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    Clinical Trial Results:
    A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis

    Summary
    EudraCT number
    2013-005543-90
    Trial protocol
    HU   DE   PL   BG   EE  
    Global end of trial date
    08 Oct 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    20130108
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02792699
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, 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
    08 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate pharmacokinetic (PK) similarity of ABP 798 relative to that of US-licensed rituximab (rituximab [US]) and of EU-authorized rituximab (rituximab [EU]). The secondary objectives were to demonstrate PK similarity between rituximab (US) and rituximab (EU); and to assess the clinical efficacy, safety, and immunogenicity of ABP 798 compared with rituximab.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines, the general principles indicated in the Declaration of Helsinki, and all applicable regulatory requirements. Prior to initiation at each study center, the study protocol was reviewed by an Institutional Review Board (IRB) or Independent 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
    17 May 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: 115
    Country: Number of subjects enrolled
    Bulgaria: 30
    Country: Number of subjects enrolled
    Hungary: 23
    Country: Number of subjects enrolled
    Estonia: 8
    Country: Number of subjects enrolled
    United States: 117
    Country: Number of subjects enrolled
    Germany: 18
    Worldwide total number of subjects
    311
    EEA total number of subjects
    194
    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)
    239
    From 65 to 84 years
    72
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 57 centers in Bulgaria, Estonia, Germany, Hungary, Poland, and the United States (US). Eligible participants were men and women aged 18 to 80 years, inclusive, with a diagnosis of rheumatoid arthritis (RA) for at least 6 months.

    Pre-assignment
    Screening details
    Participants were randomized in a 1:1:1 ratio to 1 of 3 groups, stratified by geographic region (North America vs Eastern Europe vs Western Europe), seropositivity (rheumatoid factor [RF]-positive and/or cyclic citrullinated peptide [CCP]-positive vs RF-negative and CCP-negative), and number of prior biologic therapies used for RA (1 vs > 1).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ABP 798 / ABP 798
    Arm description
    Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
    Arm type
    Experimental

    Investigational medicinal product name
    ABP 798
    Investigational medicinal product code
    ABP 798
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.

    Arm title
    Rituximab (EU) / Rituximab (EU)
    Arm description
    Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
    Arm type
    Active comparator

    Investigational medicinal product name
    Rituximab (EU formulation)
    Investigational medicinal product code
    Other name
    MabThera®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.

    Arm title
    Rituximab (US) / ABP 798
    Arm description
    Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
    Arm type
    Active comparator

    Investigational medicinal product name
    Rituximab (US formulation)
    Investigational medicinal product code
    Other name
    Rituxan®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.

    Investigational medicinal product name
    ABP 798
    Investigational medicinal product code
    ABP 798
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.

    Number of subjects in period 1
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Started
    104
    104
    103
    Received First Infusion of First Dose
    104
    104
    103
    Received Second Infusion of First Dose
    102
    103
    99
    Received First Infusion of Second Dose
    97
    99
    95
    Received Second Infusion of Second Dose
    97
    99
    93
    Completed
    95
    94
    93
    Not completed
    9
    10
    10
         Other
    1
    -
    -
         Physician decision
    2
    -
    -
         Adverse event, non-fatal
    1
    2
    4
         Dissatisfaction with Treatment Efficacy
    1
    3
    1
         Consent withdrawn by subject
    4
    4
    3
         Lost to follow-up
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABP 798 / ABP 798
    Reporting group description
    Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Reporting group title
    Rituximab (EU) / Rituximab (EU)
    Reporting group description
    Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Reporting group title
    Rituximab (US) / ABP 798
    Reporting group description
    Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Reporting group values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798 Total
    Number of subjects
    104 104 103 311
    Age, Customized
    Units: Subjects
        < 65 years
    87 74 78 239
        ≥ 65 years
    17 30 25 72
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    54.6 ± 10.70 56.8 ± 11.34 56.4 ± 10.66 -
    Sex: Female, Male
    Units: Subjects
        Female
    90 91 83 264
        Male
    14 13 20 47
    Race/Ethnicity, Customized
    Units: Subjects
        White
    97 99 91 287
        Black or African American
    5 3 10 18
        Asian
    0 2 1 3
        American Indian or Alaska Native
    2 0 0 2
        Native Hawaiian or other Pacific Islander
    0 0 0 0
        Other
    0 0 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    8 10 11 29
        Not Hispanic or Latino
    96 94 92 282
        Unknown or Not Reported
    0 0 0 0
    Geographic Region
    Units: Subjects
        North America
    38 40 39 117
        Eastern Europe
    59 58 59 176
        Western Europe
    7 6 5 18
    Seropositivity
    Seropositivity defined as rheumatoid factor [RF]-positive and/or cyclic citrullinated peptide [CCP]-positive vs RF-negative and CCP-negative).
    Units: Subjects
        RF positive and/or CCP positive
    86 88 89 263
        RF negative and CCP negative
    18 16 14 48
    Prior Biologic Use for RA
    Units: Subjects
        One
    62 61 63 186
        More than one
    42 43 40 125
    Duration of RA
    Units: years
        arithmetic mean (standard deviation)
    11.37 ± 7.400 11.69 ± 7.945 12.48 ± 9.186 -
    Disease Activity Score 28 – C-Reactive Protein (DAS28[CRP])
    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 visual analog scale. 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.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    6.09 ± 1.035 5.84 ± 1.006 6.03 ± 0.997 -

