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    Clinical Trial Results:
    A Randomized, Double-blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis

    Summary
    EudraCT number
    2014-004704-29
    Trial protocol
    CZ   ES   HU   DE   BG   PL  
    Global end of trial date
    13 Aug 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Aug 2019
    First version publication date
    24 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20140111
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02937701
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    13 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the efficacy of ABP 710 compared with US-licensed infliximab.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) regulations and guidelines regarding Good Clinical Practice (GCP), clinical safety data management, and scientific integrity; with United States (US) Food and Drug Administration (FDA) regulations set forth in 21 Code of Federal Regulations Parts 50, 56, and 312; and with European Union (EU) Community Directives 2001/20, 2001/83, 2003/94, and 2005/28 as enacted into local law. Prior to initiation at each study center, the study protocol was reviewed by an Institutional Review Board (IRB) or Institutional Ethics Committee (IEC). All subjects were to provide written informed consent prior to entering the study and before initiation of any study-related procedure (including administration of investigational product). The investigator was responsible for explaining the benefits and risks of participation in the study to each subject or the subject’s legally acceptable representative and for obtaining written informed consent.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Oct 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 258
    Country: Number of subjects enrolled
    Czech Republic: 101
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Bulgaria: 25
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    United States: 104
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Australia: 9
    Worldwide total number of subjects
    558
    EEA total number of subjects
    442
    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)
    434
    From 65 to 84 years
    124
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 75 centers in Australia, Bulgaria, Canada, Czech Republic, Germany, Hungary, Poland, Spain, and the United States.

    Pre-assignment
    Screening details
    Participants were randomized in a 1:1 ratio to receive ABP 710 or infliximab, stratified by geographic region and prior biologic use. At week 22 participants initially randomized to infliximab were re-randomized in a 1:1 ratio to continue infliximab or switch to ABP 710. Participants initially randomized to ABP 710 continued receiving ABP 710.

    Period 1
    Period 1 title
    Day 1 to Week 22
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ABP 710
    Arm description
    Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
    Arm type
    Experimental

    Investigational medicinal product name
    ABP 710
    Investigational medicinal product code
    ABP 710
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3-mg/kg IV infusion on day 1 (week 0), at weeks 2 and 6, and every 8 weeks thereafter.

    Arm title
    Infliximab
    Arm description
    Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
    Arm type
    Active comparator

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Remicade®
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3-mg/kg IV infusion on day 1 (week 0), at weeks 2 and 6, and every 8 weeks thereafter.

    Number of subjects in period 1
    ABP 710 Infliximab
    Started
    279
    279
    Received Treatment
    278
    278
    Completed
    244
    240
    Not completed
    35
    39
         Protocol deviation
    1
    1
         Other
    1
    -
         Physician decision
    2
    -
         Dissatisfied with Treatment Efficacy
    5
    9
         Adverse event, serious fatal
    1
    1
         Adverse event, non-fatal
    11
    14
         Consent withdrawn by subject
    6
    6
         Lost to follow-up
    1
    1
         Protocol Specified Criteria
    7
    7
    Period 2
    Period 2 title
    Week 22 to Week 50
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ABP 710 / ABP 710
    Arm description
    At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.
    Arm type
    Experimental

    Investigational medicinal product name
    ABP 710
    Investigational medicinal product code
    ABP 710
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3-mg/kg IV infusion administered every 8 weeks

    Arm title
    Infliximab / Infliximab
    Arm description
    At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.
    Arm type
    Active comparator

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Remicade®
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3-mg/kg IV infusion administered every 8 weeks

    Arm title
    Infliximab / ABP 710
    Arm description
    At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
    Arm type
    Experimental

    Investigational medicinal product name
    ABP 710
    Investigational medicinal product code
    ABP 710
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3-mg/kg IV infusion administered every 8 weeks

    Number of subjects in period 2
    ABP 710 / ABP 710 Infliximab / Infliximab Infliximab / ABP 710
    Started
    244
    121
    119
    Completed
    212
    113
    110
    Not completed
    32
    8
    9
         Other
    -
    -
    1
         Physician decision
    2
    -
    1
         Dissatisfied with Treatment Efficacy
    10
    3
    2
         Adverse event, non-fatal
    10
    3
    3
         Consent withdrawn by subject
    8
    2
    1
         Lost to follow-up
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABP 710
    Reporting group description
    Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.

