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    Clinical Trial Results:
    A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared with Remicade when Co-administered with Methotrexate in Patients with Active Rheumatoid Arthritis

    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
    2010-018646-31
    Trial protocol
    SK   LV   GB   PT   IT   AT   LT   ES   BG  
    Global end of trial date
    10 Jul 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Dec 2016
    First version publication date
    23 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CT-P13-3.1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    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
    SuEun Song, CELLTRION, Inc., SuEun.Song@celltrion.com
    Scientific contact
    Sung Young Lee, CELLTRION, Inc., 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
    09 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that CT P13 was equivalent to Remicade up to Week 30, in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20).
    Protection of trial subjects
    -Hypersensitivity monitoring was performed as following. • Vital sign: 15 minutes [±5 minutes] before beginning the infusion, at the start of infusion, every 30 minutes [±5 minutes] after the start of infusion, at the end of infusion, and 30, 60, and 120 minutes [±10 minutes] after the end of infusion. - Throughout the study, patients were monitored for the clinical signs and symptoms of TB. • Premedications were given for safety of patients • Emergency equipment and medication were available. • For patients who experienced or developed life-threatening infusion-related anaphylactic reactions, infliximab treatment was stopped immediately and the patient withdrawn from the study
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Dec 2010
    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
    Poland: 143
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Romania: 19
    Country: Number of subjects enrolled
    Slovakia: 8
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Bulgaria: 32
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Latvia: 10
    Country: Number of subjects enrolled
    Lithuania: 28
    Country: Number of subjects enrolled
    Philippines: 72
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 13
    Country: Number of subjects enrolled
    Jordan: 1
    Country: Number of subjects enrolled
    Ukraine: 109
    Country: Number of subjects enrolled
    Chile: 42
    Country: Number of subjects enrolled
    Colombia: 31
    Country: Number of subjects enrolled
    Mexico: 40
    Country: Number of subjects enrolled
    Peru: 25
    Worldwide total number of subjects
    606
    EEA total number of subjects
    273
    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)
    564
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Male or female patients aged 18 to 75 years old, inclusive, who had been diagnosed with RA according to the revised 1987 ACR classification criteria

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CT-P13
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CT-P13 (3 mg/kg, IV infusion for 2hr per dose) coadministered MTX between 12.5 to 25 mg/week (oral or parenteral dose) and folic acid (≥5 mg/week, oral dose)

    Investigational medicinal product name
    Remicade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Remicade (3 mg/kg, IV infusion for 2hr per dose) coadministered MTX between 12.5 to 25 mg/week (oral or parenteral dose) and folic acid (≥5 mg/week, oral dose)

    Arm title
    Remicade
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Remicade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Remicade (3 mg/kg, IV infusion for 2hr per dose) coadministered MTX between 12.5 to 25 mg/week (oral or parenteral dose) and folic acid (≥5 mg/week, oral dose)

    Number of subjects in period 1
    CT-P13 Remicade
    Started
    302
    304
    Completed
    233
    222
    Not completed
    69
    82
         Death
    -
    1
         Protocol violation
    3
    3
         Lack of efficacy
    10
    6
         Pregnancy
    -
    1
         Adverse event, non-fatal
    36
    48
         Consent withdrawn by subject
    16
    21
         Lost to follow-up
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P13
    Reporting group description
    -

    Reporting group title
    Remicade
    Reporting group description
    -

    Reporting group values
    CT-P13 Remicade Total
    Number of subjects
    302 304 606
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    50 (18 to 75) 50 (21 to 74) -
    Gender categorical
    Units: Subjects
        Female
    245 256 501
        Male
    57 48 105

    End points

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    End points reporting groups
    Reporting group title
    CT-P13
    Reporting group description
    -

    Reporting group title
    Remicade
    Reporting group description
    -

    Subject analysis set title
    All Randomized population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomized subjects were included in All Randomized Subjects

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All randomized subjects who received a complete or partial dose of IMP were included in the Safety Analysis Set

    Subject analysis set title
    Pharmacokinetic population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects who received a dose of IMP during the 30 week blinded study period with at least one PK sample.

    Subject analysis set title
    Pharmacodynamic population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects who received a dose of IMP during the 30 week blinded study periodwith at least one PK sample.

    Subject analysis set title
    Per-protocol population up to Week 30
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects who did not have any major protocol deviations .

    Subject analysis set title
    Per-protocol population up to Week 54
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects who did not have any major protocol deviations .

