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    Clinical Trial Results:
    A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar etanercept (GP2015) and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis

    Summary
    EudraCT number
    		 2012-002011-26
    Trial protocol
    		 SK   HU   CZ   GB   EE   DE   BG   PL  
    Global end of trial date
    30 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2016
    First version publication date
    31 Mar 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GP15-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01891864
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sandoz
    Sponsor organisation address
    Industriestrasse 25, Holzkirchen, Germany, 83607
    Public contact
    Strategic Planning Biopharma Clinical Development, Sandoz, 0049 8024 / 476 - 0, biopharma.clinicaltrials@sandoz.com
    Scientific contact
    Strategic Planning Biopharma Clinical Development, Sandoz, 0049 8024 / 476 - 0, biopharma.clinicaltrials@sandoz.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
    19 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study was to demonstrate equivalence in efficacy (primarily based on PASI 75 response rate) and similarity in the safety profile of GP2015 and Enbrel® (EU-licensed) in patients with moderate to severe chronic plaque-type psoriasis and to evaluate the effects of repeated switching between GP2015 and Enbrel® on efficacy, overall safety and immunogenicity.
    Protection of trial subjects
    This trial was designed, conducted and reported in accordance with the international Conference on Harmonization (!CH) Guidelines for Good Clinical Practice (GCP), applicable local regulations (including European Directive 2001/20/EC), and following the ethical principles laid down in the Declaration of Helsinki. Specific ICH adopted and other relevant international guidelines and recommendations were taken into account as far as meaningfully possible, as long as they did not conflict with applicable UK law. Safety assessments included adverse events (AEs), vital signs, 12-lead ECG parameters, clinical laboratory, immunogenicity, physical examination and other parameters considered relevant for the safety assessment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jun 2013
    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: 190
    Country: Number of subjects enrolled
    Romania: 33
    Country: Number of subjects enrolled
    Bulgaria: 21
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    Estonia: 81
    Country: Number of subjects enrolled
    Russian Federation: 17
    Country: Number of subjects enrolled
    Ukraine: 42
    Country: Number of subjects enrolled
    Czech Republic: 41
    Country: Number of subjects enrolled
    South Africa: 5
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Slovakia: 37
    Worldwide total number of subjects
    531
    EEA total number of subjects
    467
    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)
    503
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was a multicenter, randomized, double-blind, confirmatory safety and efficacy study. In total 774 patients were screened to randomize 531 patients with moderate to severe chronic plaque-type psoriasis. Patients were randomized at 71study centers in 12 countries.

    Pre-assignment
    Screening details
    		 Prior to baseline (Treatment Day 1, Visit 2) patients were to undergo an eligibility assessment period of at least 2 weeks and up to a maximum of 4 weeks duration.

    Period 1
    Period 1 title
    Treatment period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    All treatment assignments were blinded and concealed from patients and investigator site staff. A patient randomization list will be produced by the IRT provider using a validated system. Each patient randomization number is associated with one of the treatment arms.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GP2015
    Arm description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week12
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    GP2015
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week12 The total number of IMP injections is 24 during Treatment Period 1 (two per week from Treatment Day 1 to Week 12)

    Arm title
    		 Enbrel
    Arm description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug until Week12
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Enbrel
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enbrel 50 mg subcutaneous (s.c.) injection of study drug until Week12 The total number of IMP injections is 24 during Treatment Period 1 (two per week from Treatment Day 1 to Week 12).

    Number of subjects in period 1
    		GP2015 Enbrel
    Started
    264
    267
    Completed
    256
    255
    Not completed
    8
    12
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    2
    5
         Physician decision
    -
    1
         Adverse event, non-fatal
    4
    4
         Lost to follow-up
    1
    -
         Protocol deviation
    1
    1
    Period 2
    Period 2 title
    Treatment period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    All treatment assignments were blinded and concealed from patients and investigator site staff. A patient randomization list will be produced by the IRT provider using a validated system. Each patient randomization number is associated with one of the treatment arms.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GP2015 continued
    Arm description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 in patients who had achieved at least a PASI50 response at Week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    GP2015
    Investigational medicinal product code
    GP2015
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30. The total number of IMP injections is 18 during Treatment Period 2 (one per week from Week 13 to Week 30)

    Arm title
    		 Enbrel continued
    Arm description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 in patients who had achieved at least a PASI50 response at Week 12
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Enbrel
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30. The total number of IMP injections is 18 during Treatment Period 2 (one per week from Week 13 to Week 30).