    Reporting group title
    Infliximab
    Reporting group description
    Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.

    Reporting group values
    ABP 710 Infliximab Total
    Number of subjects
    279 279 558
    Age, Customized
    Units: Subjects
        < 65 years
    217 217 434
        ≥ 65 years
    62 62 124
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    55.0 ± 11.72 54.8 ± 11.42 -
    Sex: Female, Male
    Units: Subjects
        Female
    214 223 437
        Male
    65 56 121
    Race/Ethnicity, Customized
    Units: Subjects
        White
    265 267 532
        Black or African American
    12 12 24
        Asian
    2 0 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    18 13 31
        Not Hispanic or Latino
    261 266 527
        Unknown or Not Reported
    0 0 0
    Geographic Region
    Units: Subjects
        Asia Pacific
    5 4 9
        Europe
    220 222 442
        North America
    54 53 107
    Prior Biologic Use for Rheumatoid Arthritis
    Units: Subjects
        Yes
    77 81 158
        No
    202 198 400
    Duration of Rheumatoid Arthritis (RA)
    Units: years
        arithmetic mean (standard deviation)
    8.72 ± 7.914 8.34 ± 7.604 -
    Swollen joint Count
    A total of 66 joints were scored for presence or absence of swelling.
    Units: joints
        arithmetic mean (standard deviation)
    14.595 ± 8.0507 14.730 ± 8.8315 -
    Tender Joint Count
    A total of 68 joints were scored for presence or absence of tenderness.
    Units: joints
        arithmetic mean (standard deviation)
    23.109 ± 12.1648 23.764 ± 13.3800 -
    Patient Global Health Assessment
    The participant's overall assessment of their disease activity in the past week assessed on a 100 mm visual analog scale (VAS), where 0 mm = No RA activity at all and 100 mm = Worst RA activity imaginable.
    Units: mm
        arithmetic mean (standard deviation)
    65.4 ± 18.13 64.1 ± 20.03 -
    Investigator's Global Health Assessment
    The investigator's assessment of the participant's current disease activity assessed on a 100 mm VAS where 0 mm = no activity at all (symptom-free and no arthritis symptoms) and 100 mm = worst activity imaginable (maximum arthritis disease activity).
    Units: mm
        arithmetic mean (standard deviation)
    64.5 ± 15.88 64.1 ± 15.76 -
    Patient's Assessment of Disease-related Pain
    The participant's assessment of their current level of pain assessed on a 100 mm horizontal VAS, where 0 mm = no pain at all and 100 mm = worst pain imaginable.
    Units: mm
        arithmetic mean (standard deviation)
    63.5 ± 20.30 61.5 ± 21.65 -
    Disability Index of the Health Assessment Questionnaire (HAQ-DI)
    The HAQ-DI is a patient-reported questionnaire consisting of 20 questions in eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.44 ± 0.584 1.42 ± 0.617 -
    C-reactive Protein (CRP) Concentration
    C-reactive protein (CRP) is a protein found in blood. CRP levels rise in response to inflammation.
    Units: mg/L
        arithmetic mean (standard deviation)
    14.26 ± 20.171 14.64 ± 23.117 -

    End points

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    End points reporting groups
    Reporting group title
    ABP 710
    Reporting group description
    Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.

    Reporting group title
    Infliximab
    Reporting group description
    Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
    Reporting group title
    ABP 710 / ABP 710
    Reporting group description
    At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.

    Reporting group title
    Infliximab / Infliximab
    Reporting group description
    At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.

    Reporting group title
    Infliximab / ABP 710
    Reporting group description
    At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.

    Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22

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    End point title
    Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22
    End point description
    The primary efficacy endpoint was the response difference (RD) of 20% improvement in ACR core set measurements (ACR20) at week 22. A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global health assessment (measured on a 100 mm VAS); ◦ Investigator's global health assessment (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein concentration. The analysis was conducted in the intent-to-treat population which consisted of all randomized participants. Participants with missing data were counted as non-responders (non-responder imputation).
    End point type
    Primary
    End point timeframe
    Baseline and week 22
    End point values
    ABP 710 Infliximab
    Number of subjects analysed
    279
    279
    Units: percentage of participants
        number (confidence interval 95%)
    68.1 (62.63 to 73.57)
    59.1 (53.37 to 64.91)
    Statistical analysis title
    Primary Analysis of ACR20 at Week 22
    Statistical analysis description
    For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [1]
    Method
    Parameter type
    Response Difference
    Point estimate
    9.37
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    2.67
         upper limit
    15.96
    Notes
    [1] - Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).
    Statistical analysis title
    Sensitivity Analysis of ACR20 at Week 22
    Statistical analysis description
    A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [2]
    Method
    Parameter type
    Response Difference
    Point estimate
    9.3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    2.67
         upper limit
    15.92
    Notes
    [2] - Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).
    Statistical analysis title
    Post-hoc Analysis of ACR20 at Week 22
    Statistical analysis description
    A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [3]
    Method
    Parameter type
    Response Difference
    Point estimate
    7.184
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.748
         upper limit
    13.62
    Notes
    [3] - Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).

    Secondary: Percentage of Participants With an ACR20 Response Through Week 14

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    End point title
    Percentage of Participants With an ACR20 Response Through Week 14
    End point description
    A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global health assessment (measured on a 100 mm VAS); ◦ Investigator's global health assessment (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein concentration. The analysis was conducted using the intent-to-treat population; participants with missing data at a given time point were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 6, and 14
    End point values
    ABP 710 Infliximab
    Number of subjects analysed
    279
    279
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    46.2 (40.39 to 52.09)
    38.0 (32.30 to 43.69)
        Week 6
    64.9 (59.27 to 70.48)
    59.9 (54.10 to 65.61)
        Week 14
    66.3 (60.76 to 71.85)
    60.2 (54.47 to 65.96)
    Statistical analysis title
    Response Difference at Week 2
    Statistical analysis description
    The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    8.03
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    1.15
         upper limit
    14.81
    Statistical analysis title
    Response Difference at Week 14
    Statistical analysis description
    The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    Response Difference
    Point estimate
    9.37
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.51
         upper limit
    12.87
    Statistical analysis title
    Response Difference at Week 6
    Statistical analysis description
    The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    4.96
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.8
         upper limit
    11.64

    Secondary: Percentage of Participants With an ACR20 Response After Week 22

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    End point title
    Percentage of Participants With an ACR20 Response After Week 22
    End point description
    A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global health assessment (measured on a 100 mm VAS); ◦ Investigator's global health assessment (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein concentration. The analysis was conducted in participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 30, 34, 38, 46, and 50
    End point values
    ABP 710 / ABP 710 Infliximab / Infliximab Infliximab / ABP 710
    Number of subjects analysed
    244
    121
    119
    Units: percentage of participants
    number (confidence interval 95%)
        Week 30
    69.7 (63.90 to 75.44)
    66.9 (58.56 to 75.32)
    74.8 (66.99 to 82.59)
        Week 34
    74.6 (69.13 to 80.05)
    71.1 (63.00 to 79.15)
    74.8 (66.99 to 82.59)
        Week 38
    70.5 (64.77 to 76.21)
    69.4 (61.21 to 77.63)
    72.3 (64.23 to 80.31)
        Week 46
    61.9 (55.79 to 67.98)
    65.3 (56.81 to 73.77)
    66.4 (57.90 to 74.87)
        Week 50
    67.6 (61.75 to 73.49)
    72.7 (64.79 to 80.66)
    70.6 (62.40 to 78.77)
    Statistical analysis title
    Response Difference at Week 30
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    3.05
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.26
         upper limit
    11.73
    Statistical analysis title
    Response Difference at Week 30
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    8.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.18
         upper limit
    17.97
    Statistical analysis title
    Response Difference at Week 34
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    3.31
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.61
         upper limit
    11.7
    Statistical analysis title
    Response Difference at Week 34
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    4.06
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.4
         upper limit
    13.4
    Statistical analysis title
    Response Difference at Week 38
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    0.82
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.34
         upper limit
    9.4
    Statistical analysis title
    Response Difference at Week 38
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    2.79
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.86
         upper limit
    12.34
    Statistical analysis title
    Response Difference at Week 46
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -3.74
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -12.27
         upper limit
    5.17
    Statistical analysis title
    Response Difference at Week 46
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    1.12
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.89
         upper limit
    11.08
    Statistical analysis title
    Response Difference at Week 50
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Response Difference
    Point estimate
    -5.25
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -13.24
         upper limit
    3.29
    Statistical analysis title
    Response Difference at Week 50
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -1.49
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -11.01
         upper limit
    8.04

