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    Clinical Trial Results:
    A Randomized, Double-blind, Confirmatory Trial to Evaluate the Efficacy, Safety, and Immunogenicity of MSB11022 Compared with European Union-approved Humira® in Subjects with Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    		 2015-003287-37
    Trial protocol
    		 BG   DE   GB   CZ   HU  
    Global end of trial date
    18 Dec 2017

    Results information
    Results version number
    		 v3(current)
    This version publication date
    22 Jan 2020
    First version publication date
    25 Oct 2018
    Other versions
    		 v1 , v2
    Version creation reason
    • New data added to full data set
    Sponsor representative\scientific responsible changed

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EMR200588-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02660580
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fresenius Kabi SwissBioSim GmbH
    Sponsor organisation address
    Route de Crassier 23 – Bâtiment A3, Eysins, Switzerland, 1262
    Public contact
    Eugenia Kunina, Fresenius Kabi SwissBioSim GmbH, +41 79 1093376, eugenia.kunina@fresenius-kabi.com
    Scientific contact
    Eugenia Kunina, Fresenius Kabi SwissBioSim GmbH, +41 791093376, eugenia.kunina@fresenius-kabi.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
    18 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to demonstrate equivalence in efficacy of MSB11022 compared to EU-approved Humira in subjects with moderate to severe chronic plaque psoriasis.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the ethical principles of the International Council for Harmonisation (ICH) guideline for Good Clinical Practice (GCP) and the Declaration of Helsinki, as well as with applicable local regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Feb 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
    Bulgaria: 34
    Country: Number of subjects enrolled
    Canada: 51
    Country: Number of subjects enrolled
    Czech Republic: 57
    Country: Number of subjects enrolled
    Estonia: 41
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    Mexico: 31
    Country: Number of subjects enrolled
    Poland: 156
    Country: Number of subjects enrolled
    Russian Federation: 24
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    443
    EEA total number of subjects
    331
    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)
    422
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were randomized to receive either MSB11022 or EU-Humira in Core Treatment Period till Week 16. Subjects who achieved PASI 50 at Week 16 entered Extension Period where subjects in MSB11022 arm were continued to receive MSB11022 and subjects in EU-Humira arm were re-randomized to receive either MSB11022 or EU-Humira for additional 37 weeks.

    Period 1
    Period 1 title
    Core Treatment Period (Week 1 to 16)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MSB11022 (Core Treatment Period)
    Arm description
    		 Subjects received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MSB11022
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received MSB11022 subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14.

    Arm title
    		 EU-Humira
    Arm description
    		 Subjects received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EU-Humira
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14.

    Number of subjects in period 1
    		MSB11022 (Core Treatment Period) EU-Humira
    Started
    222
    221
    Treated
    221
    220
    Completed
    213
    202
    Not completed
    9
    19
         Consent withdrawn by subject
    1
    4
         Adverse events
    2
    9
         Other un-specified
    1
    -
         Lost to follow-up
    1
    2
         Randomized, not treated
    1
    1
         Protocol deviation
    3
    1
         Lack of efficacy
    -
    2
    Period 2
    Period 2 title
    Extended Treatment Period(Week 16 to 52)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MSB11022 (Extended Treatment Period)
    Arm description
    		 Subjects who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MSB11022
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who received MSB11022 during core treatment period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

    Arm title
    		 EU-Humira/EU-Humira
    Arm description
    		 Subjects who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EU-Humira
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who received EU-Humira in core treatment period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.

    Arm title
    		 EU-Humira/MSB11022
    Arm description
    		 Subjects who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MSB11022
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who received EU-Humira in core treatment period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

    Number of subjects in period 2
    		MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Started
    213
    101
    101
    Completed
    195
    90
    90
    Not completed
    18
    11
    11
         Consent withdrawn by subject
    3
    2
    2
         Adverse events
    8
    6
    4
         Other un-specified
    1
    -
    1
         Lost to follow-up
    -
    1
    1
         Lack of efficacy
    4
    2
    2
         Protocol deviation
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MSB11022 (Core Treatment Period)
    Reporting group description
    		 Subjects received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

    Reporting group title
    EU-Humira
    Reporting group description
    		 Subjects received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