    Arm title
    		 GP2015 switched
    Arm description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 in patients who had achieved at least a PASI50 response at Week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    GP2015 in period 1/Enbrel/GP 2015/Enbrel
    Investigational medicinal product code
    GP2015/Enbrel
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GP2015/Enbrel 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel. The total number of IMP injections is 18 during Treatment Period 2 (one per week from Treatment Week 13 to Week 30)

    Arm title
    		 Enbrel switched
    Arm description
    		 Enbrel/GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 in patients who had achieved at least a PASI50 response at Week 30
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Enbrel in period 1/GP2015/Enbrel/GP2015
    Investigational medicinal product code
    Enbrel/GP2015
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enbrel/GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015. The total number of IMP injections is 18 during Treatment Period 2 (one per week from Treatment Week 13 to Week 30)

    Number of subjects in period 2 [1]
    		GP2015 continued Enbrel continued GP2015 switched Enbrel switched
    Started
    150
    151
    100
    96
    Completed
    143
    142
    96
    91
    Not completed
    7
    9
    4
    5
         Consent withdrawn by subject
    3
    4
    1
    1
         Physician decision
    1
    -
    -
    -
         Adverse event, non-fatal
    1
    2
    -
    4
         site termination
    1
    2
    -
    -
         termination of site
    -
    -
    2
    -
         Lack of efficacy
    1
    -
    1
    -
         Protocol deviation
    -
    1
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only patients with a PASI50 response at 12 weeks -continuing treatment- were included in treatment period 2.
    Period 3
    Period 3 title
    Extension period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    All treatment assignments were blinded and concealed from patients and investigator site staff. A patient randomization list will be produced by the IRT provider using a validated system. Each patient randomization number is associated with one of the treatment arms.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GP2015 continued
    Arm description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GP2015
    Investigational medicinal product code
    GP2015
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2. The total number of IMP injections is 22 during the Extension Period.

    Arm title
    		 Enbrel continued
    Arm description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Enbrel
    Investigational medicinal product code
    Enbrel
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2. The total number of IMP injections is 22 during the Extension Period

    Arm title
    		 GP2015 switched
    Arm description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Enbrel
    Investigational medicinal product code
    Enbrel
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2. The total number of IMP injections is 22 during the Extension Period. They continued the drug last used in treatment period 2.

    Arm title
    		 Enbrel switched
    Arm description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GP2015
    Investigational medicinal product code
    GP2015
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2. The total number of IMP injections is 22 during the Extension Period. The last drug used in treatment period 2 was continued in the extension period.

    Number of subjects in period 3 [2]
    		GP2015 continued Enbrel continued GP2015 switched Enbrel switched
    Started
    140
    142
    95
    90
    Completed
    132
    137
    88
    90
    Not completed
    8
    5
    7
    0
         Consent withdrawn by subject
    1
    2
    4
    -
         Adverse event, non-fatal
    4
    2
    2
    -
         Pregnancy
    1
    -
    -
    -
         Lost to follow-up
    2
    -
    -
    -
         Lack of efficacy
    -
    1
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only patients completing treatment period 2 and continuing in the extension period participated

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GP2015
    Reporting group description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week12

    Reporting group title
    Enbrel
    Reporting group description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug until Week12