    Secondary: Percentage of Participants With an ACR50 Response Through Week 22

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    End point title
    Percentage of Participants With an ACR50 Response Through Week 22
    End point description
    A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 50% improvement in 68 tender joint count; • ≥ 50% improvement in 66 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global health assessment (measured on a 100 mm VAS); ◦ Investigator's global health assessment (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein concentration. The analysis was conducted in the intent-to-treat population; participants with missing data at a given time point were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 6, 14, and 22
    End point values
    ABP 710 Infliximab
    Number of subjects analysed
    279
    279
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    17.2 (12.78 to 21.63)
    12.5 (8.66 to 16.43)
        Week 6
    30.1 (24.72 to 35.49)
    28.3 (23.03 to 33.60)
        Week 14
    39.4 (33.69 to 45.16)
    36.9 (31.25 to 42.58)
        Week 22
    43.0 (37.20 to 48.82)
    36.2 (30.56 to 41.84)
    Statistical analysis title
    Response Difference at Week 2
    Statistical analysis description
    The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    4.41
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.56
         upper limit
    9.38
    Statistical analysis title
    Response Difference at Week 6
    Statistical analysis description
    The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    1.62
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.71
         upper limit
    7.94
    Statistical analysis title
    Response Difference at Week 14
    Statistical analysis description
    The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    2.3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.45
         upper limit
    9.03
    Statistical analysis title
    Response Difference at Week 22
    Statistical analysis description
    The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    7.09
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.27
         upper limit
    13.83

    Secondary: Percentage of Participants With an ACR50 Response After Week 22

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    End point title
    Percentage of Participants With an ACR50 Response After Week 22
    End point description
    A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 50% improvement in 68 tender joint count; • ≥ 50% improvement in 66 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global health assessment (measured on a 100 mm VAS); ◦ Investigator's global health assessment (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein concentration. The analysis was conducted in participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 30, 34, 38, 46, and 50
    End point values
    ABP 710 / ABP 710 Infliximab / Infliximab Infliximab / ABP 710
    Number of subjects analysed
    244
    121
    119
    Units: percentage of participants
    number (confidence interval 95%)
        Week 30
    43.0 (36.82 to 49.25)
    44.6 (35.77 to 53.49)
    47.1 (38.09 to 56.03)
        Week 34
    52.5 (46.19 to 58.73)
    46.3 (37.40 to 55.17)
    56.3 (47.39 to 65.21)
        Week 38
    48.0 (41.68 to 54.22)
    47.1 (38.21 to 56.00)
    49.6 (40.60 to 58.56)
        Week 46
    43.9 (37.63 to 50.08)
    44.6 (35.77 to 53.49)
    50.4 (41.44 to 59.40)
        Week 50
    49.2 (42.91 to 55.45)
    54.5 (45.67 to 63.42)
    57.1 (48.25 to 66.03)
    Statistical analysis title
    Response Difference at Week 30
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -1.33
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -10.4
         upper limit
    7.62
    Statistical analysis title
    Response Difference at Week 30
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    3.24
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.28
         upper limit
    13.67
    Statistical analysis title
    Response Difference at Week 34
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    6.52
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.62
         upper limit
    15.48
    Statistical analysis title
    Response Difference at Week 34
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    10.74
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.12
         upper limit
    21.03
    Statistical analysis title
    Response Difference at Week 38
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    0.56
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.54
         upper limit
    9.59
    Statistical analysis title
    Response Difference at Week 38
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    2.93
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.62
         upper limit
    13.39
    Statistical analysis title
    Response Difference at Week 46
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -1.04
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -10.11
         upper limit
    7.93
    Statistical analysis title
    Response Difference at Week 46
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    6.14
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.44
         upper limit
    16.54
    Statistical analysis title
    Response Difference at Week 50
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -5.43
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -14.39
         upper limit
    3.71
    Statistical analysis title
    Response Difference at Week 50
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    2.98
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.51
         upper limit
    13.37

