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    Clinical Trial Results:
    A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

    Summary
    EudraCT number
    		 2013-004497-10
    Trial protocol
    		 BE   HU   GB   IT   ES   RO   DK   NL  
    Global end of trial date
    15 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Mar 2018
    First version publication date
    02 Mar 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CT-P13 3.4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02096861
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Celltrion, Inc.
    Sponsor organisation address
    23 Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of, 22014
    Public contact
    Clinical Operations Management Department, CELLTRION, Inc., +82 328506724, SuEun.Song@celltrion.com
    Scientific contact
    Clinical Planning Department, CELLTRION, Inc., +82 328506532, SungYoung.Lee@celltrion.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
    08 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that CT-P13 (Remsima) is non-inferior to Remicade at Week 6 (Dose 3), in terms of efficacy, as determined by the CDAI-70 response rate
    Protection of trial subjects
    Additional vital signs including blood pressure, heart and respiratory rates, and temperature were measured to monitor for possible hypersensitivity reactions on each dosing day and recorded at the following time points: • 15 minutes (± 5 minutes) before the beginning of the study drug infusion • At the start of the study drug infusion (± 5 minutes) • Every 30 minutes (± 5 minutes) after the start of the study drug infusion • At the end of the study drug infusion (± 5 minutes) and 30, 60, and 120 minutes (± 10 minutes) after the end of the study drug infusion In addition, hypersensitivity wasmonitored by routine continuous clinical monitoring, which had to be performed after the patient had rested quietly for at least 5 minutes in the supine position. Emergency equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial ventilator, had to be available. For patients who experienced or developed life-threatening infusion-related anaphylactic reactions, study drug was stopped immediately and the patient withdrawn from the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2014
    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
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Romania: 8
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Russian Federation: 50
    Country: Number of subjects enrolled
    Korea, Republic of: 54
    Country: Number of subjects enrolled
    Ukraine: 32
    Country: Number of subjects enrolled
    Israel: 26
    Country: Number of subjects enrolled
    United States: 3
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Mexico: 4
    Worldwide total number of subjects
    220
    EEA total number of subjects
    49
    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)
    216
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient randomly assigned to treatment: 19 September 2014 A total of 99 study centers were initiated in 4 geographical regions (Europe, North America, Latin America, and Asia Pacific)

    Pre-assignment
    Screening details
    		 Key Inclusion Criteria 1. Patient is male or female between 18 to 75 years old, inclusive 2. Patient has a diagnosis of CD according to CDAI 220 - 450 points for least 12 weeks prior to randomisation 3. Patient has not responded despite a full and adequate therapy/intolerant/has contraindications with corticosteroid and/or immunosuppressant

    Pre-assignment period milestones
    Number of subjects started
    		 308 [1]
    Intermediate milestone: Number of subjects
    Subject screened: 308
    Intermediate milestone: Number of subjects
    Enrolled: 220
    Number of subjects completed
    		 220

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening Failure: 88
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The 'Number of subjects reported to have started the pre-assignment period' means subjects who consented to participate in this trial through the Screening procedure. If these subjects meet Inclusion and Exclusion criteria defined by the protocol, they can be randomized which will have study drug administration.
    Period 1
    Period 1 title
    Before switching
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Data analyst became unblinded at Week 6 for reporting purpose. Other members were remained blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P13
    Arm description
    		 Patients who were randomized to CT-P13-CT-P13 or CT-P13-Remicade treatment groups at Week0
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Remsima, Inflectra
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

    Arm title
    		 Remicade
    Arm description
    		 Patients who were randomized to Remicade-Remicade or Remicade-CT-P13 treatment groups at Week0
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Remicade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

    Number of subjects in period 1
    		CT-P13 Remicade
    Started
    111
    109
    Completed
    92
    88
    Not completed
    19
    21
         Non-responder at Week 14
    9
    8
         PATIENT NON COMPLIENCE
    1
    -
         Consent withdrawn by subject
    -
    1
         Physician decision
    -
    1
         Disease progression
    2
    4
         Adverse event, non-fatal
    4
    6
         Lost to follow-up
    1
    -
         Protocol deviation
    2
    1
    Period 2
    Period 2 title
    After switching
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P13 - CT-P13
    Arm description
    		 CT-P13 followed by CT-P13 from Week 30
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Remsima, Inflectra
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

    Arm title
    		 CT-P13 - Remicade
    Arm description
    		 CT-P13 followed by Remicade from Week 30
    Arm type
    		 Experimental

    Investigational medicinal product name
    Remicade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

