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    Clinical Trial Results:
    A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-1420 Versus Humira® in Subjects With Chronic Plaque Psoriasis (PsOsim)

    Summary
    EudraCT number
    		 2015-000632-15
    Trial protocol
    		 LV   IT   SK   EE   PL   HR  
    Global end of trial date
    13 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2019
    First version publication date
    07 Aug 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CHS-1420-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND Number: 119540
    Sponsors
    Sponsor organisation name
    Coherus BioSciences, Inc.
    Sponsor organisation address
    333 Twin Dolphin Drive, Suit 600, Redwood City, CA, United States, 94065
    Public contact
    Barbara K. Finck, MD Chief Clinical Advisor, Coherus BioSciences, Inc., 001 650649-3530, clinicaltrialregistries@coherus.com
    Scientific contact
    Barbara K. Finck, MD Chief Clinical Advisor, Coherus BioSciences, Inc., 001 650649-3530, clinicaltrialregistries@coherus.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
    27 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the efficacy (measured by the Psoriasis Area and Severity Index [PASI]) and safety of CHS-1420 and Humira at 12 weeks in subjects with moderate to severe chronic psoriasis .
    Protection of trial subjects
    The study was conducted in accordance with the International Conference on Harmonisation, Good Clinical Practice, the Declaration of Helsinki, and with all applicable laws and regulations of the sites and countries where the study was conducted. The rationale of the study, procedural details, and investigational goals were explained to each subject, along with potential risks and benefits. Each subject was assured of his/her right to withdraw from the study at any time for any reason. Prior to the initiation of any study procedures, each subject signed and dated an approved ICF. The original was kept on file by the Investigator with the subject’s records, and a copy was given to each subject.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 125
    Country: Number of subjects enrolled
    Slovakia: 5
    Country: Number of subjects enrolled
    Croatia: 5
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    Estonia: 10
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Latvia: 21
    Country: Number of subjects enrolled
    Georgia: 18
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Moldova, Republic of: 9
    Country: Number of subjects enrolled
    Canada: 30
    Country: Number of subjects enrolled
    Chile: 9
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    South Africa: 41
    Country: Number of subjects enrolled
    Ukraine: 122
    Country: Number of subjects enrolled
    United States: 120
    Worldwide total number of subjects
    545
    EEA total number of subjects
    175
    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)
    507
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects with a diagnosis of chronic PsO for at least 6 months prior to Screening and must have moderate to severe chronic PsO as defined at Screening by PASI score of ≥12; Physician’s Static Global Assessment (PSGA) score ≥3 (based on a scale of 0 to 5); and body surface area affected by chronic PsO of ≥10%.

    Period 1
    Period 1 title
    Treatment Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Subjects, Investigators, sites staff and all personnel involved in the conduct of the study remained blinded to the subjects’ treatment assignment until all subjects completed the blinded portion of the study and the database was locked. Individual subject treatment assignment could be unblinded in the case of an unexpected SAE that required knowledge of the study drug received by the subject in order to provide appropriate treatment or management of the adverse event.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CHS-1420
    Arm description
    		 Subjects randomized to receive CHS-1420 in Treatment Period 1 after meeting the inclusion/exclusion criteria.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CHS-1420
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 2 subcutaneous (SC) injections (2 prefilled syringes [80 mg]) of CHS-1420 on Week 0/Day 0 followed by a single SC injection (1 prefilled syringe [40 mg]) of CHS-1420 every other week from Week 1/Day 7 through Week 15/Day 105.

    Arm title
    		 Humira
    Arm description
    		 Subjects randomized to receive Humira in Treatment Period 1 after meeting the inclusion/exclusion criteria..
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two SC injections (2 prefilled syringes [80 mg]) of Humira were administered on Week 0/Day 0. From Week 1/Day 7 through up to Week 47/Day 329, 1 SC injection (1 prefilled syringe [40 mg]) of Humira was administered QOW.

    Number of subjects in period 1
    		CHS-1420 Humira
    Started
    274
    271
    Completed
    259
    257
    Not completed
    15
    14
         Sponsor's decision
    2
    -
         Investigator's decision
    1
    -
         Consent withdrawn by subject
    8
    9
         Adverse event, non-fatal
    1
    -
         Other
    1
    1
         Disease progression requiring additional therapy
    1
    1
         Lost to follow-up
    1
    3
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Subjects, Investigators, sites staff and all personnel involved in the conduct of the study remained blinded to the subjects’ treatment assignment until all subjects completed the blinded portion of the study and the database was locked. Individual subject treatment assignment could be unblinded in the case of an unexpected SAE that required knowledge of the study drug received by the subject in order to provide appropriate treatment or management of the adverse event.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CHS-1420
    Arm description
    		 In Treatment Period 2, half of the subjects assigned to Humira in Treatment Period 1 were assigned to receive CHS-1420, subjects assigned to CHS-1420 in Treatment Period 1 will continue to receive CHS-1420 and the reminder of the subjects continued on Humira.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CHS-1420
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 SC injection (1 prefilled syringe [40 mg]) of CHS-1420 was administered QOW.