    Secondary: Percentage of Participants With an ACR70 Response Through Week 22

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    End point title
    Percentage of Participants With an ACR70 Response Through Week 22
    End point description
    A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 70% improvement in 68 tender joint count; • ≥ 70% improvement in 66 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global health assessment (measured on a 100 mm VAS); ◦ Investigator's global health assessment (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein concentration. The analysis was conducted in the intent-to-treat population; participants with missing data at a given visit were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 6, 14, and 22
    End point values
    ABP 710 Infliximab
    Number of subjects analysed
    279
    279
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    3.9 (1.66 to 6.23)
    6.5 (3.57 to 9.33)
        Week 6
    14.3 (10.22 to 18.45)
    16.5 (12.13 to 20.84)
        Week 14
    21.9 (17.01 to 26.71)
    16.1 (11.81 to 20.44)
        Week 22
    24.0 (19.00 to 29.03)
    19.7 (15.05 to 24.38)
    Statistical analysis title
    Response Difference at Week 2
    Statistical analysis description
    The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -2.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.84
         upper limit
    0.83
    Statistical analysis title
    Response Difference at Week 6
    Statistical analysis description
    The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -2.43
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.47
         upper limit
    2.64
    Statistical analysis title
    Response Difference at Week 14
    Statistical analysis description
    The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    5.46
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    10.91
    Statistical analysis title
    Response Difference at Week 22
    Statistical analysis description
    The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    4.58
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.21
         upper limit
    10.34

    Secondary: Percentage of Participants With an ACR70 Response After Week 22

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    End point title
    Percentage of Participants With an ACR70 Response After Week 22
    End point description
    A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 70% improvement in 68 tender joint count; • ≥ 70% improvement in 66 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global health assessment (measured on a 100 mm VAS); ◦ Investigator's global health assessment (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein concentration. The analysis was conducted in participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 30, 34, 38, 46, and 50
    End point values
    ABP 710 / ABP 710 Infliximab / Infliximab Infliximab / ABP 710
    Number of subjects analysed
    244
    121
    119
    Units: percentage of participants
    number (confidence interval 95%)
        Week 30
    26.6 (21.09 to 32.19)
    26.4 (18.59 to 34.30)
    26.1 (18.16 to 33.94)
        Week 34
    29.5 (23.79 to 35.23)
    28.1 (20.09 to 36.11)
    35.3 (26.71 to 43.88)
        Week 38
    29.1 (23.40 to 34.80)
    29.8 (21.61 to 37.90)
    32.8 (24.34 to 41.21)
        Week 46
    29.5 (23.79 to 35.23)
    29.8 (21.61 to 37.90)
    37.0 (28.30 to 45.65)
        Week 50
    34.0 (28.07 to 39.96)
    32.2 (23.90 to 40.56)
    43.7 (34.79 to 52.61)
    Statistical analysis title
    Response Difference at Week 30
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    0.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.12
         upper limit
    8.02
    Statistical analysis title
    Response Difference at Week 30
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -0.08
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.39
         upper limit
    9.28
    Statistical analysis title
    Response Difference at Week 34
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    1.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7
         upper limit
    9.51
    Statistical analysis title
    Response Difference at Week 34
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    7.49
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.39
         upper limit
    17.22
    Statistical analysis title
    Response Difference at Week 38
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -0.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.03
         upper limit
    7.59
    Statistical analysis title
    Response Difference at Week 38
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    3.39
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.41
         upper limit
    13.14
    Statistical analysis title
    Response Difference at Week 46
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    -0.43
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.98
         upper limit
    7.66
    Statistical analysis title
    Response Difference at Week 46
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    7.87
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.13
         upper limit
    17.68
    Statistical analysis title
    Response Difference at Week 50
    Statistical analysis description
    The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    1.95
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.81
         upper limit
    10.29
    Statistical analysis title
    Response Difference at Week 50
    Statistical analysis description
    The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Response Difference
    Point estimate
    12.06
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    1.74
         upper limit
    22.04

    Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) Through Week 22

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    End point title
    Change from Baseline in Disease Activity Score 28 (DAS28) Through Week 22
    End point description
    The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count • C-reactive protein (CRP) • Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. The analysis was conducted in the intent-to-treat population with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 6, 14, and 22
    End point values
    ABP 710 Infliximab
    Number of subjects analysed
    279
    279
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 2 (N = 260, 255)
    -1.36 ± 0.991
    -1.29 ± 1.006
        Week 6 (N = 259,253)
    -1.82 ± 1.222
    -1.82 ± 1.203
        Week 14 (N = 253, 250)
    -1.95 ± 1.218
    -1.91 ± 1.289
        Week 22 (N = 245, 243)
    -2.06 ± 1.290
    -2.06 ± 1.296
    Statistical analysis title
    Mean Difference at Week 2
    Statistical analysis description
    Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    -0.07
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    0.007
    Statistical analysis title
    Mean Difference at Week 6
    Statistical analysis description
    Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    0
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.17
         upper limit
    0.16
    Statistical analysis title
    Mean Difference at Week 14
    Statistical analysis description
    Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    -0.04
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.21
         upper limit
    0.14
    Statistical analysis title
    Mean Difference at Week 22
    Statistical analysis description
    Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 v Infliximab
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    -0.01
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    0.17

    Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) After Week 22

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    End point title
    Change from Baseline in Disease Activity Score 28 (DAS28) After Week 22
    End point description
    The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count • C-reactive protein (CRP) • Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. The analysis was conducted in participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22) with available data.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 30, 34, 38, 46, and 50
    End point values
    ABP 710 / ABP 710 Infliximab / Infliximab Infliximab / ABP 710
    Number of subjects analysed
    244
    121
    119
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 30 (N = 225, 112, 112)
    -2.07 ± 1.278
    -2.25 ± 1.379
    -2.22 ± 1.266
        Week 34 (N = 222, 113, 111)
    -2.32 ± 1.306
    -2.46 ± 1.372
    -2.45 ± 1.309
        Week 38 (N = 219, 114, 110)
    -2.20 ± 1.277
    -2.27 ± 1.301
    -2.32 ± 1.400
        Week 46 (N = 205, 108, 108)
    -2.11 ± 1.381
    -2.27 ± 1.387
    -2.26 ± 1.440
        Week 50 (N = 203, 110, 107)
    -2.45 ± 1.365
    -2.49 ± 1.276
    -2.64 ± 1.328
    Statistical analysis title
    Mean Difference at Week 30
    Statistical analysis description
    Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    0.16
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.08
         upper limit
    0.4
    Statistical analysis title
    Mean Difference at Week 30
    Statistical analysis description
    Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    0
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.27
         upper limit
    0.28
    Statistical analysis title
    Mean Difference at Week 34
    Statistical analysis description
    Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    0.11
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.12
         upper limit
    0.35
    Statistical analysis title
    Mean Difference at Week 34
    Statistical analysis description
    Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    -0.03
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    0.24
    Statistical analysis title
    Mean Difference at Week 38
    Statistical analysis description
    Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    0.06
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.18
         upper limit
    0.3
    Statistical analysis title
    Mean Difference at Week 38
    Statistical analysis description
    Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    -0.08
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.36
         upper limit
    0.2
    Statistical analysis title
    Mean Difference at Week 46
    Statistical analysis description
    Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    0.11
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.14
         upper limit
    0.37
    Statistical analysis title
    Mean Difference at Week 46
    Statistical analysis description
    Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    -0.05
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.34
         upper limit
    0.25
    Statistical analysis title
    Mean Difference at Week 50
    Statistical analysis description
    Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    ABP 710 / ABP 710 v Infliximab / Infliximab
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    0
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.24
         upper limit
    0.24
    Statistical analysis title
    Mean Difference at Week 50
    Statistical analysis description
    Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
    Comparison groups
    Infliximab / Infliximab v Infliximab / ABP 710
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.47
         upper limit
    0.08

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to week 22 (initial ABP 710 and infliximab treatment groups) and from week 22 to week 50 for participants re-randomized at week 22, or up to 28 days after last dose for participants who discontinued early.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    ABP 710
    Reporting group description
    Participants received 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.