    End points

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    End points reporting groups
    Reporting group title
    ABP 798 / ABP 798
    Reporting group description
    Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Reporting group title
    Rituximab (EU) / Rituximab (EU)
    Reporting group description
    Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Reporting group title
    Rituximab (US) / ABP 798
    Reporting group description
    Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Subject analysis set title
    ABP 798
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).

    Subject analysis set title
    Rituximab (EU)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).

    Subject analysis set title
    Rituximab (US)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).

    Subject analysis set title
    Rituximab (US + EU)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.

    Primary: Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose

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    End point title
    Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose
    End point description
    Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUCinf was estimated using the linear trapezoidal rule. The analysis includes participants in the pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUCinf data. Participants with unreliable terminal elimination rate constant values were excluded.
    End point type
    Primary
    End point timeframe
    Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    94
    96
    94
    Units: h*µg/mL
        geometric mean (geometric coefficient of variation)
    149398 ± 36.2
    172463 ± 32.9
    158529 ± 34.9
    Statistical analysis title
    PK Similarity Between ABP 798 and Rituximab (US)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (US)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [1]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9569
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.887
         upper limit
    1.0323
    Notes
    [1] - PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity Between ABP 798 and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (EU)
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [2]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.8848
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8204
         upper limit
    0.9542
    Notes
    [2] - PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of Rituximab (US) and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    Rituximab (EU) v Rituximab (US)
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [3]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9246
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8575
         upper limit
    0.997
    Notes
    [3] - PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.

    Primary: Maximum Observed Drug Concentration (Cmax) After the Second Infusion of the First Dose

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    End point title
    Maximum Observed Drug Concentration (Cmax) After the Second Infusion of the First Dose
    End point description
    Maximum observed concentration following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis includes participants in the pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Cmax data on day 15.
    End point type
    Primary
    End point timeframe
    Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    96
    97
    93
    Units: µg/mL
        geometric mean (geometric coefficient of variation)
    361 ± 23.5
    394 ± 22.0
    372 ± 24.7
    Statistical analysis title
    PK Similarity of ABP 798 and Rituximab (US)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (US)
    Number of subjects included in analysis
    189
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [4]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.984
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.9356
         upper limit
    1.0348
    Notes
    [4] - PK similarity between the test (ABP 798) and reference (rituximab [US]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of ABP 798 and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (EU)
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [5]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9368
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8912
         upper limit
    0.9848
    Notes
    [5] - PK similarity between the test (ABP 798) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of Rituximab (US) and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    Rituximab (EU) v Rituximab (US)
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [6]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9521
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.9055
         upper limit
    1.001
    Notes
    [6] - PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.

    Secondary: Area Under the Serum Concentration-time Curve From Predose on Day 1 to 14 days Postdose (AUC0-14day)

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    End point title
    Area Under the Serum Concentration-time Curve From Predose on Day 1 to 14 days Postdose (AUC0-14day)
    End point description
    Area under the serum concentration-time curve from time 0 on day 1 prior to the first infusion of the first dose to 14 days postdose. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUC0-14day was estimated using the linear trapezoidal rule. The analysis includes participants in the pharmacokinetic (PK) parameter analysis set with available AUC0-14day data.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    98
    97
    93
    Units: h*µg/mL
        geometric mean (geometric coefficient of variation)
    41445 ± 28.8
    45161 ± 24.7
    43291 ± 29.6
    Statistical analysis title
    PK Similarity of ABP 798 and Rituximab (US)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (US)
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [7]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9729
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.9174
         upper limit
    1.0318
    Notes
    [7] - PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of ABP 798 and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (EU)
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [8]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9394
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8863
         upper limit
    0.9958
    Notes
    [8] - PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of Rituximab (US) and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    Rituximab (EU) v Rituximab (US)
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [9]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9656
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.9104
         upper limit
    1.024
    Notes
    [9] - PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.

