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    The EU Clinical Trials Register currently displays   39219   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind Study Assessing the Efficacy and Safety of PF-06438179 and Infliximab in Combination With Methotrexate in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

    Summary
    EudraCT number
    2013-004148-49
    Trial protocol
    LT   CZ   GB   HU   DE   PL   BG   FR  
    Global end of trial date
    01 Jun 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Jun 2018
    First version publication date
    12 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B5371002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    06 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare the efficacy between PF-06438179 and infliximab-EU in subjects with moderately to severely active RA who are treated with infliximab in combination with methotrexate.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Aug 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
    South Africa: 4
    Country: Number of subjects enrolled
    Tunisia: 1
    Country: Number of subjects enrolled
    Ukraine: 97
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 82
    Country: Number of subjects enrolled
    Jordan: 2
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 57
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    Bulgaria: 28
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Czech Republic: 73
    Country: Number of subjects enrolled
    Georgia: 45
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Guatemala: 14
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Japan: 47
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    Lithuania: 15
    Country: Number of subjects enrolled
    Mexico: 12
    Country: Number of subjects enrolled
    Peru: 15
    Country: Number of subjects enrolled
    Philippines: 34
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Russian Federation: 52
    Country: Number of subjects enrolled
    Serbia: 13
    Worldwide total number of subjects
    650
    EEA total number of subjects
    154
    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)
    518
    From 65 to 84 years
    131
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1603 subjects were screened after signing an informed consent form, of whom 650 subjects were randomized to receive study treatment. One (1) subject in the PF-06438179 arm was screened and randomized by 2 different study site personnel, and no data were collected for the subjects second randomization.

    Period 1
    Period 1 title
    Period 1: First dose-Week 30 (pre-dose)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    PF-06438179
    Arm description
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-06438179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Arm title
    Infliximab-EU Remicade (INX)
    Arm description
    Subjects received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.
    Arm type
    Experimental

    Investigational medicinal product name
    Infliximab-EU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Number of subjects in period 1
    PF-06438179 Infliximab-EU Remicade (INX)
    Started
    324
    326
    Received treatment
    323
    326
    Completed
    280
    286
    Not completed
    44
    40
         Randomized but not treated
    1
    -
         Protocol deviation
    5
    1
         Non-compliance with study treatment
    1
    -
         Pregnancy
    2
    -
         Adverse event, serious fatal
    2
    2
         Adverse event, non-fatal
    18
    20
         Unspecified
    4
    -
         Consent withdrawn by subject
    11
    9
         Insufficient clinical response
    -
    7
         Lost to follow-up
    -
    1
    Period 2
    Period 2 title
    Period 2: Week30 dosing-Week54(pre-dose)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    PF-06438179
    Arm description
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-06438179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Arm title
    Infliximab-EU Remicade (INX)
    Arm description
    Subjects received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.
    Arm type
    Active comparator

    Investigational medicinal product name
    Infliximab-EU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Number of subjects in period 2
    PF-06438179 Infliximab-EU Remicade (INX)
    Started
    423
    143
    Completed
    380
    126
    Not completed
    43
    17
         Non-compliance with study treatment
    1
    -
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    22
    9
         Consent withdrawn by subject
    6
    4
         Unspecified
    3
    -
         Insufficient clinical response
    9
    3
         Lost to follow-up
    1
    1
    Period 3
    Period 3 title
    Period 3: Week 54 dosing-Week 78 visit
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    PF-06438179
    Arm description
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-06438179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Number of subjects in period 3 [1]
    PF-06438179
    Started
    505
    Completed
    474
    Not completed
    31
         Non-compliance with study treatment
    1
         Adverse event, non-fatal
    14
         Consent withdrawn by subject
    9
         Unspecified
    4
         Insufficient clinical response
    3
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects in Infliximab-EU arm were switched to PF-06438179 arm in preceding periods; and in Period 3 all subjects were switched to PF-06438179 arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-06438179
    Reporting group description
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Reporting group title
    Infliximab-EU Remicade (INX)
    Reporting group description
    Subjects received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Reporting group values
    PF-06438179 Infliximab-EU Remicade (INX) Total
    Number of subjects
    324 326 650
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    259 259 518
        From 65-84 years
    64 67 131
        85 years and over
    1 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    52.8 ± 13.3 52.8 ± 12.9 -
    Gender, Male/Female
    Units: Subjects
        Female
    258 264 522
        Male
    66 62 128
    Subject analysis sets

    Subject analysis set title
    Period 1: PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.

    Subject analysis set title
    Period 1: Infliximab-EU Remicade (INX)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.

    Subject analysis set title
    Period 2: PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Subject analysis set title
    Period 2: INX/INX
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Subject analysis set title
    Period 2: INX/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Subject analysis set title
    Period 3: PF-06438179/PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 3: INX/INX/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 3: INX/PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 3: INX/INX/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 3: INX/PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 1: PF-06438179
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.

    Subject analysis set title
    Period 3: PF-06438179/PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis sets values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX) Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 1: PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179
    Number of subjects
    324
    326
    280
    143
    143
    253
    126
    126
    126
    126
    323
    253
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    52.8 ± 13.3
    52.8 ± 12.9
    52.8 ± 12.9
    53.8 ± 12.7
    51.6 ± 12.9
    52.4 ± 12.8
    53.5 ± 12.4
    51.3 ± 12.6
    53.5 ± 12.4
    51.3 ± 12.6
    52.8 ± 13.3
    52.4 ± 12.8
    Gender, Male/Female
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    PF-06438179
    Reporting group description
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Reporting group title
    Infliximab-EU Remicade (INX)
    Reporting group description
    Subjects received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.
    Reporting group title
    PF-06438179
    Reporting group description
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Reporting group title
    Infliximab-EU Remicade (INX)
    Reporting group description
    Subjects received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.
    Reporting group title
    PF-06438179
    Reporting group description
    Subjects received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Subjects initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when subjects initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the subjects switching to PF-06438179 and the other 50% of subjects remaining on the INX arm. Period 3 started with dosing at Week 54 where all subjects began open label treatment with PF-06438179.

    Subject analysis set title
    Period 1: PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.

    Subject analysis set title
    Period 1: Infliximab-EU Remicade (INX)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.

    Subject analysis set title
    Period 2: PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Subject analysis set title
    Period 2: INX/INX
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Subject analysis set title
    Period 2: INX/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Subject analysis set title
    Period 3: PF-06438179/PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 3: INX/INX/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 3: INX/PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 3: INX/INX/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 3: INX/PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Subject analysis set title
    Period 1: PF-06438179
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.