    Reporting group values
    		 MSB11022 (Core Treatment Period) EU-Humira Total
    Number of subjects
    		 222 221 443
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.5 ( 12.8 ) 42.7 ( 12.0 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 75 73 148
        Male
    		 147 148 295
    Race
    Units: Subjects
        White
    		 205 200 405
        Black or African American
    		 2 1 3
        Asian
    		 5 9 14
        American Indian or Alaska Native
    		 10 8 18
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Other
    		 0 1 1
        Missing/Not collected at this site
    		 0 2 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 23 23 46
        Not Hispanic or Latino
    		 199 196 395
        Missing
    		 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    MSB11022 (Core Treatment Period)
    Reporting group description
    		 Subjects received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

    Reporting group title
    EU-Humira
    Reporting group description
    		 Subjects received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
    Reporting group title
    MSB11022 (Extended Treatment Period)
    Reporting group description
    		 Subjects who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

    Reporting group title
    EU-Humira/EU-Humira
    Reporting group description
    		 Subjects who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.

    Reporting group title
    EU-Humira/MSB11022
    Reporting group description
    		 Subjects who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

    Subject analysis set title
    MSB11022 (Overall Treatment Period)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 1 up to and including Week 50 in overall treatment period.

    Subject analysis set title
    EU-Humira/EU-Humira (Overall Treatment Period)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received EU-Humira up to Week 16 continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in overall treatment period.

    Subject analysis set title
    EU-Humira/MSB11022 (Overall Treatment Period)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received EU-Humira up to Week 16 were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in overall treatment period.

    Primary: Percentage of Subjects Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of subjects who achieved at least a 75% improvement in PASI score from Baseline. The per-protocol (PP) Analysis Set included all randomized and treated subjects who did not have any major protocol deviations during the Core Treatment Period with respect to factors likely to affect the efficacy of treatment.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Percentage of Subjects
        number (not applicable)
    89.7
    91.6
    Statistical analysis title
    		 Percentage of Subjects With PASI-75
    Comparison groups
    MSB11022 (Core Treatment Period) v EU-Humira
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Percentage difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.82
         upper limit
    		 4.07
    Notes
    [1] - MSB11022 was considered equivalent to EU-Humira if the 95% stratified Newcombe Confidence Interval (CI) for the difference in percentage was included in the equivalence interval (-18, 18).

    Secondary: Percent Change From Baseline in PASI at Week 16

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    End point title
    		 Percent Change From Baseline in PASI at Week 16
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Percent change from Baseline in PASI score was reported. The PP Analysis set was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period), Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Percent change
        arithmetic mean (standard deviation)
    -90.6 ( 11.3 )
    -91.7 ( 9.9 )
    Statistical analysis title
    		 Percent change from Baseline in PASI at Week 16
    Comparison groups
    MSB11022 (Core Treatment Period) v EU-Humira
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Least Square (LS) Mean difference
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 2.98
    Notes
    [2] - MSB11022 was considered equivalent to EU-Humira if the 95% CI for the treatment difference was included in the equivalence interval [-15%, 15%]).

    Secondary: Percentage of Subjects Who Achieved PASI 50, 90 and 100 at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved PASI 50, 90 and 100 at Week 16
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 50, 90 and 100 response rate at Week 16 is measured as the percentage of subjects who achieved at least 50, 90 and 100% improvement from baseline PASI score at Week 16. PP analysis set was used.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Percentage of Subjects
    number (not applicable)
        PASI 50
    100.0
    100.0
        PASI 90
    64.0
    66.0
        PASI 100
    33.0
    37.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved PASI 50, 75, 90 and 100 at Week 24

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    End point title
    		 Percentage of Subjects Who Achieved PASI 50, 75, 90 and 100 at Week 24
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 75 response rate at Week 24 is measured as the percentage of subjects who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 24. The ETP-PP Analysis Set included subjects who were in PP Analysis Set & were re-randomized & received treatment in Extended Treatment Period. Here "Number of subjects analyzed" signifies those who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    200
    94
    92
    Units: Percentage of Subjects
    number (not applicable)
        PASI 50
    100.0
    98.9
    100.0
        PASI 75
    92.5
    88.3
    94.6
        PASI 90
    74.0
    78.7
    80.4
        PASI 100
    42.5
    37.2
    35.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved PASI 50, 75, 90 and 100 at Week 52

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    End point title
    		 Percentage of Subjects Who Achieved PASI 50, 75, 90 and 100 at Week 52
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 90 response rate at Week 52 is measured as the percentage of subjects who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 52. The ETP-PP Analysis Set was used. Here "Number of subjects analyzed" signifies those who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    186
    85
    87
    Units: Percentage of Subjects
    number (not applicable)
        PASI 50
    97.8
    100.0
    100.0
        PASI 75
    90.9
    92.9
    93.1
        PASI 90
    76.3
    78.8
    85.1
        PASI 100
    53.8
    54.1
    57.5
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change from Baseline in Physician’s Global Assessment (PGA) Score to “Clear” or “Almost Clear” at Week 16