    Secondary: Area Under the Serum Concentration-time Curve From Predose on Day 1 to Week 12 (AUC0-12wk)

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    End point title
    Area Under the Serum Concentration-time Curve From Predose on Day 1 to Week 12 (AUC0-12wk)
    End point description
    Area under the serum concentration-time curve from time 0 on day 1 prior to the first infusion of the first dose to week 12. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUC0-12wk was estimated using the linear trapezoidal rule. The analysis includes participants in the pharmacokinetic (PK) parameter analysis set with available AUC0-12wk data.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hour postdose, and at days 29, 57, and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    99
    100
    96
    Units: h*µg/mL
        geometric mean (geometric coefficient of variation)
    146369 ± 34.3
    166995 ± 30.5
    155240 ± 33.7
    Statistical analysis title
    PK Similarity of ABP 798 and Rituximab (US)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (US)
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [10]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9603
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.895
         upper limit
    1.0303
    Notes
    [10] - PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of ABP 798 and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (EU)
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [11]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.8968
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8363
         upper limit
    0.9616
    Notes
    [11] - PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of Rituximab (US) and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    Rituximab (EU) v Rituximab (US)
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [12]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9339
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8707
         upper limit
    1.0016
    Notes
    [12] - PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.

    Secondary: Maximum Observed Drug Concentration (Cmax) After the First Infusion of the First Dose

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    End point title
    Maximum Observed Drug Concentration (Cmax) After the First Infusion of the First Dose
    End point description
    Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis includes participants in the pharmacokinetic parameter analysis set with available Cmax data.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    103
    103
    99
    Units: µg/mL
        geometric mean (geometric coefficient of variation)
    298 ± 26.1
    321 ± 21.2
    304 ± 25.5
    Statistical analysis title
    PK Similarity of ABP 798 and Rituximab (US)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (US)
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [13]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9942
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.9461
         upper limit
    1.0448
    Notes
    [13] - PK similarity between the test (ABP 798) and reference (rituximab [US]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of ABP 798 and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    ABP 798 v Rituximab (EU)
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [14]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9475
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.9021
         upper limit
    0.9953
    Notes
    [14] - PK similarity between the test (ABP 798) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
    Statistical analysis title
    PK Similarity of Rituximab (US) and Rituximab (EU)
    Statistical analysis description
    The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
    Comparison groups
    Rituximab (EU) v Rituximab (US)
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [15]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    0.9531
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.907
         upper limit
    1.0015
    Notes
    [15] - PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.

    Secondary: Time of Maximum Observed Drug Concentration (Tmax) After the First and Second Infusions of the First Dose

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    End point title
    Time of Maximum Observed Drug Concentration (Tmax) After the First and Second Infusions of the First Dose
    End point description
    Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis included participants in the pharmacokinetic parameter analysis set with available Tmax data at each time point.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    103 [16]
    103 [17]
    99 [18]
    Units: hours
    median (inter-quartile range (Q1-Q3))
        After First Infusion (Day 1)
    4.50 (4.35 to 7.18)
    4.67 (4.38 to 7.30)
    4.68 (4.38 to 7.50)
        After Second Infusion (Day 15)
    3.57 (3.42 to 6.03)
    3.67 (3.40 to 5.50)
    4.12 (3.42 to 6.55)
    Notes
    [16] - N = 96 after second infusion
    [17] - N = 97 after second infusion
    [18] - N = 93 after second infusion
    No statistical analyses for this end point

    Secondary: Last Measurable Serum Concentration After the Second Infusion up to Week 12 (Clast)

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    End point title
    Last Measurable Serum Concentration After the Second Infusion up to Week 12 (Clast)
    End point description
    Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis included participants in the pharmacokinetic parameter analysis set with available Clast data.
    End point type
    Secondary
    End point timeframe
    Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    101
    103
    98
    Units: µg/mL
        geometric mean (geometric coefficient of variation)
    5.95 ± 154
    8.52 ± 145
    6.76 ± 143
    No statistical analyses for this end point

    Secondary: Terminal Elimination Half-life (t1/2)

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    End point title
    Terminal Elimination Half-life (t1/2)
    End point description
    Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis included participants in the pharmacokinetic parameter analysis set with available T1/2 data.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    96
    98
    96
    Units: hours
        geometric mean (geometric coefficient of variation)
    335.62 ± 38
    375.26 ± 32
    334.57 ± 40
    No statistical analyses for this end point

    Secondary: Terminal Elimination Rate Constant (λz)

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    End point title
    Terminal Elimination Rate Constant (λz)
    End point description
    Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis included participants in the pharmacokinetic (PK) parameter analysis set with available λz data.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57 and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    101
    103
    98
    Units: 1/h
        geometric mean (geometric coefficient of variation)
    0.00205 ± 38.61018
    0.00187 ± 33.44044
    0.00205 ± 40.15779
    No statistical analyses for this end point

    Secondary: Clearance (CL)

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    End point title
    Clearance (CL)
    End point description
    Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis included participants in the pharmacokinetic parameter analysis set with available CL data.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    94
    96
    94
    Units: L/h
        geometric mean (geometric coefficient of variation)
    0.01339 ± 36.22558
    0.01160 ± 32.94524
    0.01262 ± 34.93316
    No statistical analyses for this end point

    Secondary: Mean Residence Time (MRT)

