kg: 260 mg (weight less than or equal to (<=) 55 kg) 390 mg (weight more than (>) 55 kg and below or equivivalent to (<=) 85 kg) and 520 mg (weight more than (>) 85 kg).

    Reporting group title
    Ustekinumab 130 mg
    Reporting group description
    Subjects received 130 milligram of Ustekinumab given intravenously at week 0.

    Serious adverse events
    Placebo Ustekinumab approximately (~) 6 mg/kg Ustekinumab 130 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 212 (7.08%)
    9 / 211 (4.27%)
    10 / 216 (4.63%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Incisional Hernia
         subjects affected / exposed
    0 / 212 (0.00%)
    0 / 211 (0.00%)
    1 / 216 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax Spontaneous
         subjects affected / exposed
    0 / 212 (0.00%)
    1 / 211 (0.47%)
    1 / 216 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Granuloma
         subjects affected / exposed
    0 / 212 (0.00%)
    1 / 211 (0.47%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    1 / 216 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 212 (0.00%)
    1 / 211 (0.47%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired Healing
         subjects affected / exposed
    0 / 212 (0.00%)
    0 / 211 (0.00%)
    1 / 216 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 212 (0.00%)
    0 / 211 (0.00%)
    1 / 216 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 212 (0.00%)
    1 / 211 (0.47%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    5 / 212 (2.36%)
    2 / 211 (0.95%)
    5 / 216 (2.31%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 212 (0.00%)
    0 / 211 (0.00%)
    1 / 216 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised Intraabdominal Fluid Collection
         subjects affected / exposed
    0 / 212 (0.00%)
    0 / 211 (0.00%)
    1 / 216 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 212 (0.47%)
    2 / 211 (0.95%)
    1 / 216 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Perforation
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal Abscess
         subjects affected / exposed
    3 / 212 (1.42%)
    0 / 211 (0.00%)
    2 / 216 (0.93%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 212 (0.00%)
    1 / 211 (0.47%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Genital Herpes
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 212 (0.47%)
    0 / 211 (0.00%)
    0 / 216 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Ustekinumab approximately (~) 6 mg/kg Ustekinumab 130 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 212 (20.75%)
    44 / 211 (20.85%)
    40 / 216 (18.52%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 212 (6.60%)
    10 / 211 (4.74%)
    20 / 216 (9.26%)
         occurrences all number
    17
    16
    26
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    10 / 212 (4.72%)
    11 / 211 (5.21%)
    6 / 216 (2.78%)
         occurrences all number
    12
    11
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 212 (2.36%)
    11 / 211 (5.21%)
    7 / 216 (3.24%)
         occurrences all number
    5
    12
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 212 (4.72%)
    14 / 211 (6.64%)
    10 / 216 (4.63%)
         occurrences all number
    10
    14
    11
    Upper Respiratory Tract Infection
         subjects affected / exposed
    11 / 212 (5.19%)
    7 / 211 (3.32%)
    4 / 216 (1.85%)
         occurrences all number
    12
    7
    5

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2011
    The amendment includes the changes like; Sponsor temporarily suspended dosing of subjects with the proposed new formulation of ustekinumab in November 2011 because a stability issue was identified with the batch of the IV drug (130 milligram (mg) ustekinumab in 26 mL [5 milligram per milliliter (mg/mL)]) used in the study. To prevent significant delay to study CNTO1275CRD3002, the Sponsor substituted the new formulation (130 mg ustekinumab in 26 ml) with the approved 90 mg/mL ustekinumab formulation for the protocol-specified IV induction administrations. The 3 Phase 3 protocols were amended to incorporate the use of the 90 mg/mL formulation and the studies were completed, or are ongoing, with the 90 mg/mL formulation (supplied as 90 mg in 1 mL nominal volume and 45 mg in 0.5 mL nominal volume). Because knowledge of the stability issue could potentially bias the assessments, data from the 12 subjects who were randomized before the study was temporarily suspended were not used in the planned analyses. To maintain the originally planned sample size of 600 subjects, which was needed to power the primary endpoint analysis, the planned enrollment in the Statistical Analysis Plan (SAP) was prospectively changed to 612 (600+12) subjects
    03 Jun 2014
    The amendment included clarification on changes in the description of the prohibited medications and wording regarding the initiation or medication dosage change for Crohn’s disease-specific medications; clarification that discussion with the medical monitor regarding the use of a local or central laboratory for selected tests was appropriate; removal of the requirement for the IVRS/IWRS system to project the expected number of subjects in the primary analysis population of the maintenance study and possibly increase enrollment for this induction study; clarification of the internal procedures for determining which SAEs were appropriate for reporting.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    17 Nov 2011
    The global study was interrupted due to issues with the clinical supply.
    17 Feb 2012

    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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