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    Clinical Trial Results:
    A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered adalimumab monotherapy in patients with active psoriatic arthritis

    Summary
    EudraCT number
    		 2015-004477-32
    Trial protocol
    		 DE   FR   AT   GB   ES   GR   SK   DK   FI   NL   CZ   PT   HU   IS   BG   LT   LV   PL   IT  
    Global end of trial date
    30 Dec 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Mar 2021
    First version publication date
    24 Dec 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457F2366
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02745080
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    30 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate that the efficacy of secukinumab monotherapy (300 mg s.c.) at Week 52 is superior to adalimumab monotherapy (40 mg s.c.), based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response:
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 33
    Country: Number of subjects enrolled
    Bulgaria: 28
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Czechia: 80
    Country: Number of subjects enrolled
    Denmark: 17
    Country: Number of subjects enrolled
    Estonia: 28
    Country: Number of subjects enrolled
    Finland: 14
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 65
    Country: Number of subjects enrolled
    Greece: 24
    Country: Number of subjects enrolled
    Hungary: 22
    Country: Number of subjects enrolled
    Iceland: 5
    Country: Number of subjects enrolled
    India: 23
    Country: Number of subjects enrolled
    Israel: 31
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Latvia: 7
    Country: Number of subjects enrolled
    Lithuania: 34
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Poland: 35
    Country: Number of subjects enrolled
    Portugal: 13
    Country: Number of subjects enrolled
    Russian Federation: 99
    Country: Number of subjects enrolled
    Slovakia: 21
    Country: Number of subjects enrolled
    Spain: 94
    Country: Number of subjects enrolled
    United Kingdom: 74
    Country: Number of subjects enrolled
    United States: 43
    Worldwide total number of subjects
    853
    EEA total number of subjects
    534
    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)
    756
    From 65 to 84 years
    97
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 161 centers in 26 countries worldwide: Australia, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Israel, Italy, South Korea, Latvia, Lithuania, The Netherlands, Poland, Portugal, Russia, Slovakia, Spain, UK and USA.

    Pre-assignment
    Screening details
    		 853 patients were randomized in a 1:1 ratio to receive secukinumab 300 mg (N=426) or adalimumab 40 mg (N=427); All randomized patients were analyzed for efficacy and safety.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 300 mg s.c.
    Arm description
    		 Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    AIN457
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300 mg s.c injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (1 x 1 mL PFS) at given visits in order to maintain the blind

    Arm title
    		 Adalimumab 40 mg s.c.
    Arm description
    		 Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (1 x 0.5 mL or 2 x 0.5 mL PFS) at given visits in order to maintain the blind

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab (40 mg) s.c. injection was available in 1 x 0.4 mL PFS and administered at Baseline followed by dosing every 2 weeks until Week 50

    Number of subjects in period 1
    		Secukinumab 300 mg s.c. Adalimumab 40 mg s.c.
    Started
    426
    427
    Completed
    371
    338
    Not completed
    55
    89
         Physician decision
    3
    -
         Consent withdrawn by subject
    22
    41
         Adverse event, non-fatal
    13
    21
         Lost to follow-up
    3
    3
         Lack of efficacy
    11
    23
         Protocol deviation
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 300 mg s.c.
    Reporting group description
    		 Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.

    Reporting group title
    Adalimumab 40 mg s.c.
    Reporting group description
    		 Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.

    Reporting group values
    		 Secukinumab 300 mg s.c. Adalimumab 40 mg s.c. Total
    Number of subjects
    		 426 427 853
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 386 370 756
        From 65-84 years
    		 40 57 97
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 48.5 ( 12.38 ) 49.5 ( 12.44 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 218 198 416
        Male
    		 208 229 437
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 16 20 36
        American Indian or Alaska Native
    		 0 1 1
        Black or African American
    		 3 2 5
        White
    		 402 391 793
        Unknown
    		 1 5 6
        Other
    		 4 8 12

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 300 mg s.c.
    Reporting group description
    		 Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.

    Reporting group title
    Adalimumab 40 mg s.c.
    Reporting group description
    		 Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.