    Reporting group values
    		 GP2015 Enbrel Total
    Number of subjects
    		 264 267 531
    Age categorical
    Units: Subjects
        Age 18-64
    		 254 249 503
        Age 65-85
    		 10 18 28
    Age continuous
    Age treatment period 1
    Units: years
        arithmetic mean (standard deviation)
    		 42.1 ± 12.29 42.7 ± 12.86 -
    Gender categorical
    Male and female numbers
    Units: Subjects
        Female
    		 107 95 202
        Male
    		 157 172 329
    Weight
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 86.3 ± 21.12 85.9 ± 18.72 -
    BMI
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 28.561 ± 6.0953 28.0458 ± 5.4632 -

    End points

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    End points reporting groups
    Reporting group title
    GP2015
    Reporting group description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week12

    Reporting group title
    Enbrel
    Reporting group description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug until Week12
    Reporting group title
    GP2015 continued
    Reporting group description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 in patients who had achieved at least a PASI50 response at Week 12

    Reporting group title
    Enbrel continued
    Reporting group description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 in patients who had achieved at least a PASI50 response at Week 12

    Reporting group title
    GP2015 switched
    Reporting group description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 in patients who had achieved at least a PASI50 response at Week 12

    Reporting group title
    Enbrel switched
    Reporting group description
    		 Enbrel/GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 in patients who had achieved at least a PASI50 response at Week 30
    Reporting group title
    GP2015 continued
    Reporting group description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2.

    Reporting group title
    Enbrel continued
    Reporting group description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2.

    Reporting group title
    GP2015 switched
    Reporting group description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2.

    Reporting group title
    Enbrel switched
    Reporting group description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 in patients who had completed treatment period 2.

    Primary: PASI 75 response rate at Week 12 between GP2015 and Enbrel

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    End point title
    		 PASI 75 response rate at Week 12 between GP2015 and Enbrel
    End point description
    The 95% CI for the PASI 75 response rate differences at Week12 between GP2015 and Enbrel.
    End point type
    Primary
    End point timeframe
    The PASI 75 response reate was determined at 12 weeks.
    End point values
    		 GP2015 Enbrel
    Number of subjects analysed
    239 [1]
    241 [2]
    Units: percentage
        number (not applicable)
    73.4
    75.7
    Notes
    [1] - PPS
    [2] - PPS
    Statistical analysis title
    		 95% CI of PASI 75 response difference at week12
    Statistical analysis description
    PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1) was the primary endpoint to assess equivalence between GP2015 and Enbrel®. Therapeutic equivalence in terms of PASI75 could be concluded if the exact 95% confidence interval for the difference in the PASI75 rates is completely contained within the interval [−18%; 18%]. A logistic regression model was to be employed.
    Comparison groups
    GP2015 v Enbrel
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    P-value
    		 < 0.025
    Method
    		 Regression, Logistic
    Parameter type
    		 95% CI of response rate differences
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.85
         upper limit
    		 5.3
    Notes
    [3] - The analysis of the primary variable was based on the PPS.

    Secondary: % change from baseline in PASI score up to Week12

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    End point title
    		 % change from baseline in PASI score up to Week12
    End point description
    The key sec. efficacy endpoint in TP1 was the % change from baseline in PASI score up to Week12. Two approaches (MMRM and ATE approach) were employed in order to calculate 2-sided 95% CIs for the difference between the treatment groups.
    End point type
    Secondary
    End point timeframe
    Percent change in PASI between baseline to week 12.
    End point values
    		 GP2015 Enbrel
    Number of subjects analysed
    239
    241
    Units: percentage difference
        number (not applicable)
    -56.11
    -55.48
    Statistical analysis title
    		 MMRM method percentage change PASI response 0-12 w
    Statistical analysis description
    A MMRM (Mixed Model Repeated Method) was performed on the percentage change from baseline in PASI score from baseline to Week 12. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval [−15%; 15%].
    Comparison groups
    GP2015 v Enbrel
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.025
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.474
         upper limit
    		 2.204
    Statistical analysis title
    		 ATE of PASI response from baseline to week 12
    Statistical analysis description
    The mean averaged treatment effect (ATE) of percent change from baseline in PASI score up to week 12 was derived for each patient and analyzed using an ANCOVA apporach. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval [−15%; 15%].
    Comparison groups
    GP2015 v Enbrel
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.025
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.61
         upper limit
    		 1.845