    Arm title
    		 Remicade - Remicade
    Arm description
    		 Remicade followed by Remicade from Week 30
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Remicade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

    Arm title
    		 Remicade - CT-P13
    Arm description
    		 Remicade followed by CT-P13 from Week 30
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Remsima, Inflectra
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

    Number of subjects in period 2
    		CT-P13 - CT-P13 CT-P13 - Remicade Remicade - Remicade Remicade - CT-P13
    Started
    48
    44
    41
    47
    Completed
    44
    40
    37
    45
    Not completed
    4
    4
    4
    2
         Consent withdrawn by subject
    -
    1
    -
    -
         Disease progression
    1
    2
    1
    -
         PATIENT WENT ABROAD SO ESV WAS NOT DONE
    -
    1
    -
    -
         Pregnancy
    -
    -
    1
    -
         Lost to follow-up
    2
    -
    2
    2
         Protocol deviation
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P13
    Reporting group description
    		 Patients who were randomized to CT-P13-CT-P13 or CT-P13-Remicade treatment groups at Week0

    Reporting group title
    Remicade
    Reporting group description
    		 Patients who were randomized to Remicade-Remicade or Remicade-CT-P13 treatment groups at Week0

    Reporting group values
    		 CT-P13 Remicade Total
    Number of subjects
    		 111 109 220
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 108 108 216
        From 65-84 years
    		 3 1 4
    Age continuous
    Units: years
        median (full range (min-max))
    		 35 (18 to 69) 32 (18 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 48 49 97
        Male
    		 63 60 123
    Subject analysis sets

    Subject analysis set title
    CT-P13 - CT-P13
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The number of patients who randomized to CT-P13-CT-P13 treatment group at Week 0. CT-P13 followed by CT-P13 from Week 30

    Subject analysis set title
    CT-P13 - Remicade
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The number of patients who randomized to CT-P13-Remicade treatment group at Week 0. CT-P13 followed by Remicade from Week 30

    Subject analysis set title
    Remicade - Remicade
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The number of patients who randomized to Remicade-Remicade treatment group at Week 0. Remicade followed by Remicade from Week 30

    Subject analysis set title
    Remicade - CT-P13
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The number of patients who randomized to Remicade-CT-P13 treatment group at Week 0. Remicade followed by CT-P13 from Week 30

    Subject analysis sets values
    		 CT-P13 - CT-P13 CT-P13 - Remicade Remicade - Remicade Remicade - CT-P13
    Number of subjects
    56
    55
    54
    55
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    54
    54
    53
    55
        From 65-84 years
    2
    1
    1
    0
    Age continuous
    Units: years
        median (full range (min-max))
    39 (19 to 68)
    31 (18 to 69)
    31 (18 to 69)
    35 (19 to 63)
    Gender categorical
    Units: Subjects
        Female
    27
    21
    28
    21
        Male
    29
    34
    26
    34

    End points

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    End points reporting groups
    Reporting group title
    CT-P13
    Reporting group description
    		 Patients who were randomized to CT-P13-CT-P13 or CT-P13-Remicade treatment groups at Week0

    Reporting group title
    Remicade
    Reporting group description
    		 Patients who were randomized to Remicade-Remicade or Remicade-CT-P13 treatment groups at Week0
    Reporting group title
    CT-P13 - CT-P13
    Reporting group description
    		 CT-P13 followed by CT-P13 from Week 30

    Reporting group title
    CT-P13 - Remicade
    Reporting group description
    		 CT-P13 followed by Remicade from Week 30

    Reporting group title
    Remicade - Remicade
    Reporting group description
    		 Remicade followed by Remicade from Week 30

    Reporting group title
    Remicade - CT-P13
    Reporting group description
    		 Remicade followed by CT-P13 from Week 30

    Subject analysis set title
    CT-P13 - CT-P13
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The number of patients who randomized to CT-P13-CT-P13 treatment group at Week 0. CT-P13 followed by CT-P13 from Week 30

    Subject analysis set title
    CT-P13 - Remicade
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The number of patients who randomized to CT-P13-Remicade treatment group at Week 0. CT-P13 followed by Remicade from Week 30

    Subject analysis set title
    Remicade - Remicade
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The number of patients who randomized to Remicade-Remicade treatment group at Week 0. Remicade followed by Remicade from Week 30

    Subject analysis set title
    Remicade - CT-P13
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The number of patients who randomized to Remicade-CT-P13 treatment group at Week 0. Remicade followed by CT-P13 from Week 30

    Primary: CDAI-70

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    End point title
    		 CDAI-70
    End point description
    Proportion of patients achieving response according to CDAI-70 criteria at Week 6
    End point type
    Primary
    End point timeframe
    At Week 6
    End point values
    		 CT-P13 Remicade
    Number of subjects analysed
    111
    109
    Units: Participant
    77
    81
    Statistical analysis title
    		 Primary efficacy endpoint - CDAI-70 response rate
    Comparison groups
    CT-P13 v Remicade
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in response rate
    Point estimate
    -4.9
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -17
         upper limit
    		 -
    Notes
    [1] - Non-inferiority margin is -20%.