    Primary: Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52

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    End point title
    		 Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52
    End point description
    Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The primary endpoint is the proportion of patients with monotherapy ACR20 response at Week 52 where monotherapy ACR20 response is defined as meeting the following 3 conditions: 1. achieving American College of Rheumatology 20 (ACR20) response 2. no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit) 3. no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 Secukinumab 300 mg s.c. Adalimumab 40 mg s.c.
    Number of subjects analysed
    426
    427
    Units: Percentage of Participants
        number (confidence interval 95%)
    67.4 (62.8 to 71.7)
    61.5 (56.8 to 66.0)
    Statistical analysis title
    		 ACR20 Response
    Comparison groups
    Secukinumab 300 mg s.c. v Adalimumab 40 mg s.c.
    Number of subjects included in analysis
    853
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0719
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.72

    Secondary: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52

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    End point title
    		 Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Secukinumab 300 mg s.c. Adalimumab 40 mg s.c.
    Number of subjects analysed
    215
    202
    Units: Percentage of Participants
        number (confidence interval 95%)
    65.4 (58.8 to 71.5)
    43.2 (36.5 to 50.2)
    Statistical analysis title
    		 PASI90 Response
    Comparison groups
    Secukinumab 300 mg s.c. v Adalimumab 40 mg s.c.
    Number of subjects included in analysis
    417
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.67
         upper limit
    		 3.71

    Secondary: Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52

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    End point title
    		 Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52
    End point description
    Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The secondary endpoint is the proportion of patients with monotherapy ACR50 response at Week 52 where monotherapy ACR50 response is defined as meeting the following 3 conditions: 1. achieving American College of Rheumatology 50 (ACR50) response 2. no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 52 3. no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Secukinumab 300 mg s.c. Adalimumab 40 mg s.c.
    Number of subjects analysed
    426
    427
    Units: Percentage of Participants
        number (confidence interval 95%)
    49.0 (44.3 to 53.7)
    44.8 (40.1 to 49.5)
    Statistical analysis title
    		 ACR50 Response
    Comparison groups
    Secukinumab 300 mg s.c. v Adalimumab 40 mg s.c.
    Number of subjects included in analysis
    853
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2251
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.55

    Secondary: Change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI score) at Week 52

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    End point title
    		 Change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI score) at Week 52
    End point description
    The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Secukinumab 300 mg s.c. Adalimumab 40 mg s.c.
    Number of subjects analysed
    426
    427
    Units: Unit on a scale
        least squares mean (standard error)
    -0.58 ( 0.027 )
    -0.56 ( 0.027 )
    Statistical analysis title
    		 HAQ-DI Score
    Comparison groups
    Secukinumab 300 mg s.c. v Adalimumab 40 mg s.c.
    Number of subjects included in analysis
    853
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5465
    Method
    		 Mixed models analysis
    Parameter type
    		 least squares (LS) mean change
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.038

    Secondary: Percentage of Participants Who Achieved Resolution of enthesitis at Week 52

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    End point title
    		 Percentage of Participants Who Achieved Resolution of enthesitis at Week 52
    End point description
    Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. Resolution was defined as the absence of recorded enthesitis; conducted by the study assessor.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Secukinumab 300 mg s.c. Adalimumab 40 mg s.c.
    Number of subjects analysed
    234
    264
    Units: Percentage of Participants
        number (confidence interval 95%)
    60.5 (54.1 to 66.6)
    54.2 (48.2 to 60.2)
    Statistical analysis title
    		 Resolution of Enthesitis
    Comparison groups
    Secukinumab 300 mg s.c. v Adalimumab 40 mg s.c.
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1498
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.87

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were collected from first dose of study treatment until 12 Weeks (84 days) following the last administration of study treatment, an average of 68 weeks.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 AIN457 300 mg

    Reporting group title
    Adalimumab 40 mg
    Reporting group description
    		 Adalimumab 40 mg