    Secondary: % Change from baseline in PASI score at the end of treatment period 2

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    End point title
    		 % Change from baseline in PASI score at the end of treatment period 2
    End point description
    Percentage change in PASI score at the end of treatment period 2 at 30 weeks.
    End point type
    Secondary
    End point timeframe
    Between week 0 and week 30
    End point values
    		 GP2015 continued Enbrel continued GP2015 switched Enbrel switched
    Number of subjects analysed
    137 [4]
    129 [5]
    90 [6]
    88 [7]
    Units: percentage
        arithmetic mean (standard deviation)
    -88.955 ± 12.3509
    -88.885 ± 12.3666
    -88.287 ± 13.5151
    -88.517 ± 13.9095
    Notes
    [4] - PPS
    [5] - PPS
    [6] - PPS
    [7] - PPS
    No statistical analyses for this end point

    Secondary: % Change from baseline in PASI score at the end of the extension period

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    End point title
    		 % Change from baseline in PASI score at the end of the extension period
    End point description
    Percentage change in PASI score between baseline and end of the extension period.
    End point type
    Secondary
    End point timeframe
    Between baseline and 52 weeks
    End point values
    		 GP2015 continued Enbrel continued GP2015 switched Enbrel switched
    Number of subjects analysed
    126 [8]
    128 [9]
    85 [10]
    87 [11]
    Units: percentage
        arithmetic mean (standard deviation)
    -87.833 ± 16.8661
    -86.597 ± 15.9226
    -85.574 ± 19.4098
    -88.527 ± 15.752
    Notes
    [8] - PPS
    [9] - PPS
    [10] - PPS
    [11] - PPS
    No statistical analyses for this end point

    Other pre-specified: PASI 75 response rate at the end of treatment period 2

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    End point title
    		 PASI 75 response rate at the end of treatment period 2
    End point description
    PASI 75 response rate at 30 weeks.
    End point type
    Other pre-specified
    End point timeframe
    At week 30
    End point values
    		 GP2015 continued Enbrel continued GP2015 switched Enbrel switched
    Number of subjects analysed
    119
    112
    78
    76
    Units: percentage
        number (not applicable)
    86.9
    86.8
    86.7
    86.4
    No statistical analyses for this end point

    Other pre-specified: PASI 75 response rate at the end of the extension period

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    End point title
    		 PASI 75 response rate at the end of the extension period
    End point description
    PASI 75 response rate at 52 weeks.
    End point type
    Other pre-specified
    End point timeframe
    At week 52
    End point values
    		 GP2015 continued Enbrel continued GP2015 switched Enbrel switched
    Number of subjects analysed
    108
    104
    71
    74
    Units: percentage
        number (not applicable)
    85.7
    81.3
    83.5
    85.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    To ensure patient safety, every SAE/AE, regardless of suspected causality, occurring after the patient has provided informed consent and until 30 days after the patient has stopped study participation
    Adverse event reporting additional description
    The occurrence of AEs should be sought by non-directive questioning of the patient at each visit during the study. AEs also may be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    GP2015 continued
    Reporting group description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week52

    Reporting group title
    Enbrel switched
    Reporting group description
    		 GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week52

    Reporting group title
    GP2015 switched
    Reporting group description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug until Week52

    Reporting group title
    Enbrel continued
    Reporting group description
    		 Enbrel 50 mg subcutaneous (s.c.) injection of study drug until Week52