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    End point title
    Mean Residence Time (MRT)
    End point description
    Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis included participants in the pharmacokinetic parameter analysis set with available MRT data.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    94
    96
    94
    Units: hours
        geometric mean (geometric coefficient of variation)
    549 ± 26.7
    592 ± 26.5
    557 ± 26.8
    No statistical analyses for this end point

    Secondary: Percent of AUC Extrapolation (AUC%extrap)

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    End point title
    Percent of AUC Extrapolation (AUC%extrap)
    End point description
    Percent of AUC extrapolated to infinity in AUCinf. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis included participants in the pharmacokinetic parameter analysis set with available AUC%extrap data.
    End point type
    Secondary
    End point timeframe
    Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    101
    103
    98
    Units: percent extrapolation
        geometric mean (geometric coefficient of variation)
    1.91 ± 161
    2.62 ± 146
    2.06 ± 148
    No statistical analyses for this end point

    Secondary: AUC0-12 wk/AUCinf

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    End point title
    AUC0-12 wk/AUCinf
    End point description
    Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. The analysis included participants in the pharmacokinetic parameter analysis set with available data.
    End point type
    Secondary
    End point timeframe
    Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    96
    98
    96
    Units: ratio
        geometric mean (geometric coefficient of variation)
    0.97 ± 3
    0.96 ± 4
    0.97 ± 3
    No statistical analyses for this end point

    Secondary: Change from Baseline in Disease Activity Score 28-CRP at Week 24

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    End point title
    Change from Baseline in Disease Activity Score 28-CRP at Week 24
    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 included participants in the full analysis set (all randomized participants) using observed data and a repeated measures analysis in which data from all assessed postbaseline time points were included.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    ABP 798 Rituximab (EU) Rituximab (US) Rituximab (US + EU)
    Number of subjects analysed
    104
    104
    103
    207
    Units: units on a scale
        least squares mean (standard error)
    -2.006 ± 0.1313
    -2.116 ± 0.1339
    -1.936 ± 0.1349
    -2.026 ± 0.1039
    Statistical analysis title
    Clinical Equivalence of ABP 798 and Rituximab
    Statistical analysis description
    If PK similarity was established between rituximab (US) and rituximab (EU), the 2 rituximab arms were to be combined into a single reference group for the primary assessment of clinical equivalence of DAS28-CRP change from baseline at week 24 using a repeated measures analysis with DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and baseline DAS28-CRP as predictors, and unstructured covariance matrix in the model.
    Comparison groups
    ABP 798 v Rituximab (US + EU)
    Number of subjects included in analysis
    311
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [19]
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.02
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.225
         upper limit
    0.264
    Notes
    [19] - Clinical equivalence was tested by comparing the 2-sided 90% CI of the change from baseline at week 24 of DAS28-CRP between ABP 798 and rituximab with an equivalence margin of (-0.6, 0.6).
    Statistical analysis title
    Comparison of ABP 798 and Rituximab (US)
    Comparison groups
    ABP 798 v Rituximab (US)
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -0.07
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.353
         upper limit
    0.213
    Statistical analysis title
    Comparison of ABP 798 and Rituximab (EU)
    Comparison groups
    ABP 798 v Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.11
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.171
         upper limit
    0.392

    Secondary: Change from Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48

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    End point title
    Change from Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48
    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 included participants in the full analysis set with observed data.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 8, 12, 40, and 48
    End point values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Number of subjects analysed
    104
    104
    103
    Units: units on a scale
    least squares mean (standard error)
        Week 8 (n = 98, 94, 96)
    -1.674 ± 0.1259
    -1.738 ± 0.1335
    -1.527 ± 0.1330
        Week 12 (n = 95, 98, 95)
    -1.746 ± 0.1302
    -2.248 ± 0.1357
    -2.016 ± 0.1367
        Week 40 (n = 93, 93, 92)
    -2.038 ± 0.1440
    -2.293 ± 0.1494
    -2.198 ± 0.1489
        Week 48 (n = 86, 83, 89)
    -2.243 ± 0.1473
    -2.505 ± 0.1553
    -2.323 ± 0.1486
    Statistical analysis title
    Analysis of Change from Baseline at Week 8
    Statistical analysis description
    Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.064
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.203
         upper limit
    0.33
    Statistical analysis title
    Analysis of Change from Baseline at Week 8
    Statistical analysis description
    Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -0.147
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.411
         upper limit
    0.117
    Statistical analysis title
    Analysis of Change from Baseline at Week 12
    Statistical analysis description
    Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.502
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.233
         upper limit
    0.772
    Statistical analysis title
    Analysis of Change from Baseline at Week 12
    Statistical analysis description
    Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.27
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0
         upper limit
    0.539
    Statistical analysis title
    Analysis of Change from Baseline at Week 40
    Statistical analysis description
    Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.255
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.04
         upper limit
    0.55
    Statistical analysis title
    Analysis of Change from Baseline at Week 40
    Statistical analysis description
    Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.16
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.135
         upper limit
    0.455
    Statistical analysis title
    Analysis of Change from Baseline at Week 48
    Statistical analysis description
    Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.262
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.04
         upper limit
    0.564
    Statistical analysis title
    Analysis of Change from Baseline at Week 48
    Statistical analysis description
    Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.08
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.216
         upper limit
    0.376