    Subject analysis set title
    Period 3: PF-06438179/PF-06438179/PF-06438179
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Primary: Number of Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1

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    End point title
    Number of Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
    End point description
    ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP). The ITT Population was defined as all subjects who were randomized to study treatment.
    End point type
    Primary
    End point timeframe
    Week 14
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    324
    326
    Units: subjects
    198
    207
    Statistical analysis title
    PF-06438179 vs Infliximab-EU
    Statistical analysis description
    Score statistic method
    Comparison groups
    Period 1: PF-06438179 v Period 1: Infliximab-EU Remicade (INX)
    Number of subjects included in analysis
    650
    Analysis specification
    Pre-specified
    Analysis type
    [1]
    Method
    Parameter type
    Proportion Difference
    Point estimate
    -2.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.92
         upper limit
    5.11
    Notes
    [1] - Equivalence test
    Statistical analysis title
    PF-06438179 vs Infliximab-EU
    Statistical analysis description
    Score statistic method
    Comparison groups
    Period 1: PF-06438179 v Period 1: Infliximab-EU Remicade (INX)
    Number of subjects included in analysis
    650
    Analysis specification
    Pre-specified
    Analysis type
    [2]
    Method
    Parameter type
    Proportion Difference
    Point estimate
    -2.39
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.75
         upper limit
    4.02
    Notes
    [2] - Equivalence test

    Secondary: Number of Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (pre-dose): Period 1

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    End point title
    Number of Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (pre-dose): Period 1
    End point description
    ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP. The ITT Population was defined as all subjects who were randomized to study treatment.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 6, 12, 22 and 30 (pre-dose)
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    324
    326
    Units: subjects
        Week 2
    105
    121
        Week 4
    170
    190
        Week 6
    187
    201
        Week 12
    210
    214
        week 22
    205
    213
        Week 30 (pre-dose)
    197
    209
    No statistical analyses for this end point

    Secondary: Number of Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (pre-dose): Period 2

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    End point title
    Number of Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (pre-dose): Period 2
    End point description
    ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP. The ITT Population was defined as all subjects who were randomized to study treatment.
    End point type
    Secondary
    End point timeframe
    Week 38, 46 and 54 (pre-dose)
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    280
    143
    143
    Units: subjects
        Week 38
    206
    101
    110
        Week 46
    199
    98
    99
        Week 54 (pre-dose)
    199
    92
    101
    No statistical analyses for this end point

    Secondary: Number of Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3

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    End point title
    Number of Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3
    End point description
    ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP. The ITT population included all subjects enrolled and treated with at least 1 dose of study treatment in Period 3.
    End point type
    Secondary
    End point timeframe
    Week 62, 70 and 78
    End point values
    Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179
    Number of subjects analysed
    253
    126
    126
    Units: subjects
        Week 62
    199
    89
    103
        Week 70
    199
    87
    98
        Week 78
    192
    86
    98
    No statistical analyses for this end point

    Secondary: Number of Subjects With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose): Period 1

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    End point title
    Number of Subjects With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose): Period 1
    End point description
    ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: subject assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: subject assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. The ITT Population was defined as all subjects who were randomized to study treatment.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    324
    326
    Units: subjects
        ACR50 (Week 2)
    24
    24
        ACR50 (Week 4)
    72
    59
        ACR50 (Week 6)
    88
    80
        ACR50 (Week 12)
    95
    101
        ACR50 (Week 14)
    116
    108
        ACR50 (Week 22)
    126
    116
        ACR50 (Week 30, pre-dose)
    125
    132
        ACR70 (Week 2)
    6
    6
        ACR70 (Week 4)
    22
    13
        ACR70 (Week 6)
    33
    16
        ACR70 (Week 12)
    46
    40
        ACR70 (Week 14)
    56
    33
        ACR70 (Week 22)
    56
    45
        ACR70 (Week 30, pre-dose)
    67
    58
    No statistical analyses for this end point

    Secondary: Number of Subjects With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (pre-dose): Period 2

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    End point title
    Number of Subjects With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (pre-dose): Period 2
    End point description
    ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: subject assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: subject assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. The ITT Population was defined as all subjects who were randomized to study treatment.
    End point type
    Secondary
    End point timeframe
    Week 38, 46 and 54 (pre-dose)
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    280
    143
    143
    Units: subjects
        ACR50 (Week 38)
    132
    58
    75
        ACR50 (Week 46)
    135
    55
    63
        ACR50 (Week 54, pre-dose)
    135
    61
    65
        ACR70 (Week 38)
    77
    33
    38
        ACR70 (Week 46)
    75
    33
    33
        ACR70 (Week 54, pre-dose)
    82
    33
    35
    No statistical analyses for this end point

    Secondary: Number of Subjects With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3

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    End point title
    Number of Subjects With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3
    End point description
    ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: subject assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: subject assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. The ITT population included all subjects enrolled and treated with at least 1 dose of study treatment in Period 3.
    End point type
    Secondary
    End point timeframe
    Week 62, 70 and 78
    End point values
    Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179
    Number of subjects analysed
    253
    126
    126
    Units: subjects
        ACR50 (Week 62)
    132
    59
    71
        ACR50 (Week 70)
    142
    61
    67
        ACR50 (Week 78)
    150
    57
    73
        ACR70 (Week 62)
    88
    31
    41
        ACR70 (Week 70)
    92
    35
    44
        ACR70 (Week 78)
    98
    33
    44
    No statistical analyses for this end point

    Secondary: Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

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    End point title
    Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
    End point description
    DAS28: measure of disease activity in subjects. DAS28-4 (CRP): calculated from SJC, TJC, CRP and PGA (participant rated disease activity on visual analogue scale [VAS] from 0-100 millimetres [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0(no) to 9.4(extreme disease activity), higher score=more disease activity (less than [<] 2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity). HAQ-DI assess degree of difficulty subject experienced in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on 4-point scale ranging from 0-3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range 0(least difficulty) to 3(extreme difficulty): high score=more difficulty in performing daily living activities. ITT Population. n=subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    324
    326
    Units: units on a scale
    arithmetic mean (standard deviation)
        DAS28-CRP (Baseline; n= 321, 325)
    5.950 ± 0.9577
    5.983 ± 0.9210
        DAS28-CRP (Change at Week 2; n= 318, 324)
    -1.213 ± 0.9280
    -1.241 ± 0.8879
        DAS28-CRP (Change at Week 4; n= 312, 315)
    -1.596 ± 1.1259
    -1.605 ± 1.0881
        DAS28-CRP (Change at Week 6; n= 312, 319)
    -1.710 ± 1.1959
    -1.750 ± 1.0885
        DAS28-CRP (Change at Week 12; n= 310, 316)
    -1.898 ± 1.3516
    -1.885 ± 1.2142
        DAS28-CRP (Change at Week 14; n= 310, 314)
    -1.901 ± 1.4125
    -1.827 ± 1.3019
        DAS28-CRP (Change at Week 22; n= 301, 307)
    -2.005 ± 1.4236
    -2.002 ± 1.2972
        DAS28-CRP (Change at Week 30; n= 292, 297)
    -2.140 ± 1.4197
    -2.117 ± 1.2738
        HAQ-DI (Baseline; n= 321, 325)
    1.623 ± 0.6485
    1.586 ± 0.6490
        HAQ-DI (Change at Week 2; n= 320, 324)
    -0.317 ± 0.4100
    -0.328 ± 0.4370
        HAQ-DI (Change at Week 4; n= 317, 321)
    -0.472 ± 0.4728
    -0.477 ± 0.4861
        HAQ-DI (Change at Week 6; n= 314, 320)
    -0.496 ± 0.5505
    -0.520 ± 0.5022
        HAQ-DI (Change at Week 12; n= 311, 318)
    -0.535 ± 0.5795
    -0.524 ± 0.5857
        HAQ-DI (Change at Week 14; n= 311, 316)
    -0.572 ± 0.5910
    -0.531 ± 0.5876
        HAQ-DI (Change at Week 22; n= 301, 311)
    -0.588 ± 0.6061
    -0.569 ± 0.5958
        HAQ-DI (Change at Week 30; n= 294, 298)
    -0.621 ± 0.6484
    -0.612 ± 0.6546
    No statistical analyses for this end point