    Arm title
    		 Humira/CHS-1420/CHS-1420
    Arm description
    		 Half of the subjects assigned to Humira in Treatment Period 1 continued on Humira in Period 2, or were switched from Humira to CHS-1420 and continued to receive single SC injections of study drug QOW from Week 17/Day 119 through Week 23/Day 161.
    Arm type
    		 Active comparator/Experimental/Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 SC injection (1 prefilled syringe [40 mg]) of Adalimumab was administered QOW from Week 17/Day 119 through Week 23/Day 161.

    Investigational medicinal product name
    CHS-1420
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 SC injection (1 prefilled syringe [40 mg]) of CHS-1420 was administered QOW from Week 17/Day 119 through Week 23/Day 161.

    Arm title
    		 Humira/Humira/CHS-1420
    Arm description
    		 Half of the subjects assigned to Humira in Treatment Period 1 continued on Humira in Period 2, or were switched from Humira to CHS-1420 and continued to receive single SC injections of study drug QOW from Week 17/Day 119 through Week 23/Day 161.
    Arm type
    		 Active comparator/Active comparator/Exprimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 SC injection (1 prefilled syringe [40 mg]) of Adalimumab was administered QOW from Week 17/Day 119 through Week 23/Day 161.

    Investigational medicinal product name
    CHS-1420
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 SC injection (1 prefilled syringe [40 mg]) of CHS-1420 was administered QOW.

    Number of subjects in period 2
    		CHS-1420 Humira/CHS-1420/CHS-1420 Humira/Humira/CHS-1420
    Started
    259
    128
    129
    Completed
    235
    115
    125
    Not completed
    24
    13
    4
         Sponsor's decision
    2
    1
    -
         Consent withdrawn by subject
    7
    3
    1
         Active TB or a positive QuantiFERON-TB Gold
    1
    -
    -
         Disease progression
    1
    -
    -
         Failure to complete visits or follow-up visits
    -
    1
    -
         Adverse event, non-fatal
    1
    -
    -
         Medical treatment excluded by protocol
    1
    -
    -
         Other
    9
    8
    3
         Lost to follow-up
    2
    -
    -
    Period 3
    Period 3 title
    Treatment Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 CHS-1420
    Arm description
    		 All subjects who completed Treatment Periods 1+2 and achieved at least a 50% improvement in PASI (PASI-50) score at Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CHS-1420
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All subjects received 23 weeks of open-label CHS-1420 administered QOW from Week 25/Day 185 through Week 47/Day 329.

    Number of subjects in period 3
    		CHS-1420
    Started
    475
    Completed
    438
    Not completed
    37
         Consent withdrawn by subject
    17
         Active TB or a positive QuantiFERON-TB Gold
    6
         Failure to complete visits or follow-up visits
    2
         Adverse event, non-fatal
    3
         Other
    1
         Disease progression requiring additional therapy
    2
         Required medical treatment excluded by protocol
    1
         Lost to follow-up
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CHS-1420
    Reporting group description
    		 Subjects randomized to receive CHS-1420 in Treatment Period 1 after meeting the inclusion/exclusion criteria.

    Reporting group title
    Humira
    Reporting group description
    		 Subjects randomized to receive Humira in Treatment Period 1 after meeting the inclusion/exclusion criteria..

    Reporting group values
    		 CHS-1420 Humira Total
    Number of subjects
    		 274 271 545
    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)
    		 256 251 507
        From 65-84 years
    		 18 20 38
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 82 69 151
        Male
    		 192 202 394

    End points

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    End points reporting groups
    Reporting group title
    CHS-1420
    Reporting group description
    		 Subjects randomized to receive CHS-1420 in Treatment Period 1 after meeting the inclusion/exclusion criteria.

    Reporting group title
    Humira
    Reporting group description
    		 Subjects randomized to receive Humira in Treatment Period 1 after meeting the inclusion/exclusion criteria..
    Reporting group title
    CHS-1420
    Reporting group description
    		 In Treatment Period 2, half of the subjects assigned to Humira in Treatment Period 1 were assigned to receive CHS-1420, subjects assigned to CHS-1420 in Treatment Period 1 will continue to receive CHS-1420 and the reminder of the subjects continued on Humira.

