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    Clinical Trial Results:
    An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2013-004654-13
    Trial protocol
    		 CZ   HU   GB   ES   DE   BG   PL   RO  
    Global end of trial date
    11 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2017
    First version publication date
    01 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20130258
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02114931
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Agen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis (RA).
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines, the general guidelines indicated in the Declaration of Helsinki, and all applicable regulatory requirements. All subjects provided written informed consent before undergoing any study-related procedures, including screening procedures. The study protocol, amendments, and the informed consent form (ICF) were reviewed by the Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). No subjects were recruited into the study and no investigational product (IP) was shipped until the IRB/IEC gave written approval of the protocol and ICF and Amgen received copies of these approvals.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Apr 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 181
    Country: Number of subjects enrolled
    Czech Republic: 55
    Country: Number of subjects enrolled
    Hungary: 52
    Country: Number of subjects enrolled
    Bulgaria: 17
    Country: Number of subjects enrolled
    Romania: 3
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    United States: 121
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    467
    EEA total number of subjects
    339
    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)
    364
    From 65 to 84 years
    103
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 83 centers in 11 countries in Eastern Europe, North America and Western Europe.

    Pre-assignment
    Screening details
    		 Study 20130258 was a single-arm, open-label extension of the parent Study 20120262 (2013-000525-31). Results are reported according to treatment in the parent Study 20120262.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABP 501/ABP 501
    Arm description
    		 Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABP-501
    Investigational medicinal product code
    ABP 501
    Other name
    AMJEVITA™, Adalimumab-atto
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Solution for SC injection in a syringe containing 40 mg/0.8 mL ABP 501.

    Arm title
    		 Adalimumab/ABP 501
    Arm description
    		 Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABP-501
    Investigational medicinal product code
    ABP 501
    Other name
    AMJEVITA™, Adalimumab-atto
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Solution for SC injection in a syringe containing 40 mg/0.8 mL ABP 501.

    Number of subjects in period 1
    		ABP 501/ABP 501 Adalimumab/ABP 501
    Started
    230
    237
    Received Treatment
    229
    237
    Completed
    205
    207
    Not completed
    25
    30
         Consent withdrawn by subject
    15
    18
         Physician decision
    1
    2
         Adverse event, non-fatal
    4
    6
         Other
    2
    1
         Lost to follow-up
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABP 501/ABP 501
    Reporting group description
    		 Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).

    Reporting group title
    Adalimumab/ABP 501
    Reporting group description
    		 Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.

    Reporting group values
    		 ABP 501/ABP 501 Adalimumab/ABP 501 Total
    Number of subjects
    		 230 237 467
    Age Categorical
    Age at baseline of parent study
    Units: Subjects
        Between 18 and 65 years
    		 183 181 364
        ≥ 65 years
    		 47 56 103
    Age Continuous
    Age at baseline of parent study
    Units: years
        arithmetic mean (standard deviation)
    		 54.7 ( 11.71 ) 56.1 ( 11.4 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 188 191 379
        Male
    		 42 46 88
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 218 224 442
        Black or African American
    		 8 12 20
        Asian
    		 3 0 3
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Mixed Race
    		 0 0 0
        Other
    		 1 1 2
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 27 19 46
        Not Hispanic or Latino
    		 202 217 419
        Not Allowed to Collect
    		 1 1 2
    Geographic Region
    Units: Subjects
        Eastern Europe
    		 153 156 309
        Western Europe
    		 12 19 31
        North America
    		 65 62 127
        Latin America
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    ABP 501/ABP 501
    Reporting group description
    		 Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).

    Reporting group title
    Adalimumab/ABP 501
    Reporting group description
    		 Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.

    Primary: Number of Participants with Adverse Events

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    End point title
    		 Number of Participants with Adverse Events [1]
    End point description
    Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question “is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product” was yes. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening (places the subject at immediate risk of death) • requires inpatient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
    End point type
    Primary
    End point timeframe
    From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential analyses were performed.
    End point values
    		 ABP 501/ABP 501 Adalimumab/ABP 501
    Number of subjects analysed
    229
    237
    Units: participants
        Any adverse event (AE)
    143
    154
        Any grade ≥ 3 adverse event
    26
    16
        Any treatment-related adverse event (TRAE)
    37
    43
        Any grade ≥ 3 treatment-related adverse event
    3
    4
        Any adverse event with outcome of death
    0
    0
        Any TRAE with an outcome of death
    0
    0
        Any serious adverse event (SAE)
    25
    21
        Any treatment-related serious adverse event
    2
    1
        Any AE leading to discontinuation of ABP 501
    7
    10
        Any TRAE leading to discontinuation of ABP 501
    4
    5
        Any AE leading to discontinuation from study
    3
    5
        Any TRAE leading to discontinuation from study
    1
    3
    No statistical analyses for this end point