    Secondary: Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2

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    End point title
    Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2
    End point description
    DAS28: measure of disease activity in subjects. DAS28-4 (CRP): calculated from SJC, TJC, CRP and PGA (participant rated disease activity on VAS from 0-100 mm; high score =worse health). Total score range of DAS28-4 (CRP): 0(no) to 9.4(extreme disease activity), higher score=more disease activity (<2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity). HAQ-DI assess degree of difficulty subject experienced in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on 4-point scale ranging from 0-3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range 0(least difficulty) to 3(extreme difficulty): high score=more difficulty in performing daily living activities. ITT Population. N=subjects evaluable for this outcome measure, n=subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 30 pre-dose), Week 38, 46 and 54
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    278
    142
    141
    Units: units on a scale
    arithmetic mean (standard deviation)
        DAS28-CRP (Baseline; n= 278, 142, 141)
    3.765 ± 1.4629
    3.819 ± 1.3624
    3.781 ± 1.2547
        DAS28-CRP (Change at Week 38; n= 276, 141, 140)
    -0.181 ± 0.9574
    0.036 ± 0.8686
    -0.059 ± 0.8756
        DAS28-CRP (Change at Week 46; n= 266, 138, 133)
    -0.228 ± 1.0453
    0.048 ± 1.2584
    -0.017 ± 1.0692
        DAS28-CRP (Change at Week 54; n= 256, 129, 128)
    -0.275 ± 1.1338
    -0.109 ± 1.1801
    -0.057 ± 1.2339
        HAQ-DI (Change at Baseline; n= 278, 142, 141)
    0.978 ± 0.7042
    0.913 ± 0.6634
    0.951 ± 0.6481
        HAQ-DI (Change at Week 38; n= 277, 141, 141)
    -0.019 ± 0.3328
    0.019 ± 0.2889
    0.007 ± 0.3688
        HAQ-DI (Change at Week 46; n= 269, 138, 133)
    -0.043 ± 0.3774
    0.014 ± 0.3823
    0.035 ± 0.4325
        HAQ-DI (Change at Week 54; n= 259, 130, 129)
    -0.026 ± 0.4407
    0.017 ± 0.4399
    -0.044 ± 0.3881
    No statistical analyses for this end point

    Secondary: Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3

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    End point title
    Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3
    End point description
    DAS28: measure of disease activity in subjects. DAS28-4 (CRP): calculated from SJC, TJC, CRP and PGA (participant rated disease activity on VAS from 0-100 mm; high score =worse health). Total score range of DAS28-4 (CRP): 0(no) to 9.4(extreme disease activity), higher score=more disease activity (<2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity). HAQ-DI assess degree of difficulty subject experienced in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on 4-point scale ranging from 0-3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range 0(least difficulty) to 3(extreme difficulty): high score=more difficulty in performing daily living activities. ITT Population. N=subjects evaluable for this outcome measure, n=subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 54 pre-dose), Week 62, 70 and 78
    End point values
    Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179
    Number of subjects analysed
    249
    123
    126
    Units: units on a scale
    arithmetic mean (standard deviation)
        DAS28-CRP (Baseline; n= 249, 123, 124)
    3.386 ± 1.3229
    3.561 ± 1.3123
    3.594 ± 1.2572
        DAS28-CRP (Change at Week 62; n= 249, 123, 124)
    -0.072 ± 0.9150
    -0.004 ± 0.8190
    -0.154 ± 0.6840
        DAS28-CRP (Change at Week 70; n= 244, 119, 121)
    -0.157 ± 0.9502
    -0.168 ± 0.8421
    -0.162 ± 0.7970
        DAS28-CRP (Change at Week 78; n= 239, 114, 118)
    -0.236 ± 1.0361
    -0.269 ± 0.9759
    -0.215 ± 1.0584
        HAQ-DI (Baseline; n= 249, 123, 124)
    0.905 ± 0.7050
    0.893 ± 0.6691
    0.883 ± 0.6109
        HAQ-DI (Change at Week 62; n= 249, 123, 124)
    -0.024 ± 0.3126
    0.021 ± 0.2989
    0.008 ± 0.2942
        HAQ-DI (Change at Week 70; n= 244, 119, 121)
    -0.046 ± 0.3502
    -0.027 ± 0.2758
    0.030 ± 0.2950
        HAQ-DI (Change at Week 78; n= 239, 114, 118)
    -0.079 ± 0.3869
    -0.022 ± 0.3521
    0.001 ± 0.3800
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1

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    End point title
    Number of Subjects Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1
    End point description
    ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP, and patient’s global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI: sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores=worse health condition. Physician global assessment was recorded on 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores=more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP and PGA using a 10 mm-VAS (from 0 [very well] to 10 [very poor], where higher scores=worse health condition. DAS28 <3.2: low disease activity, DAS28<2.6: remission. The ITT Population was defined as all subjects who were randomized to study treatment.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    324
    326
    Units: subjects
        ACR/EULAR remission (Week 2)
    2
    3
        ACR/EULAR remission (Week 4)
    10
    11
        ACR/EULAR remission (Week 6)
    12
    10
        ACR/EULAR remission (Week 12)
    28
    17
        ACR/EULAR remission (Week 14)
    27
    22
        ACR/EULAR remission (Week 22)
    25
    20
        ACR/EULAR remission (Week 30, pre-dose)
    30
    23
        DAS remission (Week 2)
    9
    17
        DAS remission (Week 4)
    28
    32
        DAS remission (Week 6)
    40
    35
        DAS remission (Week 12)
    52
    44
        DAS remission (Week 14)
    53
    43
        DAS remission (Week 22)
    58
    50
        DAS remission (Week 30, pre-dose)
    62
    54
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2

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    End point title
    Number of Subjects Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2
    End point description
    ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP, and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI: sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores=worse health condition. Physician global assessment was recorded on 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores=more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP and PGA using a 10 mm-VAS (from 0 [very well] to 10 [very poor], where higher scores=worse health condition. DAS28 <3.2: low disease activity, DAS28<2.6: remission. The ITT Population was defined as all subjects who were randomized to study treatment.
    End point type
    Secondary
    End point timeframe
    Week 38, 46 and 54 (pre-dose)
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    280
    143
    143
    Units: subjects
        ACR/EULAR remission (Week 38)
    29
    15
    8
        ACR/EULAR remission (Week 46)
    39
    15
    7
        ACR/EULAR remission (Week 54, pre-dose)
    42
    18
    13
        DAS remission (Week 38)
    74
    26
    25
        DAS remission (Week 46)
    76
    30
    21
        DAS remission (Week 54, pre-dose)
    79
    33
    29
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3