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    End point title
    		 Number of Subjects With Change from Baseline in Physician’s Global Assessment (PGA) Score to “Clear” or “Almost Clear” at Week 16
    End point description
    PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates Clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates Mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates Moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates Severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). PP Analysis set was used. Number of subjects with PGA response of Clear or Almost clear at Week 16 were presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period), Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Subjects
    number (not applicable)
        Baseline: Moderate; Week 16: Clear
    52
    51
        Baseline: Moderate; Week 16: Almost clear
    76
    59
        Baseline: Severe; Week 16: Clear
    16
    20
        Baseline: Severe; Week 16: Almost clear
    27
    26
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in PASI at Week 24 and 52

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    End point title
    		 Percent Change From Baseline in PASI at Week 24 and 52
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. The ETP-PP analysis set was used. Here "n" Signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Extended Treatment Period), Weeks 24 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    203
    95
    96
    Units: Percent change
    geometric mean (standard deviation)
        Week 24 (n= 200, 94, 92)
    -92.9 ( 9.9 )
    -91.3 ( 12.7 )
    -94.2 ( 8.2 )
        Week 52 (n= 186, 85, 87)
    -92.8 ( 13.6 )
    -93.9 ( 9.6 )
    -94.8 ( 9.7 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change from Baseline in Physician’s Global Assessment (PGA) Score to “Clear” or “Almost Clear” at Week 24 and 52

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    End point title
    		 Number of Subjects With Change from Baseline in Physician’s Global Assessment (PGA) Score to “Clear” or “Almost Clear” at Week 24 and 52
    End point description
    PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). ETP-PP Analysis set was used. Here "n" indicates number of subjects who we evaluable for this endpoint at specified category. Number of subjects with PGA response of Clear or Almost clear at Week 16 were presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Extended Treatment Period), Week 24 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    203
    95
    96
    Units: Subjects
    number (not applicable)
        Baseline: Moderate; Week 24: Clear (n= 200,94,92)
    69
    25
    25
        Baseline:Moderate;Week 24:AlmostClear(n=200,94,92)
    52
    24
    31
        Baseline: Severe; Week 24: Clear (n= 200,94,92)
    18
    11
    9
        Baseline:Severe; Week 24:Almost Clear(n=200,94,92)
    27
    14
    13
        Baseline: Moderate; Week 52: Clear (n=188,85,87)
    74
    29
    34
        Baseline:Moderate;Week 52:AlmostClear(n=188,85,87)
    40
    13
    16
        Baseline: Severe; Week 52: Clear (n=188,85,87)
    29
    17
    16
        Baseline:Severe; Week 52:Almost Clear(n=188,85,87)
    15
    6
    6
    No statistical analyses for this end point

    Secondary: Time to achieve PASI 50

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    End point title
    		 Time to achieve PASI 50
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 50% improvement in PASI from baseline was measured. PP analysis set was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to Month 4
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Months
        median (full range (min-max))
    1.6 (0.2 to 3.7)
    1.6 (0.2 to 3.5)
    No statistical analyses for this end point

    Secondary: Time to achieve PASI 90

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    End point title
    		 Time to achieve PASI 90
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 90% improvement in PASI from baseline was measured. PP analysis set was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to Month 4
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Months
        median (full range (min-max))
    3.4 (0.7 to 3.5)
    2.6 (1.4 to 3.7)
    No statistical analyses for this end point

    Secondary: Time to achieve PASI 75

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    End point title
    		 Time to achieve PASI 75
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 75% improvement in PASI from baseline was measured. PP analysis set was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to Month 4
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Months
        median (full range (min-max))
    2.5 (0.2 to 3.5)
    1.7 (0.7 to 3.7)
    No statistical analyses for this end point

    Secondary: Time to achieve PASI 100

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    End point title
    		 Time to achieve PASI 100
    End point description
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 100% improvement in PASI from baseline was measured. PP analysis set was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to Month 13.5
    End point values
    		 MSB11022 (Overall Treatment Period) EU-Humira/EU-Humira (Overall Treatment Period) EU-Humira/MSB11022 (Overall Treatment Period)
    Number of subjects analysed
    203
    95
    96
    Units: Month
        median (full range (min-max))
    7.2 (0.7 to 11.8)
    7.2 (1.6 to 11.8)
    8.9 (1.6 to 11.8)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Meaningful Differences in Laboratory Values