    Reporting group title
    Humira/CHS-1420/CHS-1420
    Reporting group description
    		 Half of the subjects assigned to Humira in Treatment Period 1 continued on Humira in Period 2, or were switched from Humira to CHS-1420 and continued to receive single SC injections of study drug QOW from Week 17/Day 119 through Week 23/Day 161.

    Reporting group title
    Humira/Humira/CHS-1420
    Reporting group description
    		 Half of the subjects assigned to Humira in Treatment Period 1 continued on Humira in Period 2, or were switched from Humira to CHS-1420 and continued to receive single SC injections of study drug QOW from Week 17/Day 119 through Week 23/Day 161.
    Reporting group title
    CHS-1420
    Reporting group description
    		 All subjects who completed Treatment Periods 1+2 and achieved at least a 50% improvement in PASI (PASI-50) score at Week 24.

    Primary: Improvement of 75% in PASI (PASI-75) at Week 12 relative to baseline.

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    End point title
    		 Improvement of 75% in PASI (PASI-75) at Week 12 relative to baseline.
    End point description
    The primary efficacy endpoint was PASI-75 at Week 12 relative to baseline, where baseline was the last assessment prior to beginning study drug. The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 CHS-1420 Humira
    Number of subjects analysed
    274
    271
    Units: Patients
    259
    257
    Statistical analysis title
    		 Equivalence between CHS-1420 and Humira at Week 12
    Comparison groups
    CHS-1420 v Humira
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.75
         upper limit
    		 9.21

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from Period 1 Week 0 Day 0 through the study until the end of Period 3 Week 47 Day 329.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    CHS-1420/CHS-1420/CHS-1420
    Reporting group description
    		 Treatment Periods 1+2+3 combined.

    Reporting group title
    Humira/CHS-1420/ CHS-1420
    Reporting group description
    		 Treatment Periods 1+2+3 combined.

    Reporting group title
    Humira/Humira/ CHS-1420
    Reporting group description
    		 Treatment Periods 1+2+3 combined.