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    End point title
    Number of Subjects Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3
    End point description
    ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP, and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI: sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores=worse health condition. Physician global assessment was recorded on 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores=more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP and PGA using a 10 mm-VAS (from 0 [very well] to 10 [very poor], where higher scores=worse health condition. DAS28 <3.2: low disease activity, DAS28<2.6: remission. The ITT Population was defined as all subjects who were randomized to study treatment.
    End point type
    Secondary
    End point timeframe
    Week 62, 70 and 78
    End point values
    Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179
    Number of subjects analysed
    253
    126
    126
    Units: subjects
        ACR/EULAR remission (Week 62)
    46
    19
    20
        ACR/EULAR remission (Week 70)
    50
    18
    19
        ACR/EULAR remission (Week 78)
    57
    19
    18
        DAS remission (Week 62)
    85
    33
    34
        DAS remission (Week 70)
    82
    40
    34
        DAS remission (Week 78)
    94
    39
    41
    No statistical analyses for this end point

    Secondary: Number of Subjects With European League Against Rheumatism (EULAR) Response: Period 1

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    End point title
    Number of Subjects With European League Against Rheumatism (EULAR) Response: Period 1
    End point description
    EULAR response was based on DAS28 EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 =<3.2; Moderate response = DAS28 change >0.6-=<1.2 with DAS28 >3.2-5.1; no-response = DAS28 change =<0.6 with DAS28 >5.1. The ITT Population was defined as all subjects who were randomized to study treatment. Here, "n" signifies number of subjects who were evaluable for the specified categories, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 6, 12, 14, 22, 30 (pre-dose)
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    324
    326
    Units: subjects
        Week 2 (good response; n= 317, 324)
    24
    34
        Week 2 (moderate response; n= 317, 324)
    172
    161
        Week 2 (no response; n= 317, 324)
    121
    129
        Week 4 (good response; n= 312, 315)
    61
    56
        Week 4 (moderate response; n= 312, 315)
    162
    172
        Week 4 (no response; n= 312, 315)
    89
    87
        Week 6 (good response; n= 312, 319)
    65
    64
        Week 6 (moderate response; n= 312, 319)
    168
    181
        Week 6 (no response; n= 312, 319)
    79
    74
        Week 12 (good response; n= 310, 316)
    90
    88
        Week 12 (moderate response; n= 310, 316)
    149
    162
        Week 12 (no response; n= 310, 316)
    71
    66
        Week 14 (good response; n= 310, 314)
    97
    82
        Week 14 (moderate response; n= 310, 314)
    137
    155
        Week 14 (no response; n= 310, 314)
    76
    77
        Week 22 (good response; n= 301, 307)
    103
    96
        Week 22 (moderate response; n= 301, 307)
    125
    156
        Week 22 (no response; n= 301, 307)
    73
    55
        Week 30 (good response; n= 292, 297)
    101
    94
        Week 30 (moderate response; n= 292, 297)
    133
    155
        Week 30 (no response; n= 292, 297)
    58
    48
    No statistical analyses for this end point

    Secondary: Number of Subjects With European League Against Rheumatism (EULAR) Response: Period 2

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    End point title
    Number of Subjects With European League Against Rheumatism (EULAR) Response: Period 2
    End point description
    EULAR response was based on DAS28 EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 =<3.2; Moderate response = DAS28 change >0.6-=<1.2 with DAS28 >3.2-5.1; no-response = DAS28 change =<0.6 with DAS28 >5.1. The ITT Population was defined as all subjects who were randomized to study treatment. Here, "n" signifies number of subjects who were evaluable for the specified categories, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Week 38, 46 and 54 (pre-dose)
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    280
    143
    143
    Units: subjects
        Week 38 (good response; n= 276, 141, 140)
    110
    51
    49
        Week 38 (moderate response; n= 276, 141, 140)
    132
    62
    66
        Week 38 (no response; n= 276, 141, 140)
    34
    28
    25
        Week 46 (good response; n= 266, 138, 133)
    107
    46
    49
        Week 46 (moderate response; n= 266, 138, 133)
    126
    64
    67
        Week 46 (no response; n= 266, 138, 133)
    33
    28
    17
        Week 54 (good response; n= 256, 129, 128)
    118
    53
    50
        Week 54 (moderate response; n= 256, 129, 128)
    109
    56
    62
        Week 54 (no response; n= 256, 129, 128)
    29
    20
    16
    No statistical analyses for this end point

    Secondary: Number of Subjects With European League Against Rheumatism (EULAR) Response: Period 3

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    End point title
    Number of Subjects With European League Against Rheumatism (EULAR) Response: Period 3
    End point description
    EULAR response was based on DAS28 EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 =<3.2; Moderate response = DAS28 change >0.6-=<1.2 with DAS28 >3.2-5.1; no-response = DAS28 change =<0.6 with DAS28 >5.1. The ITT population included all subjects enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "n" signifies number of subjects who were evaluable for the specified categories, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Week 62, 70 and 78
    End point values
    Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179
    Number of subjects analysed
    253
    126
    126
    Units: subjects
        Week 62 (good response; n= 249, 123, 124)
    122
    50
    57
        Week 62 (moderate response; n= 249, 123, 124)
    102
    56
    54
        Week 62 (no response; n= 249, 123, 124)
    25
    17
    13
        Week 70 (good response; n= 244, 119, 121)
    127
    56
    52
        Week 70 (moderate response; n= 244, 119, 121)
    92
    48
    54
        Week 70 (no response; n= 244, 119, 121)
    25
    15
    15
        Week 78 (good response; n= 239, 114, 118)
    133
    58
    57
        Week 78 (moderate response; n= 239, 114, 118)
    84
    45
    53
        Week 78 (no response; n= 239, 114, 118)
    22
    11
    8
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 30
    End point values
    Period 1: Infliximab-EU Remicade (INX) Period 1: PF-06438179
    Number of subjects analysed
    326
    323
    Units: subjects
        TEAEs
    176
    185
        SAEs
    20
    16
        Treatment related TEAEs
    75
    81
        Treatment related SAEs
    4
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 30 pre-dose) up to Week 54
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    280
    143
    143
    Units: subjects
        TEAEs
    103
    48
    54
        SAEs
    13
    11
    4
        Treatment related TEAEs
    32
    20
    16
        Treatment related SAEs
    2
    5
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 54) up to Week 78
    End point values
    Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179
    Number of subjects analysed
    253
    126
    126
    Units: subjets
        TEAEs
    73
    38
    37
        SAEs
    3
    3
    6
        Treatment related TEAEs
    22
    10
    8
        Treatment related SAEs
    0
    1
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1
    End point description
    AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 30
    End point values
    Period 1: Infliximab-EU Remicade (INX) Period 1: PF-06438179
    Number of subjects analysed
    326
    323
    Units: subjects
        TEAEs (Grade 3)
    34
    34
        TEAEs (Grade 4)
    6
    1
        TEAEs (Grade 5)
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2
    End point description
    AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 30 pre-dose) up to Week 54
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    280
    143
    143
    Units: subjects
        TEAEs (Grade 3)
    17
    10
    6
        TEAEs (Grade 4)
    3
    3
    0
        TEAEs (Grade 5)
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3