    Serious adverse events
    		 GP2015 continued Enbrel switched GP2015 switched Enbrel continued
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 164 (6.10%)
    6 / 96 (6.25%)
    11 / 100 (11.00%)
    7 / 171 (4.09%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiopulmonary failure
    Additional description: Fatal event
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Umbilical hernia
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric vascular insufficiency
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    renal failure acute
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain abscess
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lobar pneumonia
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema infected
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acid-base balance disorder mixed
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 GP2015 continued Enbrel switched GP2015 switched Enbrel continued
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    134 / 164 (81.71%)
    89 / 96 (92.71%)
    99 / 100 (99.00%)
    118 / 171 (69.01%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 164 (3.05%)
    2 / 96 (2.08%)
    3 / 100 (3.00%)
    7 / 171 (4.09%)
         occurrences all number
    5
    2
    3
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 164 (0.00%)
    2 / 96 (2.08%)
    2 / 100 (2.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Fatigue
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    3 / 171 (1.75%)
         occurrences all number
    1
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 164 (1.83%)
    0 / 96 (0.00%)
    3 / 100 (3.00%)
    2 / 171 (1.17%)
         occurrences all number
    3
    0
    3
    2
    oropharyngeal pain
         subjects affected / exposed
    3 / 164 (1.83%)
    1 / 96 (1.04%)
    3 / 100 (3.00%)
    2 / 171 (1.17%)
         occurrences all number
    3
    1
    3
    2
    Investigations
    Blood pressure increased
         subjects affected / exposed
    2 / 164 (1.22%)
    0 / 96 (0.00%)
    4 / 100 (4.00%)
    2 / 171 (1.17%)
         occurrences all number
    2
    0
    4
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 164 (3.66%)
    2 / 96 (2.08%)
    1 / 100 (1.00%)
    2 / 171 (1.17%)
         occurrences all number
    6
    2
    1
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 164 (3.05%)
    2 / 96 (2.08%)
    1 / 100 (1.00%)
    1 / 171 (0.58%)
         occurrences all number
    5
    2
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    6 / 164 (3.66%)
    0 / 96 (0.00%)
    3 / 100 (3.00%)
    0 / 171 (0.00%)
         occurrences all number
    6
    0
    3
    0
    Weight increased
         subjects affected / exposed
    2 / 164 (1.22%)
    0 / 96 (0.00%)
    3 / 100 (3.00%)
    4 / 171 (2.34%)
         occurrences all number
    2
    0
    3
    4
    Blood uric acid increased
         subjects affected / exposed
    3 / 164 (1.83%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    2 / 171 (1.17%)
         occurrences all number
    3
    0
    0
    2
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    0 / 164 (0.00%)
    2 / 96 (2.08%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Headache
         subjects affected / exposed
    3 / 164 (1.83%)
    3 / 96 (3.13%)
    4 / 100 (4.00%)
    8 / 171 (4.68%)
         occurrences all number
    3
    3
    4
    8
    Somnolence
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    2 / 100 (2.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Blood and lymphatic system disorders
    Lymph node pain
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    4 / 164 (2.44%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    4
    1
    1
    0
    Eye disorders
    Eye haemorrhage
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 164 (2.44%)
    3 / 96 (3.13%)
    1 / 100 (1.00%)
    2 / 171 (1.17%)
         occurrences all number
    4
    3
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    3 / 164 (1.83%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    3 / 171 (1.75%)
         occurrences all number
    3
    0
    0
    3
    Nausea
         subjects affected / exposed
    0 / 164 (0.00%)
    2 / 96 (2.08%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 164 (0.00%)
    2 / 96 (2.08%)
    2 / 100 (2.00%)
    4 / 171 (2.34%)
         occurrences all number
    0
    2
    2
    4
    Toothache
         subjects affected / exposed
    0 / 164 (0.00%)
    3 / 96 (3.13%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 164 (0.00%)
    2 / 96 (2.08%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hepatitis alcoholic
         subjects affected / exposed
    0 / 164 (0.00%)
    2 / 96 (2.08%)
    0 / 100 (0.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    2 / 100 (2.00%)
    5 / 171 (2.92%)
         occurrences all number
    0
    1
    2
    5
    Pruritus
         subjects affected / exposed