    Secondary: Percentage of Participants with an ACR20 Response

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    End point title
    Percentage of Participants with an ACR20 Response
    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 included participants in the full analysis set with observed data.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 12, 24, 40, and 48
    End point values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Number of subjects analysed
    104
    104
    103
    Units: percentage of participants
    number (not applicable)
        Week 8 (n = 101, 100, 97)
    56.4
    60.0
    54.6
        Week 12 (n = 102, 101, 98)
    67.6
    73.3
    63.3
        Week 24 (n = 99, 102, 95)
    70.7
    66.7
    64.2
        Week 40 (n = 93, 95, 91)
    68.8
    73.7
    68.1
        Week 48 (n = 87, 84, 88)
    63.2
    79.8
    75.0
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 8
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.9339
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7696
         upper limit
    1.1332
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 8
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.036
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1495
         upper limit
    0.0775
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 8
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0392
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8436
         upper limit
    1.2801
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 8
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0246
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.091
         upper limit
    0.1402
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 12
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.878
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7573
         upper limit
    1.0179
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 12
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0794
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1834
         upper limit
    0.0247
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 12
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0426
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.877
         upper limit
    1.2394
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 12
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0348
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0758
         upper limit
    0.1454
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 24
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0102
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8743
         upper limit
    1.1671
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 24
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0199
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0835
         upper limit
    0.1234
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 24
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0793
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.9244
         upper limit
    1.2601
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 24
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0561
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0493
         upper limit
    0.1615
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 40
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.8848
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7759
         upper limit
    1.0091
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 40
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0776
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1789
         upper limit
    0.0237
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 40
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.9982
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8585
         upper limit
    1.1605
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 40
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0008
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1038
         upper limit
    0.1054
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 48
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.7862
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.6722
         upper limit
    0.9196
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 48
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.2004
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.3066
         upper limit
    -0.0941
    Statistical analysis title
    Risk Ratio Analysis of ACR 20 at Week 48
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.8804
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7587
         upper limit
    1.0215
    Statistical analysis title
    Risk Difference Analysis of ACR 20 at Week 48
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.1037
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.2066
         upper limit
    -0.0007

    Secondary: Percentage of Participants with an ACR50 Response

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    End point title
    Percentage of Participants with an ACR50 Response
    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 included participants in the full analysis set with observed data.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 12, 24, 40, and 48
    End point values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Number of subjects analysed
    104
    104
    103
    Units: percentage of participants
    number (not applicable)
        Week 8 (n = 101, 99, 97)
    26.7
    29.3
    24.7
        Week 12 (n = 102, 101, 98)
    36.3
    47.5
    32.7
        Week 24 (n = 98, 102, 96)
    39.8
    39.2
    38.5
        Week 40 (n = 94, 95, 92)
    48.9
    57.9
    45.7
        Week 48 (n = 86, 84, 88)
    51.2
    58.3
    48.9
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 8
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.9256
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.64
         upper limit
    1.3388
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 8
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0181
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1209
         upper limit
    0.0847
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 8
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0868
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7328
         upper limit
    1.6119
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 8
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0201
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0803
         upper limit
    0.1205
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 12
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.7095
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.5387
         upper limit
    0.9346
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 12
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.1109
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.2231
         upper limit
    0.0013
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 12
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0882
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7829
         upper limit
    1.5127
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 12
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0441
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0626
         upper limit
    0.1508
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 24
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.9612
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7273
         upper limit
    1.2705
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 24
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.002
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1081
         upper limit
    0.1122
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 24
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0029
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.756
         upper limit
    1.3305
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 24
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0039
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1056
         upper limit
    0.1135
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 40
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.8373
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.6797
         upper limit
    1.0316
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 40
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0863
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.2029
         upper limit
    0.0302
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 40
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.1191
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.878
         upper limit
    1.4264
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 40
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0288
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0827
         upper limit
    0.1402
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 48
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.8376
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.6807
         upper limit
    1.0307
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 48
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0781
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.2014
         upper limit
    0.0452
    Statistical analysis title
    Risk Ratio Analysis of ACR 50 at Week 48
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0548
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.8351
         upper limit
    1.3321
    Statistical analysis title
    Risk Difference Analysis of ACR 50 at Week 48
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0141
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1021
         upper limit
    0.1303