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 AIN457 300 mg Adalimumab 40 mg Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 426 (8.69%)
    36 / 427 (8.43%)
    73 / 853 (8.56%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Leiomyoma
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovial sarcoma
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial hypertrophy
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 426 (0.23%)
    1 / 427 (0.23%)
    2 / 853 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 426 (0.00%)
    2 / 427 (0.47%)
    2 / 853 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Alveolitis
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 426 (0.23%)
    1 / 427 (0.23%)
    2 / 853 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epicondylitis
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic neck syndrome
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VIIIth nerve injury
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 426 (0.47%)
    0 / 427 (0.00%)
    2 / 853 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Horner's syndrome
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 426 (0.47%)
    0 / 427 (0.00%)
    2 / 853 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic artery aneurysm
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perioral dermatitis
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 426 (0.23%)
    1 / 427 (0.23%)
    2 / 853 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection fungal
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mycobacterial infection
         subjects affected / exposed
    0 / 426 (0.00%)
    1 / 427 (0.23%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 426 (0.00%)
    3 / 427 (0.70%)
    3 / 853 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Puncture site abscess
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 426 (0.23%)
    0 / 427 (0.00%)
    1 / 853 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AIN457 300 mg Adalimumab 40 mg Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    226 / 426 (53.05%)
    236 / 427 (55.27%)
    462 / 853 (54.16%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    27 / 426 (6.34%)
    24 / 427 (5.62%)
    51 / 853 (5.98%)
         occurrences all number
    28
    23
    51
    Nervous system disorders
    Headache
         subjects affected / exposed
    36 / 426 (8.45%)
    33 / 427 (7.73%)
    69 / 853 (8.09%)
         occurrences all number
    49
    43
    92
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    4 / 426 (0.94%)
    28 / 427 (6.56%)
    32 / 853 (3.75%)
         occurrences all number
    5
    118
    123
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    32 / 426 (7.51%)
    37 / 427 (8.67%)
    69 / 853 (8.09%)
         occurrences all number
    40
    41
    81
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    24 / 426 (5.63%)
    14 / 427 (3.28%)
    38 / 853 (4.45%)
         occurrences all number
    27
    16
    43
    Oropharyngeal pain
         subjects affected / exposed
    25 / 426 (5.87%)
    15 / 427 (3.51%)
    40 / 853 (4.69%)
         occurrences all number
    34
    16
    50
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    33 / 426 (7.75%)
    34 / 427 (7.96%)
    67 / 853 (7.85%)
         occurrences all number
    38
    45
    83
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    29 / 426 (6.81%)
    31 / 427 (7.26%)
    60 / 853 (7.03%)
         occurrences all number
    33
    43
    76
    Back pain
         subjects affected / exposed
    17 / 426 (3.99%)
    31 / 427 (7.26%)
    48 / 853 (5.63%)
         occurrences all number
    21
    31
    52
    Psoriatic arthropathy
         subjects affected / exposed
    34 / 426 (7.98%)
    38 / 427 (8.90%)
    72 / 853 (8.44%)
         occurrences all number
    25
    35
    60
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    16 / 426 (3.76%)
    27 / 427 (6.32%)
    43 / 853 (5.04%)
         occurrences all number
    17
    28
    45
    Nasopharyngitis
         subjects affected / exposed
    88 / 426 (20.66%)
    84 / 427 (19.67%)
    172 / 853 (20.16%)
         occurrences all number
    115
    117
    232
    Upper respiratory tract infection
         subjects affected / exposed
    42 / 426 (9.86%)
    54 / 427 (12.65%)
    96 / 853 (11.25%)
         occurrences all number
    59
    65
    124

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jan 2017
    At the time of this amendment, no patients had been randomized into the study. No change to the study population was proposed by this amendment. This protocol amendment was primarily issued for the following reasons: 1) The half-life of adalimumab is reported to be approximately 2 weeks, therefore in the original protocol the safety follow-up was planned to cover 5x the half-life or approximately 10 weeks. Consequently, the safety follow-up visit was scheduled for 10 weeks after the last dose of adalimumab. 2) Exclusion Criteria 2 provided guidelines and examples where local label requirements for contraception use, after the last dose of study treatment, should be followed by women of childbearing potential. Health Authority requests stipulated that the protocol should specify contraception use for 5 months after last dose of adalimumab (see Humira® SmPC 2019).

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32386593
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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