    Serious adverse events
    		 CHS-1420/CHS-1420/CHS-1420 Humira/CHS-1420/ CHS-1420 Humira/Humira/ CHS-1420
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 274 (3.28%)
    9 / 134 (6.72%)
    2 / 137 (1.46%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Shock
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 274 (0.00%)
    0 / 134 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urethral
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 274 (0.00%)
    0 / 134 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 134 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 CHS-1420/CHS-1420/CHS-1420 Humira/CHS-1420/ CHS-1420 Humira/Humira/ CHS-1420
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    139 / 274 (50.73%)
    67 / 134 (50.00%)
    76 / 137 (55.47%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    10 / 274 (3.65%)
    5 / 134 (3.73%)
    6 / 137 (4.38%)
         occurrences all number
    10
    6
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    8 / 274 (2.92%)
    3 / 134 (2.24%)
    7 / 137 (5.11%)
         occurrences all number
    8
    3
    8
    Blood creatine phosphokinase increased
         subjects affected / exposed
    12 / 274 (4.38%)
    5 / 134 (3.73%)
    8 / 137 (5.84%)
         occurrences all number
    12
    6
    9
    Hepatic enzyme increased
         subjects affected / exposed
    4 / 274 (1.46%)
    0 / 134 (0.00%)
    4 / 137 (2.92%)
         occurrences all number
    4
    0
    4
    Interferon gamma release assay positive
         subjects affected / exposed
    8 / 274 (2.92%)
    4 / 134 (2.99%)
    0 / 137 (0.00%)
         occurrences all number
    8
    4
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 274 (2.19%)
    0 / 134 (0.00%)
    3 / 137 (2.19%)
         occurrences all number
    6
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 274 (5.11%)
    7 / 134 (5.22%)
    8 / 137 (5.84%)
         occurrences all number
    22
    7
    10
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    12 / 274 (4.38%)
    5 / 134 (3.73%)
    6 / 137 (4.38%)
         occurrences all number
    15
    5
    18
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 274 (1.09%)
    3 / 134 (2.24%)
    2 / 137 (1.46%)
         occurrences all number
    3
    3
    2
    Diarrhoea
         subjects affected / exposed
    4 / 274 (1.46%)
    3 / 134 (2.24%)
    2 / 137 (1.46%)
         occurrences all number
    5
    3
    2
    Nausea
         subjects affected / exposed
    1 / 274 (0.36%)
    4 / 134 (2.99%)
    0 / 137 (0.00%)
         occurrences all number
    1
    4
    0
    Vomiting
         subjects affected / exposed
    1 / 274 (0.36%)
    2 / 134 (1.49%)
    3 / 137 (2.19%)
         occurrences all number
    1
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 274 (2.92%)
    1 / 134 (0.75%)
    0 / 137 (0.00%)
         occurrences all number
    9
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    7 / 274 (2.55%)
    3 / 134 (2.24%)
    4 / 137 (2.92%)
         occurrences all number
    8
    3
    5
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    7 / 274 (2.55%)
    2 / 134 (1.49%)
    3 / 137 (2.19%)
         occurrences all number
    8
    2
    3
    Psoriasis
         subjects affected / exposed
    9 / 274 (3.28%)
    8 / 134 (5.97%)
    10 / 137 (7.30%)
         occurrences all number
    13
    11
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 274 (3.65%)
    2 / 134 (1.49%)
    2 / 137 (1.46%)
         occurrences all number
    13
    2
    2
    Back pain
         subjects affected / exposed
    4 / 274 (1.46%)
    5 / 134 (3.73%)
    5 / 137 (3.65%)
         occurrences all number
    6
    5
    6
    Pain in extremity
         subjects affected / exposed
    0 / 274 (0.00%)
    2 / 134 (1.49%)
    4 / 137 (2.92%)
         occurrences all number
    0
    2
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    7 / 274 (2.55%)
    2 / 134 (1.49%)
    3 / 137 (2.19%)
         occurrences all number
    7
    3
    3
    Gastroenteritis
         subjects affected / exposed
    2 / 274 (0.73%)
    3 / 134 (2.24%)
    1 / 137 (0.73%)
         occurrences all number
    2
    3
    1
    Influenza
         subjects affected / exposed
    9 / 274 (3.28%)
    5 / 134 (3.73%)
    7 / 137 (5.11%)
         occurrences all number
    9
    5
    8
    Nasopharyngitis
         subjects affected / exposed
    35 / 274 (12.77%)
    17 / 134 (12.69%)
    17 / 137 (12.41%)
         occurrences all number
    46
    21
    20
    Pharyngitis
         subjects affected / exposed
    6 / 274 (2.19%)
    4 / 134 (2.99%)
    1 / 137 (0.73%)
         occurrences all number
    6
    4
    1
    Respiratory tract infection viral
         subjects affected / exposed
    5 / 274 (1.82%)
    5 / 134 (3.73%)
    4 / 137 (2.92%)
         occurrences all number
    9
    5
    4
    Rhinitis
         subjects affected / exposed
    6 / 274 (2.19%)
    2 / 134 (1.49%)
    4 / 137 (2.92%)
         occurrences all number
    6
    2
    7
    Sinusitis
         subjects affected / exposed
    5 / 274 (1.82%)
    4 / 134 (2.99%)
    1 / 137 (0.73%)
         occurrences all number
    5
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    23 / 274 (8.39%)
    6 / 134 (4.48%)
    13 / 137 (9.49%)
         occurrences all number
    36
    6
    14
    Urinary tract infection
         subjects affected / exposed
    11 / 274 (4.01%)
    3 / 134 (2.24%)
    5 / 137 (3.65%)
         occurrences all number
    13
    7
    7
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 134 (0.75%)
    3 / 137 (2.19%)
         occurrences all number
    0
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2015
    Amendment - 1 -The primary reason for the protocol amendment was to add a 24-week Open-Label Extension Study (Treatment Period 3) after a subject successfully completed the original double-blind 24-week study (Treatment Periods 1+2). Text related to Treatment Period 3 was added in several places in the amended protocol, including objectives, description of the treatment period, criteria to enter, time points, procedures, and safety analysis. The study design figure was also modified to include Treatment Period 3. - Added restriction to biologics and added laser treatment in inclusion criteria. - Changed abstinence from heterosexual intercourse from 8 weeks to 5 months after taking last dose of study drug, to match EU recommendations in inclusion criteria. - Removed branded or marketed names from excluded medication names to avoid confusion between regions. - Added exclusion criteria about live vaccines to ensure that prohibited medications were in agreement with guidelines for administration of Humira. - Added percentages to clarify compliance. - Added clarification to ensure that a CXR was obtained if results were not available. - Modified adverse event outcomes to match database design. - Added text to clarify that the Sponsor would remain blinded to treatment assignments and would be informed of top line results. Apart from these, various edits were made to address administrative errors, typos, and omissions, and to improve clarity, internal document consistency, etc.

    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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