    Secondary: Percentage of Participants with an ACR70 Response

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    End point title
    Percentage of Participants with an ACR70 Response
    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 includes participants in the full analysis set with observed data.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 12, 24, 40, and 48
    End point values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Number of subjects analysed
    104
    104
    103
    Units: percentage of participants
    number (not applicable)
        Week 8 (n = 101, 100, 97)
    6.9
    12.0
    9.3
        Week 12 (n = 101, 101, 98)
    12.9
    19.8
    16.3
        Week 24 (n = 99, 102, 96)
    19.2
    19.6
    16.7
        Week 40 (n = 94, 94, 92)
    27.7
    27.7
    22.8
        Week 48 (n = 87, 84, 89)
    28.7
    39.3
    24.7
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 8
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.5926
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.2818
         upper limit
    1.2462
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 8
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0574
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1285
         upper limit
    0.0136
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 8
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.7476
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.3383
         upper limit
    1.6519
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 8
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0327
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0962
         upper limit
    0.0308
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 12
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.6346
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.3704
         upper limit
    1.0872
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 12
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0569
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1448
         upper limit
    0.031
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 12
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.7857
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.445
         upper limit
    1.3874
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 12
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0417
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1237
         upper limit
    0.0403
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 24
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.9254
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.5772
         upper limit
    1.4838
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 24
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0156
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.078
         upper limit
    0.1092
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 24
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.112
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.6722
         upper limit
    1.8398
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 24
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0244
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.063
         upper limit
    0.1119
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 40
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.9798
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.6675
         upper limit
    1.4384
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 40
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0375
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0707
         upper limit
    0.1456
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 40
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.1831
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7833
         upper limit
    1.787
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 40
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0752
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0297
         upper limit
    0.1802
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 48
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.7027
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.493
         upper limit
    1.0017
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 48
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0908
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.211
         upper limit
    0.0294
    Statistical analysis title
    Risk Ratio Analysis of ACR70 at Week 48
    Statistical analysis description
    Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.1449
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7601
         upper limit
    1.7246
    Statistical analysis title
    Risk Difference Analysis of ACR70 at Week 48
    Statistical analysis description
    Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0277
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.0804
         upper limit
    0.1357

    Secondary: Hybrid ACR

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    End point title
    Hybrid ACR
    End point description
    The hybrid ACR combines the ACR 20/50/70 response with the mean percent change in all 7 ACR core components, thus providing a percent improvement from baseline on a continuous scale. For each participant, the mean percent improvement from baseline across the 7 ACR core set measures (tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, disability index of the HAQ, and CRP) was calculated (a positive change indicates improvement, and the maximum worst change is limited to -100%) and the ACR20, ACR50, and ACR70 response is determined. The hybrid ACR is determined from a reference table taking into account both ACR response and mean percent improvement in the core set measures. Scores can range from -100% (maximal worsening) to 100% (maximal improvement). The analysis includes participants in the full analysis set with observed data.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 8, 12, 24, 40, and 48
    End point values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Number of subjects analysed
    104
    104
    103
    Units: percent improvement
    least squares mean (standard error)
        Week 8 (n = 94, 95, 92)
    32.631 ± 2.7287
    34.630 ± 2.8058
    32.086 ± 2.8628
        Week 12 (n = 98, 101, 94)
    36.604 ± 2.8910
    44.828 ± 2.9412
    38.664 ± 3.0360
        Week 24 (n = 94, 100, 93)
    39.269 ± 3.1660
    40.589 ± 3.1781
    38.539 ± 3.2436
        Week 40 (n = 91, 94, 89)
    41.042 ± 3.1508
    43.250 ± 3.1916
    41.078 ± 3.2459
        Week 48 (n = 85, 84, 87)
    41.917 ± 3.3878
    48.546 ± 3.4870
    45.013 ± 3.3942
    Statistical analysis title
    Analysis of Hybrid ACR at Week 8
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -1.999
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.673
         upper limit
    3.675
    Statistical analysis title
    Analysis of Hybrid ACR at Week 8
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.544
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.185
         upper limit
    6.274
    Statistical analysis title
    Analysis of Hybrid ACR at Week 12
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -8.224
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -14.102
         upper limit
    -2.346
    Statistical analysis title
    Analysis of Hybrid ACR at Week 12
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -2.06
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.052
         upper limit
    3.933
    Statistical analysis title
    Analysis of Hybrid ACR at Week 24
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -1.32
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.62
         upper limit
    4.979
    Statistical analysis title
    Analysis of Hybrid ACR at Week 24
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    0.73
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.691
         upper limit
    7.15
    Statistical analysis title
    Analysis of Hybrid ACR at Week 40
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -2.207
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.562
         upper limit
    1.417
    Statistical analysis title
    Analysis of Hybrid ACR at Week 40
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -0.036
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.497
         upper limit
    6.424
    Statistical analysis title
    Analysis of Hybrid ACR at Week 48
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (EU) / Rituximab (EU)
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -6.629
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -13.455
         upper limit
    0.197
    Statistical analysis title
    Analysis of Hybrid ACR at Week 48
    Statistical analysis description
    Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
    Comparison groups
    ABP 798 / ABP 798 v Rituximab (US) / ABP 798
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -3.096
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.883
         upper limit
    3.691