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    End point title
    Number of subjects With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3
    End point description
    AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 54 pre-dose) up to Week 78
    End point values
    Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179
    Number of subjects analysed
    126
    126
    253
    Units: subjects
        TEAEs (Grade 3)
    3
    7
    4
        TEAEs (Grade 4)
    0
    0
    1
        TEAEs (Grade 5)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Abnormalities: Treatment Period 1

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    End point title
    Number of Subjects With Laboratory Abnormalities: Treatment Period 1
    End point description
    Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Safety population was defined as all subjects who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 30
    End point values
    Period 1: Infliximab-EU Remicade (INX) Period 1: PF-06438179
    Number of subjects analysed
    325
    321
    Units: subjects
    237
    245
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Abnormalities: Treatment Period 2

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    End point title
    Number of Subjects With Laboratory Abnormalities: Treatment Period 2
    End point description
    Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Safety population was defined as all subjects who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 30 pre-dose) up to Week 54
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    279
    142
    141
    Units: subjects
    154
    83
    63
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Abnormalities: Treatment Period 3

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    End point title
    Number of Subjects With Laboratory Abnormalities: Treatment Period 3
    End point description
    Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Safety population was defined as all subjects who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 54 pre-dose) up to Week 78
    End point values
    Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179
    Number of subjects analysed
    123
    126
    250
    Units: subjects
    72
    61
    127
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

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    End point title
    Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
    End point description
    Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent. The ITT Population was defined as all subjects who were randomized to study treatment. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this endpoint and “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    321
    325
    Units: joints
    arithmetic mean (standard deviation)
        Tender joint count:Baseline; n= 321,325
    24.7 ± 13.90
    25.8 ± 12.89
        Tender joint count:Change at Week 2; n= 319,324
    -5.9 ± 8.78
    -7.5 ± 8.39
        Tender joint count:Change at Week 4; n= 317,321
    -9.5 ± 10.02
    -10.4 ± 9.41
        Tender joint count:Change at Week 6; n= 313,319
    -10.6 ± 11.17
    -12.1 ± 10.12
        Tender joint count:Change at Week 12; n= 311,318
    -12.1 ± 11.84
    -13.2 ± 11.51
        Tender joint count:Change at Week 14; n= 311,316
    -11.8 ± 12.50
    -13.0 ± 12.15
        Tender joint count:Change at Week 22; n= 301,311
    -13.2 ± 12.62
    -15.2 ± 12.93
        Tender joint count:Change at Week 30; n= 294,298
    -14.4 ± 13.19
    -15.6 ± 12.57
        Swollen joint count:Baseline; n= 321,325
    16.1 ± 9.44
    16.3 ± 8.70
        Swollen joint count:Change at Week 2; n= 319,324
    -5.5 ± 6.89
    -5.7 ± 7.27
        Swollen joint count:Change at Week 4; n= 317,321
    -7.8 ± 7.75
    -7.9 ± 7.39
        Swollen joint count:Change at Week 6; n= 313,319
    -8.6 ± 7.99
    -9.0 ± 7.92
        Swollen joint count:Change at Week 12; n= 311,318
    -9.6 ± 8.61
    -9.6 ± 8.39
        Swollen joint count:Change at Week 14; n= 311,316
    -9.3 ± 8.87
    -9.6 ± 8.44
        Swollen joint count:Change at Week 22; n= 301,311
    -10.5 ± 8.77
    -10.2 ± 7.94
        Swollen joint count:Change at Week 30; n= 294,298
    -11.0 ± 9.33
    -10.7 ± 8.52
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2

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    End point title
    Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2
    End point description
    Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent. The ITT Population was defined as all subjects who were randomized to study treatment. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this endpoint and “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 30 pre-dose), Week 38, 46 and 54
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    278
    142
    141
    Units: joints
    arithmetic mean (standard deviation)
        Tender joint count:Baseline;n= 278,142,141
    10.2 ± 11.74
    10.2 ± 11.96
    9.1 ± 8.89
        Tender joint count:Change at Week 38;n=277,141,141
    -1.3 ± 6.74
    -0.5 ± 8.86
    -1.0 ± 6.03
        Tender joint count:Change at Week 46;n=269,138,133
    -1.6 ± 7.87
    -1.0 ± 9.32
    -0.8 ± 7.77
        Tender joint count:Change at Week 54;n=260,130,129
    -1.7 ± 7.96
    -1.7 ± 10.23
    -0.5 ± 9.03
        Swollen joint count:Baseline;n=278,142,141
    4.9 ± 6.46
    5.3 ± 6.57
    4.6 ± 5.35
        Swollen jointcount:Change at Week 38;n=277,141,141
    -0.8 ± 4.19
    -0.1 ± 4.90
    -0.3 ± 3.93
        Swollen jointcount:Change at Week 46;n=269,138,133
    -1.2 ± 5.20
    0.0 ± 5.54
    -0.5 ± 4.22
        Swollen jointcount:Change at Week 54;n=260,130,129
    -1.3 ± 5.52
    -0.9 ± 7.02
    -0.7 ± 4.10
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3

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    End point title
    Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3
    End point description
    Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent. The ITT population included all subjects enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this endpoint and “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 54 pre-dose), Week 62, 70 and 78
    End point values
    Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179
    Number of subjects analysed
    123
    126
    249
    Units: joints
    arithmetic mean (standard deviation)
        Tender joint count:Baseline;n=249,123,126
    7.5 ± 9.21
    7.4 ± 7.99
    7.5 ± 9.51
        Tender joint count:Change at Week 62;n=249,123,124
    0.3 ± 5.21
    -0.8 ± 5.18
    -0.7 ± 5.88
        Tender joint count:Change at Week 70;n=244,119,122
    -0.6 ± 5.14
    -1.0 ± 5.51
    -1.4 ± 6.32
        Tender joint count:Change at Week 78;n=239,116,118
    -1.0 ± 5.82
    -1.4 ± 6.63
    -1.7 ± 6.57
        Swollen jointcount:Baseline; n=249,123,126
    4.1 ± 5.16
    3.5 ± 4.28
    3.4 ± 5.72
        Swollen jointcount:Change at Week 62;n=249,123,124
    0.0 ± 4.41
    -0.3 ± 2.72
    -0.3 ± 3.76
        Swollen jointcount:Change at Week 70;n=244,119,122
    -0.4 ± 4.12
    -0.5 ± 2.48
    -0.7 ± 4.60
        Swollen jointcount:Change at Week 78;n=239,116,118
    -0.5 ± 4.00
    -0.2 ± 3.14
    -0.9 ± 4.63
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1