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    End point title
    		 Number of Subjects with Clinically Meaningful Differences in Laboratory Values
    End point description
    Based on categories of low, normal, or high according to the laboratory normal ranges, there were no clinically meaningful differences across the treatment groups in the numbers of subjects with shifts in Laboratory parameters including hematology, chemistry and urinalysis from normal at Core Baseline to either low or high during the overall treatment period. Clinical meaningful was determined by the investigator. Safety Analysis Set (SAF) included all randomized subjects who received at least 1 dose of MSB11022 or EU-approved Humira in the Core Treatment Period, up to Week 16. Subjects in the Safety Analysis Set were analyzed according to the actual treatment received initially during the relevant treatment period. The ETP-SAF was all re-randomized subjects who received at least 1 dose of MSB11022 or EU-approved Humira in the Extended Treatment Period.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to 16; Baseline (Extended Treatment Period) up to Week 54
    End point values
    		 MSB11022 (Core Treatment Period) MSB11022 (Extended Treatment Period) EU-Humira EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    222
    213
    221
    101
    101
    Units: Subjects
        Laboratory Values
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Meaningful Differences in Vital Signs

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    End point title
    		 Number of Subjects with Clinically Meaningful Differences in Vital Signs
    End point description
    Number of subjects with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator. Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to 16; Baseline (Extended Treatment Period) up to Week 54
    End point values
    		 MSB11022 (Core Treatment Period) MSB11022 (Extended Treatment Period) EU-Humira EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    222
    213
    221
    101
    101
    Units: Subjects
        Vital signs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)

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    End point title
    		 Number of Subjects with Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)
    End point description
    Number of subjects with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator. Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to 16; Baseline (Extended Treatment Period) up to Week 54
    End point values
    		 MSB11022 (Core Treatment Period) MSB11022 (Extended Treatment Period) EU-Humira EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    222
    213
    221
    101
    101
    Units: Subjects
        12-ECG
    0
    1
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Observed Serum Concentration at Week 16

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    End point title
    		 Observed Serum Concentration at Week 16
    End point description
    The Pharmacokinetic (PK) Analysis Set included all subjects in the SAF who also had at least 1 measurable post-dose concentration.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    192
    170
    Units: Nanogram per milliliter (ng/mL)
        geometric mean (standard deviation)
    6990 ( 4504 )
    6410 ( 4152 )
    No statistical analyses for this end point

    Secondary: Observed Serum Concentration at Week 24 and 52

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    End point title
    		 Observed Serum Concentration at Week 24 and 52
    End point description
    The ETP-PK analysis included all subjects in the ETP Safety Analysis Set who had at least 1 measurable post-dose concentration in the Extended Treatment Period, without any important protocol deviations that could have impacted the quality of the PK data during the Extended Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 24 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    198
    87
    92
    Units: ng/mL
    geometric mean (standard deviation)
        Week 24 (n= 184, 86, 85)
    6240 ( 4569 )
    5870 ( 4516 )
    6430 ( 4610 )
        Week 52 (n= 161, 76, 72)
    6910 ( 5750 )
    5930 ( 4529 )
    6600 ( 5394 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change in Physician’s Global Assessment (PGA) From Baseline at Week 16

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    End point title
    		 Number of Subjects With Change in Physician’s Global Assessment (PGA) From Baseline at Week 16
    End point description
    PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). PP Analysis set was used. Only categories for which subjects recorded a PGA response were included below.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period), Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Subjects
        Baseline- Moderate; Week 16- Clear
    52
    51
        Baseline- Moderate; Week 16- Almost Clear
    76
    59
        Baseline- Moderate; Week 16- Mild
    16
    17
        Baseline- Moderate; Week 16- Moderate
    2
    1
        Baseline- Severe; Week 16- Clear
    16
    20
        Baseline- Severe; Week 16- Almost Clear
    27
    26
        Baseline- Severe; Week 16- Mild
    12
    16
        Baseline- Severe; Week 16- Moderate
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change in Physician’s Global Assessment (PGA) From Baseline at Week 24