    Secondary: CDAI-70

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    End point title
    		 CDAI-70
    End point description
    Proportion of patients achieving response according to CDAI-70 criteria at Week 30
    End point type
    Secondary
    End point timeframe
    At Week 30
    End point values
    		 CT-P13 Remicade
    Number of subjects analysed
    111
    109
    Units: Participants
    85
    82
    No statistical analyses for this end point

    Secondary: CDAI-70

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    End point title
    		 CDAI-70
    End point description
    Proportion of patients achieving response according to CDAI-70 criteria at Week 54
    End point type
    Secondary
    End point timeframe
    At Week 54
    End point values
    		 CT-P13 - CT-P13 CT-P13 - Remicade Remicade - Remicade Remicade - CT-P13
    Number of subjects analysed
    56
    55
    54
    55
    Units: Participants
    44
    39
    38
    42
    No statistical analyses for this end point

    Secondary: Clinical remission

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    End point title
    		 Clinical remission
    End point description
    Proportion of patients achieving clinical remission at Week 6
    End point type
    Secondary
    End point timeframe
    At Week 6
    End point values
    		 CT-P13 Remicade
    Number of subjects analysed
    111
    109
    Units: Participants
    47
    49
    No statistical analyses for this end point

    Secondary: Clinical remission

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    End point title
    		 Clinical remission
    End point description
    Proportion of patients achieving clinical remission at Week 30
    End point type
    Secondary
    End point timeframe
    At Week 30
    End point values
    		 CT-P13 Remicade
    Number of subjects analysed
    111
    109
    Units: Participants
    61
    62
    No statistical analyses for this end point

    Secondary: Clinical remission

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    End point title
    		 Clinical remission
    End point description
    Proportion of patients achieving clinical remission at Week 54
    End point type
    Secondary
    End point timeframe
    At Week 54
    End point values
    		 CT-P13 - CT-P13 CT-P13 - Remicade Remicade - Remicade Remicade - CT-P13
    Number of subjects analysed
    56
    55
    54
    55
    Units: Participants
    35
    32
    29
    33
    No statistical analyses for this end point

    Secondary: Short Inflammatory Bowel Disease Questionnaire

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    End point title
    		 Short Inflammatory Bowel Disease Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 CT-P13 Remicade
    Number of subjects analysed
    111
    109
    Units: score
        arithmetic mean (standard deviation)
    34.3 ± 10.92
    33.9 ± 9.27
    No statistical analyses for this end point

    Secondary: Short Inflammatory Bowel Disease Questionnaire

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    End point title
    		 Short Inflammatory Bowel Disease Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 6
    End point values
    		 CT-P13 Remicade
    Number of subjects analysed
    107 [2]
    107 [3]
    Units: score
        arithmetic mean (standard deviation)
    46.4 ± 10.86
    45.8 ± 12.54
    Notes
    [2] - The number of patients who had SIBDQ score at Week 6
    [3] - The number of patients who had SIBDQ score at Week 6
    No statistical analyses for this end point

    Secondary: Short Inflammatory Bowel Disease Questionnaire

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    End point title
    		 Short Inflammatory Bowel Disease Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 30
    End point values
    		 CT-P13 Remicade
    Number of subjects analysed
    92 [4]
    88 [5]
    Units: score
        arithmetic mean (standard deviation)
    51.1 ± 11.96
    52.5 ± 10.68
    Notes
    [4] - The number of patients who had SIBDQ score at Week 30
    [5] - The number of patients who had SIBDQ score at Week 30
    No statistical analyses for this end point

    Secondary: Short Inflammatory Bowel Disease Questionnaire

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    End point title
    		 Short Inflammatory Bowel Disease Questionnaire
    End point description
    Arithmetic mean value of SIBDQ by 4 treatment groups
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 CT-P13 - CT-P13 CT-P13 - Remicade Remicade - Remicade Remicade - CT-P13
    Number of subjects analysed
    56
    55
    54
    55
    Units: score
        arithmetic mean (standard deviation)
    34.7 ± 10.61
    33.8 ± 11.31
    33.3 ± 9.77
    34.5 ± 8.81
    No statistical analyses for this end point