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    End point title
    Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1
    End point description
    PAAP: Subjects assessed the severity of their arthritis pain by using 100 mm VAS ranging from 0-100(no pain-most severe pain):corresponded to the magnitude of their pain, higher scores=more pain. PGA: subjects were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” and response was recorded on 100 mm VAS ranging from 0-100(no pain-most severe pain), where higher scores=worse health condition. PGAA: Subjects were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the subject’s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician’s response was recorded using a 100 mm VAS ranging from 0-100(no pain-most severe pain), where higher scores=more disease activity. ITT Population. Here, "Number of Subjects Analyzed"=subjects evaluable for this outcome measure and “n”=subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    321
    325
    Units: units on a scale
    arithmetic mean (standard deviation)
        PAAP: Baseline; n= 321, 325
    63.514 ± 20.5903
    63.098 ± 21.5442
        PAAP: Change at Week 2; n= 320, 324
    -15.724 ± 21.9589
    -15.360 ± 19.4328
        PAAP: Change at Week 4; n= 317, 321
    -21.609 ± 22.3825
    -20.552 ± 21.2670
        PAAP: Change at Week 6; n= 314, 320
    -23.917 ± 25.0213
    -22.797 ± 22.9133
        PAAP: Change at Week 12; n= 311, 318
    -25.364 ± 25.6602
    -25.829 ± 24.8304
        PAAP: Change at Week 14; n= 311, 316
    -26.131 ± 26.8712
    -25.077 ± 25.0536
        PAAP: Change at week 22; n= 301, 311
    -27.844 ± 27.0039
    -25.788 ± 25.3225
        PAAP: Change at Week 30; n= 294, 298
    -29.150 ± 27.9802
    -28.853 ± 26.7252
        PGA: Baseline; n= 321, 325
    65.340 ± 20.7209
    63.752 ± 22.9105
        PGA: Change at Week 2; n= 320, 324
    -17.262 ± 22.8767
    -16.504 ± 20.3188
        PGA: Change at Week 4; n= 317, 321
    -23.393 ± 23.3769
    -21.355 ± 23.6005
        PGA: Change at Week 6; n= 314, 320
    -25.536 ± 24.8041
    -23.314 ± 24.2005
        PGA: Change at Week 12; n= 311, 317
    -26.882 ± 25.3270
    -26.535 ± 26.3998
        PGA: Change at Week 14; n= 311, 316
    -27.583 ± 26.7955
    -25.323 ± 26.8562
        PGA: Change at week 22; n= 301, 310
    -28.558 ± 27.5077
    -26.486 ± 26.7141
        PGA: Change at Week 30; n= 294, 298
    -29.186 ± 28.6488
    -28.814 ± 28.5929
        PGAA: Baseline; n= 319, 325
    65.362 ± 16.2520
    64.126 ± 16.7220
        PGAA: Change at Week 2; n= 318, 324
    -21.913 ± 18.5574
    -20.143 ± 17.1407
        PGAA: Change at Week 4; n= 315, 321
    -29.724 ± 19.2226
    -27.905 ± 17.9803
        PGAA: Change at Week 6; n= 312, 320
    -33.319 ± 20.1143
    -30.958 ± 18.9303
        PGAA: Change at Week 12; n= 310, 318
    -34.827 ± 19.8162
    -33.919 ± 19.7020
        PGAA: Change at Week 14; n= 310, 316
    -35.870 ± 21.4707
    -34.175 ± 20.6526
        PGAA: Change at Week 22; n= 300, 311
    -37.542 ± 20.8619
    -36.118 ± 20.6564
        PGAA: Change at Week 30; n= 293, 298
    -39.842 ± 22.0276
    -36.666 ± 22.1598
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2

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    End point title
    Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2
    End point description
    PAAP: Subjects assessed the severity of their arthritis pain by using 100 mm VAS ranging from 0-100(no pain-most severe pain):corresponded to the magnitude of their pain, higher scores=more pain. PGA: subjects were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” and response was recorded on 100 mm VAS ranging from 0-100(no pain-most severe pain), where higher scores=worse health condition. PGAA: Subjects were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the subject’s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician’s response was recorded using a 100 mm VAS ranging from 0-100(no pain-most severe pain), where higher scores=more disease activity. ITT Population. Here, "Number of Subjects Analyzed"=subjects evaluable for this outcome measure and “n”=subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 30 pre-dose), Week 38, 46 and 54
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    278
    142
    141
    Units: units on a scale
    arithmetic mean (standard deviation)
        PAAP: Baseline; n= 278, 142, 141
    33.137 ± 24.2922
    33.331 ± 22.2738
    32.559 ± 22.2702
        PAAP: Change at Week 38; n= 277, 141, 141
    -0.014 ± 18.7502
    1.440 ± 14.9902
    -0.705 ± 18.9147
        PAAP: Change at Week 46; n= 269, 138, 133
    -2.230 ± 20.0201
    1.087 ± 21.5811
    2.188 ± 20.7319
        PAAP: Change at Week 54; n= 259, 130, 129
    -1.416 ± 20.7823
    -0.492 ± 20.8000
    1.365 ± 24.8362
        PGA: Baseline; n= 278, 142, 141
    35.104 ± 24.8444
    33.268 ± 22.2621
    34.029 ± 22.7172
        PGA: Change at Week 38; n= 277, 141, 141
    -1.628 ± 19.1471
    1.582 ± 16.0776
    -1.086 ± 17.5787
        PGA: Change at Week 46; n= 269, 138, 133
    -3.171 ± 20.3050
    0.558 ± 20.6610
    0.535 ± 21.3947
        PGA: Change at Week 54; n= 259, 130, 129
    -2.929 ± 20.9396
    -0.538 ± 21.1331
    0.776 ± 23.8743
        PGAA: Baseline; n= 278, 142, 141
    25.124 ± 19.0943
    27.294 ± 18.8148
    26.091 ± 17.9503
        PGAA: Change at Week 38; n= 277, 141, 141
    -1.254 ± 12.4789
    0.588 ± 16.5232
    -1.852 ± 15.4699
        PGAA: Change at Week 46; n= 269, 138, 133
    -2.470 ± 13.9135
    0.625 ± 20.0163
    -0.700 ± 18.8038
        PGAA: Change at Week 54; n= 258, 130, 129
    -2.252 ± 17.0422
    -3.398 ± 20.0381
    -2.969 ± 20.1498
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3