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    End point title
    		 Number of Subjects With Change in Physician’s Global Assessment (PGA) From Baseline at Week 24
    End point description
    PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). ETP-PP Analysis set was used. Only categories for which subjects recorded a PGA response were included below.
    End point type
    Secondary
    End point timeframe
    Baseline (Extended Treatment Period), Week 24
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    200
    94
    92
    Units: Subjects
        Baseline- Moderate; Week 24- Clear
    69
    25
    25
        Baseline- Moderate; Week 24- Almost Clear
    52
    24
    31
        Baseline- Moderate; Week 24- Mild
    21
    10
    7
        Baseline- Moderate; Week 24- Moderate
    2
    2
    0
        Baseline- Severe; Week 24- Clear
    18
    11
    9
        Baseline- Severe; Week 24- Almost Clear
    27
    14
    13
        Baseline- Severe; Week 24- Mild
    9
    6
    6
        Baseline- Severe; Week 24- Moderate
    2
    1
    1
        Baseline- Severe; Week 24- Severe
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change in Physician’s Global Assessment (PGA) From Baseline at Week 52

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    End point title
    		 Number of Subjects With Change in Physician’s Global Assessment (PGA) From Baseline at Week 52
    End point description
    PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). ETP-PP Analysis set was used. Here "Number of subjects analyzed" signifies those who were evaluable for this endpoint. Only categories for which subjects recorded a PGA response were included below.
    End point type
    Secondary
    End point timeframe
    Baseline (Extended Treatment Period), Week 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    188
    85
    87
    Units: Subjects
        Baseline- Moderate; Week 52- Clear
    74
    29
    34
        Baseline- Moderate; Week 52- Almost Clear
    40
    13
    16
        Baseline- Moderate; Week 52- Mild
    17
    11
    6
        Baseline- Moderate; Week 52- Moderate
    4
    0
    4
        Baseline- Moderate; Week 52- Missing
    1
    0
    0
        Baseline- Severe; Week 52- Clear
    29
    17
    16
        Baseline- Severe; Week 52- Almost Clear
    15
    6
    6
        Baseline- Severe; Week 52- Mild
    3
    7
    3
        Baseline- Severe; Week 52- Moderate
    3
    2
    2
        Baseline- Severe; Week 52- Severe
    1
    0
    0
        Baseline- Severe; Week 52- Missing
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Dermatology Life Quality Index (DLQI) at Week 16

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    End point title
    		 Dermatology Life Quality Index (DLQI) at Week 16
    End point description
    The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much subject's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life). PP analysis set was used. Here "Number of subjects analysed" signifies those who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Weeks 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    203
    191
    Units: Units on a scale
        arithmetic mean (standard deviation)
    2.4 ( 3.2 )
    2.5 ( 3.7 )
    No statistical analyses for this end point

    Secondary: Dermatology Life Quality Index (DLQI) at Week 24 and 52

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    End point title
    		 Dermatology Life Quality Index (DLQI) at Week 24 and 52
    End point description
    The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much subject's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life). ETP-PP analysis set was used. Here "Number of subjects analysed" signifies those who ere evaluable for this endpoint and "n" signifies number of subjects who were evaluable for this endpoint at specified category.
    End point type
    Secondary
    End point timeframe
    Week 24 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    203
    95
    96
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 24 (n= 200, 94, 92)
    2.5 ( 4.1 )
    2.3 ( 4.0 )
    2.3 ( 3.9 )
        Week 52 (n= 186, 85, 86)
    3.0 ( 4.7 )
    2.1 ( 3.5 )
    2.7 ( 4.0 )
    No statistical analyses for this end point

    Secondary: European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16

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    End point title
    		 European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16
    End point description
    The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The subject was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state). PP analysis set was used. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    189
    179
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.9 ( 0.1 )
    0.9 ( 0.1 )
    No statistical analyses for this end point

    Secondary: European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52

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    End point title
    		 European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52
    End point description
    The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The subject was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state). ETP-PP analysis set was used. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint and "n" signifies those subjects who were evaluable for this endpoint at specified category.
    End point type
    Secondary
    End point timeframe
    Week 24 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    203
    95
    96
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 24 (n= 200, 94, 92)
    0.8 ( 0.1 )
    0.9 ( 0.1 )
    0.9 ( 0.1 )
        Week 52 (n= 186, 85, 86)
    0.9 ( 0.1 )
    0.9 ( 0.1 )
    0.8 ( 0.1 )
    No statistical analyses for this end point

    Secondary: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16

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    End point title
    		 Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16
    End point description
    HAQ-DI: subject-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. PP analysis set was used. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    19
    21
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.3 ( 0.4 )
    0.3 ( 0.4 )
    No statistical analyses for this end point