    Primary: Number of Participants with Grade ≥ 3 Hematology and Chemistry Laboratory Results

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    End point title
    		 Number of Participants with Grade ≥ 3 Hematology and Chemistry Laboratory Results [2]
    End point description
    Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal.
    End point type
    Primary
    End point timeframe
    From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential analyses were performed.
    End point values
    		 ABP 501/ABP 501 Adalimumab/ABP 501
    Number of subjects analysed
    229
    237
    Units: participants
        Hemoglobin (anemia)
    1
    0
        Alanine aminotransferase (ALT)
    1
    0
        Aspartate aminotransferase (AST)
    1
    0
        Bilirubin
    1
    0
        Gamma glutamyl transferase
    7
    3
        Potassium (hyperkalemia)
    1
    1
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Developed Antibodies to ABP 501

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    End point title
    		 Percentage of Participants Who Developed Antibodies to ABP 501 [3]
    End point description
    Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies. Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study.
    End point type
    Primary
    End point timeframe
    Up to week 72
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential analyses were performed.
    End point values
    		 ABP 501/ABP 501 Adalimumab/ABP 501
    Number of subjects analysed
    229
    237
    Units: percentage of participants
    number (not applicable)
        Preexisting Binding Antibody Positive
    32.3
    34.2
        Preexisting Neutralizing Antibody Positive
    5.7
    8.9
        Developing Binding Antibody Positive
    21.8
    14.8
        Developing Neutralizing Antibody Positive
    8.7
    5.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response

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    End point title
    		 Percentage of Participants With an American College of Rheumatology (ACR) 20 Response
    End point description
    A participant was a responder if the following 3 criteria for improvement from Baseline of the parent study were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-Reactive Protein level.
    End point type
    Secondary
    End point timeframe
    Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70
    End point values
    		 ABP 501/ABP 501 Adalimumab/ABP 501
    Number of subjects analysed
    230
    237
    Units: percentage of participants
    number (not applicable)
        Extension study baseline (n = 228, 236)
    73.2
    73.3
        Week 4 (n = 228, 237)
    77.6
    77.6
        Week 24 (n = 223, 230)
    74
    74.3
        Week 48 (n = 216, 218)
    76.9
    78.4
        Week 70 (n = 206, 209)
    79.6
    78
    No statistical analyses for this end point

    Secondary: Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)

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    End point title
    		 Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)
    End point description
    The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level; • Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable). The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity.
    End point type
    Secondary
    End point timeframe
    Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70
    End point values
    		 ABP 501/ABP 501 Adalimumab/ABP 501
    Number of subjects analysed
    230
    237
    Units: units on a scale
    arithmetic mean (standard deviation)
        Extension Study Baseline (n = 219, 221)
    -2.26 ( 1.255 )
    -2.25 ( 1.289 )
        Week 4 (n = 228, 235)
    -2.4 ( 1.322 )
    -2.32 ( 1.257 )
        Week 24 (n = 223, 227)
    -2.49 ( 1.272 )
    -2.33 ( 1.316 )
        Week 48 (n = 216, 217)
    -2.59 ( 1.433 )
    -2.51 ( 1.414 )
        Week 70 (n = 205, 207)
    -2.7 ( 1.389 )
    -2.51 ( 1.445 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ABP 501/ABP 501
    Reporting group description
    		 Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).

    Reporting group title
    Adalimumab/ABP 501
    Reporting group description
    		 Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.

    Serious adverse events
    		 ABP 501/ABP 501 Adalimumab/ABP 501
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 229 (10.92%)
    21 / 237 (8.86%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Bunion operation
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthesis implantation
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device failure
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine cervical erosion
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Aortic valve stenosis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 229 (0.87%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 229 (0.44%)
    2 / 237 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    2 / 229 (0.87%)
    3 / 237 (1.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 229 (0.87%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 237 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salpingitis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 237 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABP 501/ABP 501 Adalimumab/ABP 501
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 229 (31.44%)
    71 / 237 (29.96%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    16 / 229 (6.99%)
    6 / 237 (2.53%)
         occurrences all number
    16
    6
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    11 / 229 (4.80%)
    17 / 237 (7.17%)
         occurrences all number
    15
    21
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    16 / 229 (6.99%)
    13 / 237 (5.49%)
         occurrences all number
    16
    14
    Nasopharyngitis
         subjects affected / exposed
    18 / 229 (7.86%)
    25 / 237 (10.55%)
         occurrences all number
    26
    34
    Pharyngitis
         subjects affected / exposed
    12 / 229 (5.24%)
    7 / 237 (2.95%)
         occurrences all number
    14
    10
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 229 (7.86%)
    22 / 237 (9.28%)
         occurrences all number
    21
    29

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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