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    End point title
    Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3
    End point description
    PAAP: Subjects assessed the severity of their arthritis pain by using 100 mm VAS ranging from 0-100(no pain-most severe pain):corresponded to the magnitude of their pain, higher scores=more pain. PGA: subjects were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” and response was recorded on 100 mm VAS ranging from 0-100(no pain-most severe pain), where higher scores=worse health condition. PGAA: Subjects were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the subject’s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician’s response was recorded using a 100 mm VAS ranging from 0-100(no pain-most severe pain), where higher scores=more disease activity. ITT Population. Here, "Number of Subjects Analyzed"=subjects evaluable for this outcome measure and “n”=subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 54 pre-dose), Week 62, 70 and 78
    End point values
    Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179
    Number of subjects analysed
    123
    126
    249
    Units: units on a scale
    arithmetic mean (standard deviation)
        PAAP: Baseline; n= 249, 123, 126
    31.659 ± 23.2900
    31.225 ± 22.9366
    30.395 ± 23.7412
        PAAP: Change at Week 62; n= 249, 123, 124
    0.276 ± 12.2744
    -1.790 ± 16.6740
    -0.025 ± 15.8259
        PAAP: Change at Week 70; n= 244, 118, 122
    -0.297 ± 15.4108
    -0.970 ± 16.7170
    -2.948 ± 18.1105
        PAAP: Change at Week 78; n= 238, 116, 118
    -2.900 ± 18.0663
    -3.918 ± 20.9632
    -3.552 ± 18.8760
        PGA: Baseline; n= 249, 123, 126
    31.130 ± 23.3603
    32.710 ± 22.6365
    30.841 ± 23.7807
        PGA: Change at Week 62; n= 249, 123, 124
    1.463 ± 13.6899
    -2.226 ± 15.3415
    0.240 ± 16.2724
        PGA: Change at Week 70; n= 244, 119, 122
    0.101 ± 14.4260
    -2.093 ± 16.2677
    -1.764 ± 18.7038
        PGA: Change at Week 78; n= 239, 115, 118
    -2.339 ± 17.0453
    -3.758 ± 19.5447
    -2.880 ± 19.6643
        PGAA: Baseline; n= 249, 123, 126
    21.780 ± 17.3354
    20.705 ± 16.9587
    21.305 ± 17.6278
        PGAA: Change at Week 62; n= 249, 123, 124
    2.659 ± 14.6314
    -0.499 ± 12.9483
    -0.381 ± 13.6810
        PGAA: Change at Week 70; n= 244, 119, 122
    -1.160 ± 12.7665
    -0.810 ± 15.0274
    -3.217 ± 14.1581
        PGAA: Change at Week 78; n= 239, 116, 118
    0.681 ± 15.0989
    -0.159 ± 17.2024
    -2.217 ± 15.3894
    No statistical analyses for this end point

    Secondary: Change From Baseline in High Sensitivity C-Reactive Protein (hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

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    End point title
    Change From Baseline in High Sensitivity C-Reactive Protein (hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
    End point description
    The ITT Population was defined as all subjects who were randomized to study treatment. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this endpoint and “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
    End point values
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX)
    Number of subjects analysed
    321
    325
    Units: milligram/litres
    arithmetic mean (standard deviation)
        Baseline; n= 321, 325
    25.916 ± 24.3118
    25.366 ± 28.4866
        Change at Week 2; n= 318, 324
    -17.183 ± 20.8107
    -16.140 ± 24.2442
        Change at Week 4; n= 312, 315
    -15.555 ± 19.5227
    -13.407 ± 33.9136
        Change at Week 6; n= 313, 320
    -14.078 ± 20.4984
    -13.247 ± 27.7801
        Change at Week 12; n= 311, 317
    -12.502 ± 23.9435
    -12.525 ± 27.8736
        Change at Week 14; n= 310, 314
    -12.613 ± 23.2548
    -12.392 ± 29.3267
        Change at Week 22; n= 301, 308
    -11.195 ± 24.5225
    -11.422 ± 31.0610
        Change at Week 30; n= 292, 297
    -12.165 ± 25.6612
    -12.390 ± 30.0352
    No statistical analyses for this end point

    Secondary: Change From Baseline in High Sensitivity C-Reactive Protein (hs-CRP) Concentration at Week 38, 46 and 54: Period 2

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    End point title
    Change From Baseline in High Sensitivity C-Reactive Protein (hs-CRP) Concentration at Week 38, 46 and 54: Period 2
    End point description
    The ITT Population was defined as all subjects who were randomized to study treatment. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this endpoint and “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 30 pre-dose), Week 38, 46 and 54
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    278
    142
    141
    Units: milligrams/litres
    arithmetic mean (standard deviation)
        Baseline; n= 278, 142, 141
    12.970 ± 19.1927
    14.427 ± 21.1595
    10.847 ± 14.8018
        Change at Week 38; n= 276, 141, 140
    0.496 ± 18.7859
    1.805 ± 19.5138
    0.093 ± 14.8441
        Change at Week 46; n= 266, 138, 133
    1.210 ± 16.1727
    3.996 ± 24.4986
    0.798 ± 15.7687
        Change at Week 54; n= 256, 129, 128
    0.639 ± 21.1226
    2.988 ± 24.5492
    1.264 ± 13.6788
    No statistical analyses for this end point

    Secondary: Change From Baseline in High Sensitivity C-Reactive Protein (hs-CRP) Concentration at Week 62, 70 and 78: Period 3

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    End point title
    Change From Baseline in High Sensitivity C-Reactive Protein (hs-CRP) Concentration at Week 62, 70 and 78: Period 3
    End point description
    The ITT population included all subjects enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Subjects Analyzed" signifies subjects who were evaluable for this endpoint and “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 54 pre-dose), Week 62, 70 and 78
    End point values
    Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179
    Number of subjects analysed
    126
    126
    253
    Units: milligrams/litres
    arithmetic mean (standard deviation)
        Baseline; n= 249, 123, 126
    16.096 ± 24.1595
    11.985 ± 13.8159
    13.112 ± 21.3781
        Change at Week 62; n= 249, 123, 124
    -3.648 ± 21.6177
    -0.541 ± 9.3198
    -0.635 ± 19.9660
        Change at Week 70; n= 244, 119, 121
    -4.199 ± 22.3368
    -0.339 ± 11.7095
    -0.320 ± 23.1234
        Change at Week 78; n= 239, 115, 118
    -3.565 ± 23.9800
    0.811 ± 14.7061
    -1.660 ± 19.6340
    No statistical analyses for this end point

    Secondary: Number of Subjects With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1

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    End point title
    Number of Subjects With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1
    End point description
    ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received. Here “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 30
    End point values
    Period 1: Infliximab-EU Remicade (INX) Period 1: PF-06438179
    Number of subjects analysed
    326
    323
    Units: subjects
        ADA; n= 323, 326
    167
    157
        NAb; n= 157, 167
    143
    124
    No statistical analyses for this end point

    Secondary: Number of Subjects With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2

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    End point title
    Number of Subjects With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2
    End point description
    ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received. Here “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 30 pre-dose) up to Week 54
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    280
    143
    143
    Units: subjects
        ADA; n= 323, 326
    146
    86
    83
        NAb; n= 146, 86, 83
    118
    73
    65
    No statistical analyses for this end point

    Secondary: Number of Subjects With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3