    Secondary: Percentage of Participants with Complete Depletion in CD19+ Cell Count on Day 3

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    End point title
    Percentage of Participants with Complete Depletion in CD19+ Cell Count on Day 3
    End point description
    Complete depletion of cluster of differentiation (CD) 19 positive cells was defined as a CD19+ cell count < 20 cell/μL (0.02 x 10⁹ cell/L). The analysis includes participants in the full analysis set with a day 3 CD19+ cell count; participants with missing CD19+ cell counts at baseline or with CD19+ cell count < 20 cell/μL at baseline were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    97
    96
    97
    Units: percentage of participants
        number (not applicable)
    94.8
    96.9
    92.8
    Statistical analysis title
    Risk Difference Analysis of CD19+ Cell Depletion
    Statistical analysis description
    Risk difference was based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.
    Comparison groups
    ABP 798 v Rituximab (EU)
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.0245
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.1083
         upper limit
    0.0593
    Statistical analysis title
    Risk Difference Analysis of CD19+ Cell Depletion
    Statistical analysis description
    Risk difference was based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.
    Comparison groups
    ABP 798 v Rituximab (US)
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0187
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.061
         upper limit
    0.0984

    Secondary: Duration of Complete Depletion in CD19+ Cell Count

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    End point title
    Duration of Complete Depletion in CD19+ Cell Count
    End point description
    Duration of CD19+ B-cell complete depletion was defined as the time from the first incidence of complete depletion of CD19+ cell count (CD19+ cell count < 20 cells/μL) to when the CD19+ cell count first increased to ≥ 20 cells/μL. Participants whose CD19+ cell count did not increase to ≥ 20 cells/μL were censored at the last CD19+ assessment date. The analysis includes participants in the full analysis set who had a CD19+ complete depletion for at least one postdose time point. "99999" indicates data could not be estimated due to the low number of events.
    End point type
    Secondary
    End point timeframe
    CD19+ cell count was assessed at baseline, days 2, 3, weeks 4, 24, and 48
    End point values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Number of subjects analysed
    95
    99
    98
    Units: days
        median (confidence interval 90%)
    99999 (99999 to 99999)
    99999 (377.0 to 99999)
    99999 (338.0 to 99999)
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs) After the First Dose

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    End point title
    Number of Participants with Adverse Events (AEs) After the First Dose
    End point description
    Adverse events were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. A serious AE was defined as an AE that met at least 1 of the following serious criteria: - fatal - life-threatening - required inpatient hospitalization or prolongation of existing hospitalization - resulted in persistent or significant disability/incapacity - congenital anomaly/birth defect - other medically important serious event. The adverse events of interest prespecified for this study included infusion reactions including hypersensitivity, cardiac disorders, serious infections, progressive multifocal leukoencephalopathy, hematological reactions, hepatitis B reactivation, opportunistic infections, hypogammaglobulinemia, severe mucocutaneous reactions, and gastrointestinal perforation.
    End point type
    Secondary
    End point timeframe
    From day 1 until the first infusion of the second dose (week 24)
    End point values
    ABP 798 Rituximab (EU) Rituximab (US)
    Number of subjects analysed
    104
    104
    103
    Units: participants
        Any adverse event
    52
    44
    44
        Any grade ≥ 3 adverse event
    4
    6
    4
        Any fatal adverse event
    0
    0
    0
        Any serious adverse event
    4
    5
    5
        Any AE leading to discontinuation of drug/study
    3
    1
    4
        Any AE leading to infusion delayed/ not given
    6
    6
    7
        Any adverse event of interest
    19
    11
    18
    No statistical analyses for this end point

    Secondary: Number of Participants who Developed Anti-drug Antibodies

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    End point title
    Number of Participants who Developed Anti-drug Antibodies
    End point description
    Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect antibodies capable of binding to ABP 798/rituximab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against ABP 798/rituximab (Neutralizing Antibody Assay). Developing antibody incidence was defined as participants with a negative or no binding antibody result at baseline and a positive antibody result at any post-baseline time point. The analysis includes participants with a binding negative or no result at baseline and an available postbaseline result.
    End point type
    Secondary
    End point timeframe
    Day 1 through the end of study (48 weeks).
    End point values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Number of subjects analysed
    97
    94
    97
    Units: participants
        Binding antibody positive
    14
    13
    20
        Neutralizing antibody positive
    8
    4
    10
    No statistical analyses for this end point

    Secondary: Number of Participants with Clinically Significant Laboratory Findings

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    End point title
    Number of Participants with Clinically Significant Laboratory Findings
    End point description
    Clinically significant clinical laboratory findings were defined as laboratory results that were ≥ Grade 3, based on the CTCAE version 4.03. The analysis includes All randomized participants who received at least 1 infusion of study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 through the end of study (48 weeks).
    End point values
    ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
    Number of subjects analysed
    104
    104
    103
    Units: participants
        Hemoglobin - decrease (anemia)
    0
    0
    1
        Lymphocytes - decrease
    64
    54
    52
        Alanine aminotransferase - increase
    1
    0
    0
        Gamma glutamyl transferase - increase
    5
    0
    2
        Potassium - increase (hyperkalemia)
    0
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Weeks 1-24: ABP 798
    Reporting group description
    Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).