    Reporting group title
    Infliximab
    Reporting group description
    Participants received 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.

    Reporting group title
    ABP 710 / ABP 710
    Reporting group description
    At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.

    Reporting group title
    Infliximab / Infliximab
    Reporting group description
    At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.

    Reporting group title
    Infliximab / ABP 710
    Reporting group description
    At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.

    Serious adverse events
    ABP 710 Infliximab ABP 710 / ABP 710 Infliximab / Infliximab Infliximab / ABP 710
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 278 (3.24%)
    14 / 278 (5.04%)
    15 / 241 (6.22%)
    4 / 121 (3.31%)
    1 / 119 (0.84%)
         number of deaths (all causes)
    1
    1
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Peripheral ischaemia
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Thrombosis
         subjects affected / exposed
    0 / 278 (0.00%)
    2 / 278 (0.72%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Malignant melanoma
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Ovarian low malignant potential tumour
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Hip fracture
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Laceration
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Multiple injuries
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Investigations
    Transaminases increased
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiac failure congestive
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Myocardial infarction
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    1 / 121 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    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
    Microcytic anaemia
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Transient ischaemic attack
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Constipation
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Pancreatitis acute
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    1 / 121 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Jaundice cholestatic
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    1 / 121 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal failure
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Ureterolithiasis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    1 / 121 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    1 / 121 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Foot deformity
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    2 / 241 (0.83%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Arthritis bacterial
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Cellulitis
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    2 / 241 (0.83%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastroenteritis
         subjects affected / exposed
    0 / 278 (0.00%)
    0 / 278 (0.00%)
    1 / 241 (0.41%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia bacterial
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 278 (0.00%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 278 (0.36%)
    0 / 241 (0.00%)
    0 / 121 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    ABP 710 Infliximab ABP 710 / ABP 710 Infliximab / Infliximab Infliximab / ABP 710
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 278 (17.27%)
    32 / 278 (11.51%)
    52 / 241 (21.58%)
    28 / 121 (23.14%)
    30 / 119 (25.21%)
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    14 / 278 (5.04%)
    11 / 278 (3.96%)
    23 / 241 (9.54%)
    9 / 121 (7.44%)
    7 / 119 (5.88%)
         occurrences all number
    14
    11
    23
    10
    9
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 278 (4.32%)
    4 / 278 (1.44%)
    13 / 241 (5.39%)
    11 / 121 (9.09%)
    8 / 119 (6.72%)
         occurrences all number
    12
    4
    13
    12
    10
    Pharyngitis
         subjects affected / exposed
    8 / 278 (2.88%)
    3 / 278 (1.08%)
    2 / 241 (0.83%)
    2 / 121 (1.65%)
    7 / 119 (5.88%)
         occurrences all number
    8
    3
    2
    2
    7
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 278 (6.12%)
    18 / 278 (6.47%)
    23 / 241 (9.54%)
    9 / 121 (7.44%)
    14 / 119 (11.76%)
         occurrences all number
    18
    18
    26
    9
    16

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2017
    - Clarified the premedication requirement. - Specified that subjects who were unable to complete the week 22 visit within the allowed window were to be discontinued from the study and that these subjects should return for an EOS visit to complete the EOS assessments within 28 days, if possible. - Specified that subjects who were unable to complete the screening procedures within 28 days before baseline would be considered screen failures. Specified that these subjects could be rescreened, and they may be rescreened under the same informed consent form if rescreening occurred within 30 days. - Removed "adverse events" from the list of examples of "Reasons for removal of a subject from the study." - Emphasized that preinfusion PK samples were required to be drawn within 1 hour before dosing and that end-of-infusion PK samples were required to be collected within 10 minutes of completing the infusion. - Specified that 95% CIs, in addition to 90% CIs, would be presented for efficacy endpoints. - Clarified the inclusion and exclusion criteria.

    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
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