    Primary: ACR20 Criteria at Weeks 30 (All-randomized Population)

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    End point title
    ACR20 Criteria at Weeks 30 (All-randomized Population)
    End point description
    Proportion of Patients Achieving Clinical Response According to the ACR20 Criteria at Weeks 30
    End point type
    Primary
    End point timeframe
    Day 210 (Week 30)
    End point values
    CT-P13 Remicade
    Number of subjects analysed
    302 [1]
    304 [2]
    Units: percentage
        number (confidence interval 95%)
    60.9 (55.17 to 66.46)
    58.9 (53.12 to 64.47)
    Notes
    [1] - All-Randomized Population
    [2] - All-Randomized Population
    Statistical analysis title
    ACR20 Criteria at Week 30
    Statistical analysis description
    Analysis Method: StatXact Version 8 or higher and PROC BINOMIAL Treatment group: treatment group, Covariates: region and C-reactive protein category Point estimates: The proportion of patients achieving clinical response defined as a 20% improvement according to ACR criteria at Week 30 was analyzed by the exact binomial approach, calculating a point estimate and 95% CI for the difference in proportion between the 2 treatment groups
    Comparison groups
    CT-P13 v Remicade
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [3]
    Method
    Parameter type
    Difference in proportion
    Point estimate
    0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.06
         upper limit
    0.1
    Notes
    [3] - Equivalence margin: -15% - 15%

    Primary: ACR20 Criteria at Weeks 30 (Per-Protocol Population)

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    End point title
    ACR20 Criteria at Weeks 30 (Per-Protocol Population)
    End point description
    Proportion of Patients Achieving Clinical Response According to the ACR20 Criteria at Weeks 30
    End point type
    Primary
    End point timeframe
    Day 210 (Week 30)
    End point values
    CT-P13 Remicade
    Number of subjects analysed
    248 [4]
    251 [5]
    Units: percentage
        number (confidence interval 95%)
    73.4 (67.43 to 78.78)
    70.1 (64.04 to 75.71)
    Notes
    [4] - Per-protocol Population
    [5] - Per-Protocol Population
    Statistical analysis title
    ACR20 Criteria at Week 30
    Comparison groups
    CT-P13 v Remicade
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [6]
    Method
    Parameter type
    Difference in proportion
    Point estimate
    0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.05
         upper limit
    0.11
    Notes
    [6] - Equivalence margin: -15% - 15%

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 434(Week 62); up to EOS
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    CT-P13
    Reporting group description
    -

    Reporting group title
    Remicade
    Reporting group description
    -

    Serious adverse events
    CT-P13 Remicade
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 302 (13.91%)
    31 / 300 (10.33%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip arthroplasty
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma stage 0
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland adenoma
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    3 / 302 (0.99%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 302 (0.33%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    2 / 302 (0.66%)
    3 / 300 (1.00%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigation
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 302 (0.00%)
    2 / 300 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Uveitis
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 302 (0.66%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (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
    Appendicitis
         subjects affected / exposed
    0 / 302 (0.00%)
    2 / 300 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coxsackie myocarditis
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 302 (0.99%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 300 (0.33%)
         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 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    CT-P13 Remicade
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    202 / 302 (66.89%)
    206 / 300 (68.67%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    15 / 302 (4.97%)
    17 / 300 (5.67%)
         occurrences all number
    18
    18
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 302 (4.64%)
    17 / 300 (5.67%)
         occurrences all number
    18
    19
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    15 / 302 (4.97%)
    10 / 300 (3.33%)
         occurrences all number
    21
    14
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    13 / 302 (4.30%)
    17 / 300 (5.67%)
         occurrences all number
    14
    20
    Latent tuberculosis
         subjects affected / exposed
    27 / 302 (8.94%)
    25 / 300 (8.33%)
         occurrences all number
    28
    28
    Nasopharyngitis
         subjects affected / exposed
    25 / 302 (8.28%)
    17 / 300 (5.67%)
         occurrences all number
    34
    18
    Upper respiratory tract infection
         subjects affected / exposed
    27 / 302 (8.94%)
    17 / 300 (5.67%)
         occurrences all number
    35
    23
    Urinary tract infection
         subjects affected / exposed
    18 / 302 (5.96%)
    21 / 300 (7.00%)
         occurrences all number
    23
    27

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 May 2010
    Summary of significant changes includes the following: •Number of sites/countries reduced • Amended administration route for Remicade and methotrexate •Amended E/C 5, 8, 9 • Removed Treatment Phase II and text associated with the study period •Updated PK and PD objectives •Clarified pregnancy testing • For countries with an increased TB prevalence and incidence, secondary endpoint was added •Updated secondary and tertiary safety endpoints •Updated infliximab measurement, immunogenicity testing, PD blood sampling •Amended blood sample and other supplies •Amended vital signs and demographics •Amended salvage retreatment •Other administrative changes
    14 Jun 2010
    Summary of significant changes includes the following: •Amended E/C 8 •Corrected Dose-Loading phase •Amended previous and concomitant treatments •Amended hypersensitivity monitoring •Clarified blinding •Clarified weight record •Other administrative changes
    10 Jan 2011
    Summary of significant changes includes the following: •Specified methotrexate administration •Amended I/C 9, 10, E/C 2, 5, 6, 8, 9 •Specified the visit window •Extended screening period •Amended EOS radiographs •Amended the secondary efficacy endpoints •Amended the joint damage and joint count •Updated a 15-minute window •Clarified rescreening of IGRA •Clarified a chest x-ray •Removed the COPD assessment •Amended AEs •Clarified sample retention and destruction •Amended the infusion time •Specified protocol analysis population •Updated phone number •Amended the body of the document •Other administrative changes

    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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