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    End point title
    Number of Subjects With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3
    End point description
    ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70. Safety population was defined as all subjects who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received. Here “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 54 pre-dose) up to Week 78
    End point values
    Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179
    Number of subjects analysed
    126
    126
    253
    Units: subjects
        ADA; n= 323, 326
    66
    72
    119
        NAb; n= 119, 66, 72
    58
    60
    105
    No statistical analyses for this end point

    Secondary: Serum Concentration Versus Time Summary: Period 1

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    End point title
    Serum Concentration Versus Time Summary: Period 1
    End point description
    Pharmacokinetic population: all treated subjects from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all subjects who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations. Here “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29
    End point values
    Period 1: Infliximab-EU Remicade (INX) Period 1: PF-06438179
    Number of subjects analysed
    326
    323
    Units: nanograms/milliliters
    median (standard deviation)
        Day 1: 0 hours; n= 322, 323
    656.2 ± 6583.8
    1635 ± 11163
        Day 1: 2 hours; n= 319, 322
    62220 ± 22129
    65310 ± 24920
        Day 15: 0 hours; n= 316, 323
    16690 ± 8002.7
    17350 ± 8391.4
        Day 29: 336 hours; n= 308, 314
    21570 ± 10986
    23640 ± 12357
        Day 43: 0 hours; n= 308, 315
    10100 ± 7721.7
    11440 ± 10101
        Day 99: 0 hours; n= 302, 310
    2559 ± 6360.3
    3547 ± 9559.2
        Day 99: 2 hours; n= 297, 299
    73350 ± 41410
    76030 ± 39407
        Day 155: 0 hours; n= 295, 303
    1566 ± 2321.4
    2051 ± 3440.9
        Day 211: 0 hours; n= 281, 290
    2112 ± 11703
    1781 ± 2765.2
    No statistical analyses for this end point

    Secondary: Serum Concentration Versus Time Summary: Period 2

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    End point title
    Serum Concentration Versus Time Summary: Period 2
    End point description
    Pharmacokinetic population: all treated subjects from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all subjects who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations. Here “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Pre dose on Day 211, 267, 379 and 547
    End point values
    Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179
    Number of subjects analysed
    280
    143
    143
    Units: nanograms/milliliters
    arithmetic mean (standard deviation)
        Day 211: 0 hours; n= 278, 143, 142
    1801 ± 2773.4
    1083 ± 1763.6
    1819 ± 2393.5
        Day 267: 0 hours; n= 272, 136, 133
    1855 ± 2871.7
    1208 ± 1926.5
    1620 ± 2413.7
        Day 379: 0 hours; n= 248, 125, 125
    2075 ± 4054.6
    1823 ± 6110.8
    1734 ± 2725.2
        Day 547: 0 hours; n= 16, 14, 11
    499.6 ± 1373.0
    212.7 ± 405.18
    3305 ± 8429.5
    No statistical analyses for this end point

    Secondary: Serum Concentration Versus Time Summary: Period 3

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    End point title
    Serum Concentration Versus Time Summary: Period 3
    End point description
    Pharmacokinetic population: all treated subjects from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all subjects who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations. Here “n” signifies subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Pre dose on Day 379, 435 and 547
    End point values
    Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179
    Number of subjects analysed
    126
    126
    253
    Units: nanograms/milliliters
    arithmetic mean (standard deviation)
        Day 379: 0 hours; n= 250, 125, 125
    1823 ± 6110.8
    1734 ± 2725.2
    2078 ± 4044.0
        Day 435: 0 hours; n= 243, 118, 123
    1388 ± 2387.4
    1572 ± 2543.4
    1913 ± 2838.0
        Day 547: 0 hours; n= 243, 121, 119
    1663 ± 5305.7
    1482 ± 2441.6
    1707 ± 2512.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78
    Adverse event reporting additional description
    Safety population: all subjects who are randomized and receive at least 1 dose of study drug, analyzed by actual treatment received. Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be serious in 1 and non-serious in other subject, or 1 subject may experience both serious and non-serious event.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0; 20.0
    Reporting groups
    Reporting group title
    Period 1: PF-06438179
    Reporting group description
    Subjects were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.

    Reporting group title
    Period 1: Infliximab-EU Remicade (INX)
    Reporting group description
    Subjects were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For subjects who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.

    Reporting group title
    Period 2: PF-06438179/PF-06438179
    Reporting group description
    Subjects randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Reporting group title
    Period 2: INX/INX
    Reporting group description
    Subjects randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Reporting group title
    Period 2: INX/PF-06438179
    Reporting group description
    Subjects randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.

    Reporting group title
    Period 3: PF-06438179/PF-06438179/PF-06438179
    Reporting group description
    Subjects received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Reporting group title
    Period 3: INX/INX/PF-06438179
    Reporting group description
    Subjects received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Reporting group title
    Period 3: INX/PF-06438179/PF-06438179
    Reporting group description
    Subjects received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.

    Serious adverse events
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX) Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 323 (4.95%)
    20 / 326 (6.13%)
    13 / 280 (4.64%)
    11 / 143 (7.69%)
    4 / 143 (2.80%)
    3 / 253 (1.19%)
    3 / 126 (2.38%)
    6 / 126 (4.76%)
         number of deaths (all causes)
    1
    1
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Shock
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ocular lymphoma
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    1 / 143 (0.70%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    1 / 253 (0.40%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 323 (0.62%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multi-organ disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Genital prolapse
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    1 / 143 (0.70%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Menometrorrhagia
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cartilage injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    1 / 143 (0.70%)
    0 / 253 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    1 / 253 (0.40%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 323 (0.62%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    2 / 326 (0.61%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    1 / 253 (0.40%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood disorder
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Keratitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticular perforation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    2 / 143 (1.40%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 323 (0.62%)
    2 / 326 (0.61%)
    0 / 280 (0.00%)
    1 / 143 (0.70%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Purulent synovitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 323 (0.31%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 326 (0.31%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    1 / 143 (0.70%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    1 / 280 (0.36%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone abscess
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 326 (0.00%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Period 1: PF-06438179 Period 1: Infliximab-EU Remicade (INX) Period 2: PF-06438179/PF-06438179 Period 2: INX/INX Period 2: INX/PF-06438179 Period 3: PF-06438179/PF-06438179/PF-06438179 Period 3: INX/INX/PF-06438179 Period 3: INX/PF-06438179/PF-06438179
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 323 (11.76%)
    35 / 326 (10.74%)
    8 / 280 (2.86%)
    11 / 143 (7.69%)
    6 / 143 (4.20%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    Injury, poisoning and procedural complications
    Infusion related reaction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    19 / 323 (5.88%)
    21 / 326 (6.44%)
    8 / 280 (2.86%)
    11 / 143 (7.69%)
    6 / 143 (4.20%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    21
    28
    9
    15
    11
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    19 / 323 (5.88%)
    15 / 326 (4.60%)
    0 / 280 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 253 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    20
    21
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Sep 2014
    Protocol Amendment 1
    04 Feb 2015
    Protocol Amendment 2

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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