    Secondary: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52

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    End point title
    		 Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52
    End point description
    HAQ-DI: subject-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. ETP-PP analysis set was used. Here "n" signifies those subjects who were evaluable for this endpoint at specified category.
    End point type
    Secondary
    End point timeframe
    Week 24 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    203
    95
    96
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 24 (n= 18, 8, 10)
    0.3 ( 0.4 )
    0.2 ( 0.5 )
    0.4 ( 0.3 )
        Week 52 (n= 18, 7, 10)
    0.3 ( 0.4 )
    0.1 ( 0.2 )
    0.5 ( 0.3 )
    No statistical analyses for this end point

    Secondary: Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16

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    End point title
    		 Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16
    End point description
    Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain. PP analysis set was used. Here "Number of subjects analyzed" signifies subjects who were evaluable for this endpoint at specified category.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    19
    21
    Units: millimeter (mm)
        arithmetic mean (standard deviation)
    26.9 ( 28.3 )
    24.6 ( 24.3 )
    No statistical analyses for this end point

    Secondary: Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52

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    End point title
    		 Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52
    End point description
    Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain. ETP-PP analysis set was used. Here "n" signifies subjects who were evaluable for this endpoint at specified category.
    End point type
    Secondary
    End point timeframe
    Week 24 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    203
    95
    96
    Units: mm
    arithmetic mean (standard deviation)
        Week 24 (n= 18, 8, 10)
    29.7 ( 25.3 )
    20.6 ( 27.1 )
    24.9 ( 20.5 )
        Week 52 (n= 18, 7, 10)
    25.0 ( 20.3 )
    14.7 ( 16.5 )
    29.5 ( 19.6 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16

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    End point title
    		 Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16
    End point description
    Number of Subjects With treatment emergent Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab were reported from baseline to week 16. SAF analysis set was used. Here "Number of subjects analyzed" signifies those who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    213
    202
    Units: Subjects
    number (not applicable)
        Subjects with ADAs (n= 213, 202)
    186
    179
        Subjects with Neutralizing Abs (n= 186, 179)
    70
    70
    No statistical analyses for this end point

    Secondary: Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52

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    End point title
    		 Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52
    End point description
    Number of Subjects With positive treatment emergent Anti-Drug Antibodies (ADAs) and positive Neutralizing Antibodies (NAbs) to Adalimumab were reported. ETP-SAF analysis set was used. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint and "n" signifies subjects who were evaluable for this endpoint at specified category.
    End point type
    Secondary
    End point timeframe
    Baseline (Extended Treatment Period), Week 24, 32, 40 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    213
    101
    101
    Units: Subjects
    number (not applicable)
        Week 24: ADAs (n= 208, 96, 97)
    185
    89
    90
        Week 32: ADAs (n= 200, 90, 96)
    170
    78
    85
        Week 40: ADAs (n= 197, 89, 92)
    161
    72
    80
        Week 52: ADAs (n= 194, 87, 87)
    162
    68
    77
        Week 24: NAb (n= 185, 89, 90)
    78
    42
    39
        Week 32: NAb (n= 170, 78, 85)
    67
    30
    32
        Week 40: NAb (n= 160, 72, 80)
    70
    29
    28
        Week 52: NAb (n= 162, 68, 77)
    63
    29
    30
    No statistical analyses for this end point

    Secondary: Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16

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    End point title
    		 Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16
    End point description
    Anti-Drug Antibodies (ADAs) Titers for adalimumab up to week 16 was reported. SAF analysis set was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    222
    221
    Units: Titers
        median (full range (min-max))
    8.0 (1 to 2048)
    8.0 (1 to 1024)
    No statistical analyses for this end point

    Secondary: Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52

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    End point title
    		 Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52
    End point description
    Anti-Drug Antibodies (ADAs) Titers for adalimumab up at Week 24, 32, 40 and 50 was reported. ETP-SAF analysis set was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Extended Treatment Period), Week 24, 32, 40 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    213
    101
    101
    Units: Titers
    median (full range (min-max))
        Week 24 (n= 185, 89, 90)
    16.0 (1 to 4096)
    16.0 (1 to 4096)
    16.0 (1 to 4096)
        Week 32 (n= 170, 78, 85)
    16.0 (1 to 1024)
    16.0 (1 to 8192)
    16.0 (1 to 16384)
        Week 40 (n= 161, 72, 80)
    16.0 (1 to 8192)
    16.0 (1 to 8192)
    16.0 (1 to 16384)
        Week 52 (n= 162, 68, 77)
    8.0 (1 to 4096)
    16.0 (1 to 4096)
    8.0 (1 to 4096)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonuclic Acid (Anti-dsDNA) Assessments at week 16