    Secondary: Short Inflammatory Bowel Disease Questionnaire

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    End point title
    		 Short Inflammatory Bowel Disease Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 54
    End point values
    		 CT-P13 - CT-P13 CT-P13 - Remicade Remicade - Remicade Remicade - CT-P13
    Number of subjects analysed
    45 [6]
    41 [7]
    37 [8]
    47 [9]
    Units: score
        arithmetic mean (standard deviation)
    54.4 ± 10.28
    54.1 ± 11.07
    52.6 ± 11.35
    51.2 ± 11.26
    Notes
    [6] - The number of patients who had SIBDQ score at Week 54
    [7] - The number of patients who had SIBDQ score at Week 54
    [8] - The number of patients who had SIBDQ score at Week 54
    [9] - The number of patients who had SIBDQ score at Week 54
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to End-of-Study Visit (8 weeks after Week 54 infusion)
    Adverse event reporting additional description
    Adverse events was based on Treatment Emergent (Serious) Adverse Event
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    CT-P13 - CT-P13
    Reporting group description
    		 CT-P13 followed by CT-P13 from Week 30

    Reporting group title
    CT-P13 - Remicade
    Reporting group description
    		 CT-P13 followed by Remicade from Week 30

    Reporting group title
    Remicade - Remicade
    Reporting group description
    		 Remicade followed by Remicade from Week 30

    Reporting group title
    Remicade - CT-P13
    Reporting group description
    		 Remicade followed by CT-P13 from Week 30

    Serious adverse events
    		 CT-P13 - CT-P13 CT-P13 - Remicade Remicade - Remicade Remicade - CT-P13
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 55 (7.27%)
    4 / 54 (7.41%)
    7 / 55 (12.73%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Generalised oedema
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess intestinal
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal tuberculosis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculous pleurisy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CT-P13 - CT-P13 CT-P13 - Remicade Remicade - Remicade Remicade - CT-P13
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 56 (66.07%)
    36 / 55 (65.45%)
    36 / 54 (66.67%)
    40 / 55 (72.73%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    1
    1
    0
    3
    Blood creatine phosphokinase increase
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    4 / 54 (7.41%)
    3 / 55 (5.45%)
         occurrences all number
    1
    1
    5
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    3
    1
    0
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    8 / 56 (14.29%)
    2 / 55 (3.64%)
    5 / 54 (9.26%)
    4 / 55 (7.27%)
         occurrences all number
    13
    2
    7
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    2
    0
    0
    4
    Headache
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
    2 / 54 (3.70%)
    3 / 55 (5.45%)
         occurrences all number
    3
    1
    2
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 56 (8.93%)
    5 / 55 (9.09%)
    5 / 54 (9.26%)
    4 / 55 (7.27%)
         occurrences all number
    5
    5
    5
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 56 (5.36%)
    8 / 55 (14.55%)
    5 / 54 (9.26%)
    4 / 55 (7.27%)
         occurrences all number
    3
    9
    7
    6
    Diarrhoea
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    3 / 54 (5.56%)
    0 / 55 (0.00%)
         occurrences all number
    2
    3
    3
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    2
    4
    0
    1
    Nausea
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 55 (5.45%)
    3 / 54 (5.56%)
    0 / 55 (0.00%)
         occurrences all number
    0
    4
    3
    0
    Pyrexia
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 55 (5.45%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    3
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    3 / 54 (5.56%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    4
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
    4 / 54 (7.41%)
    4 / 55 (7.27%)
         occurrences all number
    4
    1
    5
    4
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    1 / 54 (1.85%)
    3 / 55 (5.45%)
         occurrences all number
    1
    1
    1
    3
    Influenza
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 55 (1.82%)
    1 / 54 (1.85%)
    5 / 55 (9.09%)
         occurrences all number
    3
    1
    1
    6
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    3
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2014
    Summary of significant changes included the following: • Patient who has a Stoma (e.g., ileostomy or colostomy) within 6 months prior to randomization cannot enrolled in this study • Deletion of Cav, Swing, Degree of fluctuation as PK enpoints • Revision of the wording on margin justification, and define the population for primary efficacy analysis • Biomarker analysis was added as tertiary endoint • Deletion of time to loss of response up to and including Week 54 in the Week 13 responders as endpoint. • To define per-protocol definition in regarding to major deviations • Other administrative changes
    22 Dec 2014
    Summary of significant changes included the following: • To exclude patients who have been administered with any TNFα inhibitors.
    10 Feb 2015
    Summary of significant changes included the following: • Deleted PK time point after Week 22 • To exclude enteral or parenteral nutrition use during the study

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

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