    2 / 164 (1.22%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    4 / 171 (2.34%)
         occurrences all number
    2
    0
    0
    4
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    3 / 164 (1.83%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    3
    0
    0
    1
    Pruritis generalized
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    3 / 164 (1.83%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    1 / 171 (0.58%)
         occurrences all number
    3
    1
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 164 (3.05%)
    5 / 96 (5.21%)
    3 / 100 (3.00%)
    7 / 171 (4.09%)
         occurrences all number
    5
    5
    3
    7
    Back pain
         subjects affected / exposed
    7 / 164 (4.27%)
    4 / 96 (4.17%)
    2 / 100 (2.00%)
    3 / 171 (1.75%)
         occurrences all number
    7
    4
    2
    3
    Spinal pain
         subjects affected / exposed
    2 / 164 (1.22%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    2 / 171 (1.17%)
         occurrences all number
    2
    0
    0
    2
    Pain in extremity
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    2 / 100 (2.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    7 / 164 (4.27%)
    3 / 96 (3.13%)
    5 / 100 (5.00%)
    10 / 171 (5.85%)
         occurrences all number
    7
    3
    5
    10
    Nasopharyngitis
         subjects affected / exposed
    20 / 164 (12.20%)
    10 / 96 (10.42%)
    14 / 100 (14.00%)
    17 / 171 (9.94%)
         occurrences all number
    20
    10
    14
    17
    Viral upper respiratory tract infection
         subjects affected / exposed
    5 / 164 (3.05%)
    8 / 96 (8.33%)
    4 / 100 (4.00%)
    6 / 171 (3.51%)
         occurrences all number
    5
    8
    4
    6
    Respiratory tract infection viral
         subjects affected / exposed
    4 / 164 (2.44%)
    1 / 96 (1.04%)
    4 / 100 (4.00%)
    2 / 171 (1.17%)
         occurrences all number
    4
    1
    4
    2
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 164 (2.44%)
    3 / 96 (3.13%)
    1 / 100 (1.00%)
    5 / 171 (2.92%)
         occurrences all number
    4
    3
    1
    5
    Rhinitis
         subjects affected / exposed
    2 / 164 (1.22%)
    3 / 96 (3.13%)
    1 / 100 (1.00%)
    4 / 171 (2.34%)
         occurrences all number
    2
    3
    1
    4
    Bronchitis
         subjects affected / exposed
    4 / 164 (2.44%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    3 / 171 (1.75%)
         occurrences all number
    4
    0
    0
    3
    Tonsillitis
         subjects affected / exposed
    5 / 164 (3.05%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    1 / 171 (0.58%)
         occurrences all number
    5
    1
    1
    1
    Influenza
         subjects affected / exposed
    2 / 164 (1.22%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    3 / 171 (1.75%)
         occurrences all number
    2
    0
    0
    3
    Oral herpes
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    2 / 100 (2.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 164 (1.22%)
    1 / 96 (1.04%)
    2 / 100 (2.00%)
    3 / 171 (1.75%)
         occurrences all number
    2
    1
    2
    3
    Viral infection
         subjects affected / exposed
    3 / 164 (1.83%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    2 / 171 (1.17%)
         occurrences all number
    3
    1
    1
    2
    Cystitis
         subjects affected / exposed
    3 / 164 (1.83%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    3
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    2 / 100 (2.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Herpes simplex
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    2 / 100 (2.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    2 / 100 (2.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 96 (1.04%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 164 (0.00%)
    2 / 96 (2.08%)
    1 / 100 (1.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 96 (0.00%)
    2 / 100 (2.00%)
    0 / 171 (0.00%)
         occurrences all number
    0
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Sep 2013
    This protocol is amended to implement advice received from national European Health Authorities, including recommendations to apply a 95% rather than a 90% confidence interval to the primary endpoint and to increase the size of the safety database for continuous treatment with GP2015 in comparison to the reference product. The sample size is increased to 546 randomized patients; the number of study sites is increased accordingly. The re-randomization scheme at week 12 is changed to a ratio of 3:1 instead of 1:1: 75% of patients will continue on their assigned treatment arm (either GP2015 or Enbrel®) whilst 25% will be randomized to receive alternating treatment. The confidence interval is increased to 95%.

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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