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    End point title
    		 Number of Subjects with Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonuclic Acid (Anti-dsDNA) Assessments at week 16
    End point description
    Number of subjects ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any subject with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any subject with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL. Safety analysis set was used. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    221
    220
    Units: Subjects
    number (not applicable)
        Subjects with Nagative ANA values
    205
    190
        Subjects with Positive ANA values
    6
    10
        Subjects with Nagative anti-ds DNA values
    201
    186
        Subjects with Intermediate anti-ds DNA values
    4
    5
        Subjects with Positive anti-ds DNA values
    4
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects with Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonuclic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52

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    End point title
    		 Number of Subjects with Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonuclic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52
    End point description
    Number of subjects ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any subject with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any subject with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL. ETP-SAF was used. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline (Extended Treatment Period), Week 24, 32, 40 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    213
    101
    101
    Units: Subjects
    number (not applicable)
        Week 24: Negative ANA: (n= 201, 94, 97)
    188
    89
    92
        Week 32: Negative ANA: (n= 199, 88, 95)
    186
    85
    88
        Week 40: Negative ANA: (n= 196, 91, 92)
    178
    85
    85
        Week 52: Negative ANA: (n= 193, 87, 87)
    185
    84
    79
        Week 24: Positive ANA: (n= 201, 94, 97)
    13
    5
    5
        Week 32: Positive ANA: (n= 199, 88, 95)
    13
    3
    7
        Week 40: Positive ANA: (n= 196, 91, 92)
    18
    6
    7
        Week 52: Positive ANA: (n= 193, 87, 87)
    8
    3
    8
        Week 24: Negative anti-dsDNA: (n= 202, 95, 94)
    191
    89
    88
        Week 32: Negative anti-dsDNA: (n= 199, 88, 93)
    184
    83
    86
        Week 40: Negative anti-dsDNA: (n= 196, 91, 92)
    179
    86
    84
        Week 52: Negative anti-dsDNA: (n= 192, 87, 88)
    173
    81
    79
        Week 24: Positive anti-dsDNA: (n= 202, 95, 94)
    8
    3
    5
        Week 32: Positive anti-dsDNA: (n= 199, 88, 93)
    8
    3
    5
        Week 40: Positive anti-dsDNA: (n= 196, 91, 92)
    10
    3
    7
        Week 52: Positive anti-dsDNA: (n= 192, 87, 88)
    11
    2
    7
        Week 24: Intermediate anti-dsDNA: (n= 202, 95, 94)
    3
    3
    1
        Week 32: Intermediate anti-dsDNA: (n= 199, 88, 93)
    7
    2
    2
        Week 40: Intermediate anti-dsDNA: (n= 196, 91, 92)
    7
    2
    1
        Week 52: Intermediate anti-dsDNA: (n= 192, 87, 88)
    8
    4
    2
    No statistical analyses for this end point

    Secondary: European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 16

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    End point title
    		 European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 16
    End point description
    The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The subject was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the subject was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. PP analysis set was used. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint and "n" signifies those subjects who were evaluable for this endpoint at specified category.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    189
    179
    Units: Units on a scale
        arithmetic mean (standard deviation)
    81.9 ( 13.9 )
    83.1 ( 15.0 )
    No statistical analyses for this end point

    Secondary: European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52

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    End point title
    		 European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52
    End point description
    The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The subject was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the subject was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. ETP-PP analysis set was used. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint and "n" signifies those subjects who were evaluable for this endpoint at specified category.
    End point type
    Secondary
    End point timeframe
    Week 24 and 52
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    203
    95
    96
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 24 (n= 200, 94, 92)
    83.2 ( 14.2 )
    84.2 ( 13.7 )
    84.3 ( 13.9 )
        Week 52 (n= 186, 85, 86)
    83.5 ( 15.5 )
    85.1 ( 13.2 )
    82.1 ( 16.1 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16
    End point description
    Adverse event(AE) was defined as any untoward medical occurrence in subject which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. Safety (SAF) Analysis Set was all randomized subjects who received at least 1 dose of MSB11022 or EU-Humira. Subjects in SAF were analyzed according to actual treatment received initially during the relevant treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline (Core Treatment Period) up to Week 16
    End point values
    		 MSB11022 (Core Treatment Period) EU-Humira
    Number of subjects analysed
    221
    220
    Units: Subjects
    number (not applicable)
        Subjects with TEAEs
    114
    117
        Subjects with Serious TEAEs
    8
    6
        Subjects with TEAEs of special interest
    2
    3
        Subjects with TEAEs Leading to Death
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54
    End point description
    Adverse event(AE) was defined as any untoward medical occurrence in subject which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. ETP-SAF Analysis Set was used. Subjects in SAF were analyzed according to actual treatment received initially during the relevant treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline (Extended Treatment Period) up to Week 54
    End point values
    		 MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Number of subjects analysed
    213
    101
    101
    Units: Subjects
    number (not applicable)
        Subjects with TEAEs
    142
    65
    63
        Subjects with Serious TEAEs
    12
    3
    4
        Subjects with TEAEs of special interest
    10
    1
    4
        Subjects with TEAEs Leading to Death
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (Core Treatment Period) up to Week 16; Baseline (Extended Treatment Period) up to Week 54
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    MSB11022 (Core Treatment Period)
    Reporting group description
    		 Subjects received MSB11022 subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