    Reporting group title
    Weeks 1-24: Rituximab (EU)
    Reporting group description
    Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).

    Reporting group title
    Weeks 1-24: Rituximab (US)
    Reporting group description
    Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).

    Reporting group title
    Weeks 1-48: ABP 798 / ABP 798
    Reporting group description
    Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Reporting group title
    Weeks 1-48: Rituximab (EU) / Rituximab (EU)
    Reporting group description
    Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Reporting group title
    Weeks 1-48: Rituximab (US) / ABP 798
    Reporting group description
    Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

    Serious adverse events
    Weeks 1-24: ABP 798 Weeks 1-24: Rituximab (EU) Weeks 1-24: Rituximab (US) Weeks 1-48: ABP 798 / ABP 798 Weeks 1-48: Rituximab (EU) / Rituximab (EU) Weeks 1-48: Rituximab (US) / ABP 798
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 104 (3.85%)
    5 / 104 (4.81%)
    5 / 103 (4.85%)
    8 / 104 (7.69%)
    8 / 104 (7.69%)
    8 / 103 (7.77%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intraductal papilloma of breast
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    2 / 104 (1.92%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Biliary tract infection
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erythema migrans
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    2 / 104 (1.92%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis syndrome
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    1 / 104 (0.96%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Weeks 1-24: ABP 798 Weeks 1-24: Rituximab (EU) Weeks 1-24: Rituximab (US) Weeks 1-48: ABP 798 / ABP 798 Weeks 1-48: Rituximab (EU) / Rituximab (EU) Weeks 1-48: Rituximab (US) / ABP 798
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 104 (20.19%)
    15 / 104 (14.42%)
    14 / 103 (13.59%)
    38 / 104 (36.54%)
    22 / 104 (21.15%)
    19 / 103 (18.45%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 104 (3.85%)
    2 / 104 (1.92%)
    1 / 103 (0.97%)
    8 / 104 (7.69%)
    3 / 104 (2.88%)
    1 / 103 (0.97%)
         occurrences all number
    5
    2
    1
    11
    3
    1
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    6 / 104 (5.77%)
    2 / 104 (1.92%)
    3 / 103 (2.91%)
    10 / 104 (9.62%)
    3 / 104 (2.88%)
    4 / 103 (3.88%)
         occurrences all number
    6
    2
    4
    13
    3
    7
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 104 (2.88%)
    2 / 104 (1.92%)
    1 / 103 (0.97%)
    7 / 104 (6.73%)
    3 / 104 (2.88%)
    2 / 103 (1.94%)
         occurrences all number
    3
    2
    1
    7
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    5 / 104 (4.81%)
    4 / 104 (3.85%)
    1 / 103 (0.97%)
    9 / 104 (8.65%)
    6 / 104 (5.77%)
    4 / 103 (3.88%)
         occurrences all number
    7
    4
    1
    12
    9
    4
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 104 (5.77%)
    7 / 104 (6.73%)
    8 / 103 (7.77%)
    13 / 104 (12.50%)
    9 / 104 (8.65%)
    11 / 103 (10.68%)
         occurrences all number
    6
    8
    9
    15
    13
    13

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2016
    • modification of the inclusion criteria as follows: - to specify subjects must have had intolerance or an inadequate response to one or more TNF inhibitor therapies - to specify that subjects must have completed at least 4 weeks of a TB prophylaxis regimen prior to enrollment • modification of the exclusion criteria as follows: - to allow subjects with a positive hepatitis B surface antigen or hepatitis B core antibody result to enroll provided documentation of hepatitis B virus immunization is provided - to add adalimumab to the list of biologic therapies not allowed within 3 months prior to first dose of investigational product - to add ocrelizumab to the list of prohibited prior treatments
    16 Oct 2017
    • revised to include only DAS28-CRP change from baseline at week 24 as the endpoint supporting the secondary objective of efficacy instead of both DAS28-CRP change from baseline at week 24 and ACR20 at week 24; DAS28-CRP at weeks 8, 12, 40, and 48 and ACR20 at weeks 8, 12, 24, 40, and 48 were additional efficacy assessments • revised margin for DAS28-CRP to ± 0.6 • corrected multiplicity adjustments and error rates for statistical analysis of PK variables
    20 Mar 2018
    • removed reference to conducting primary analysis and replaced with reference to conducting final analysis • added a secondary objective to demonstrate PK similarity of rituximab (US) and rituximab (EU) • updated sample size estimation and statistical methods language to clarify efficacy analysis • specified the statistical approach for efficacy evaluation to include pooling of rituximab data if PK similarity between rituximab (US) and rituximab (EU) is established

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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