    Reporting group title
    EU-Humira
    Reporting group description
    		 Subjects received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

    Reporting group title
    MSB11022 (Extended Treatment Period)
    Reporting group description
    		 Subjects who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

    Reporting group title
    EU-Humira/EU-Humira
    Reporting group description
    		 Subjects who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.

    Reporting group title
    EU-Humira/MSB11022
    Reporting group description
    		 Subjects who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

    Serious adverse events
    		 MSB11022 (Core Treatment Period) EU-Humira MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 221 (3.62%)
    6 / 220 (2.73%)
    12 / 213 (5.63%)
    3 / 101 (2.97%)
    4 / 101 (3.96%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 220 (0.45%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular compression
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hernia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 220 (0.45%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 220 (0.45%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 220 (0.45%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    2 / 101 (1.98%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive cardiomyopathy
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 220 (0.45%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Conjunctival cyst
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema multiforme
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity vasculitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 220 (0.45%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    1 / 213 (0.47%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    0 / 213 (0.00%)
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MSB11022 (Core Treatment Period) EU-Humira MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 221 (13.57%)
    34 / 220 (15.45%)
    59 / 213 (27.70%)
    32 / 101 (31.68%)
    25 / 101 (24.75%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    11 / 221 (4.98%)
    13 / 220 (5.91%)
    9 / 213 (4.23%)
    5 / 101 (4.95%)
    6 / 101 (5.94%)
         occurrences all number
    18
    19
    19
    25
    31
    Injection site pain
         subjects affected / exposed
    11 / 221 (4.98%)
    11 / 220 (5.00%)
    12 / 213 (5.63%)
    4 / 101 (3.96%)
    5 / 101 (4.95%)
         occurrences all number
    52
    28
    54
    4
    18
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    11 / 213 (5.16%)
    10 / 101 (9.90%)
    3 / 101 (2.97%)
         occurrences all number
    0
    0
    12
    11
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 221 (5.88%)
    15 / 220 (6.82%)
    31 / 213 (14.55%)
    12 / 101 (11.88%)
    16 / 101 (15.84%)
         occurrences all number
    13
    16
    36
    14
    16
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 220 (0.00%)
    11 / 213 (5.16%)
    5 / 101 (4.95%)
    4 / 101 (3.96%)
         occurrences all number
    0
    0
    15
    7
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Feb 2016
    1. Added 4-month Safety Evaluation visit in synopsis section and schedule of assessments section. 2. Specified procedures for subjects who become QuantiFERON®-TB Gold test (QFT) positive at Weeks 24 or 52 3. Added safety monitoring committee in early termination visit section 7.4.1
    21 Apr 2016
    1. Added of planned Week 24 analysis. 2. Observation period added following second and third injection, in-line with first injection in overall trial design and plan. 3. Subjects will be excluded if they have a body weight greater than (>) 120 kilogram instead of Body Mass Index greater than or equals to (>=) 30 kilogram per square meter (kg/m^2). 4. Added more detailed time frame in inclusion criteria. 5. Addedof AST >3^ULN as exclusion for LTBI positive subjects. 6. Removed efficacy assessments during the safety follow-up period.
    16 Sep 2016
    1. Updated the list of abbreviations. 2. Updated the sample size. 3. Clarified of the PK analysis subgroup. 4. Concomitant medicines and procedures were removed from 4-month safety follow-up visit. 5. Updated the timing of vital sign measurements updated. 6. Clarified the use of immunogenicity blood samples for PK analysis

    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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