Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized Comparative Study Assessing the Switching Between PF-06410293 And Humira® In Combination With Methotrexate In Participants With Moderately To Severely Active Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2019-000284-24
    Trial protocol
    		 CZ   LT  
    Global end of trial date
    22 Jun 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    11 Feb 2024
    First version publication date
    03 Jul 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B5381012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04230213
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    14 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate interchangeability of PF-06510293 and Humira by examining adalimumab steady-state pharmacokinetics in a switching arm (following 3 switches between Humira and PF-06410293) as compared to a non-switching arm (receiving only Humira).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jan 2020
    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
    Bosnia and Herzegovina: 35
    Country: Number of subjects enrolled
    Bulgaria: 28
    Country: Number of subjects enrolled
    Czechia: 69
    Country: Number of subjects enrolled
    Lithuania: 13
    Country: Number of subjects enrolled
    Poland: 119
    Country: Number of subjects enrolled
    Russian Federation: 46
    Country: Number of subjects enrolled
    Serbia: 37
    Country: Number of subjects enrolled
    South Africa: 21
    Country: Number of subjects enrolled
    Ukraine: 55
    Country: Number of subjects enrolled
    United States: 22
    Worldwide total number of subjects
    445
    EEA total number of subjects
    229
    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)
    369
    From 65 to 84 years
    76
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 455 subjects were enrolled in the study, of which 10 subjects were excluded from all the data analyses due to violation of GCP principles. Thus, these 10 subjects were not included in any section of results.

    Period 1
    Period 1 title
    TP1: Week 0 (Day 1) to Week 10
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Humira (Adalimumab)
    Arm description
    		 All subjects received Humira 40 milligrams (mg) once every 2 weeks subcutaneously for 10 weeks during Treatment Period 1 (TP1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab 40 mg, single subcutaneous injection in abdomen or upper front of either thigh every 2 weeks for 10 weeks.

    Number of subjects in period 1
    		Humira (Adalimumab)
    Started
    445
    Completed
    427
    Not completed
    18
         Consent withdrawn by subject
    7
         Physician decision
    3
         Unspecified
    8
    Period 2
    Period 2 title
    TP2 up to End of Study:Week 10 to 36
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Switching Arm: Humira and PF-06410293 (Adalimumab)
    Arm description
    		 Subjects after completing TP1, were randomised to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 subjects received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 subjects received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Subjects were followed for 4 weeks post last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Humira 40 mg, single subcutaneous injection in abdomen or upper front of either thigh every 2 weeks for 6 weeks during TP3.

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    PF-06410293
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PF-06410293 40 mg, single subcutaneous injection in abdomen or upper front of either thigh once every 2 weeks for 6 weeks during TP2 and for 10 weeks during TP4.

    Arm title
    		 Non-switching Arm: Humira (Adalimumab)
    Arm description
    		 Subjects after completing TP1, were randomised to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks. Subjects were followed for 4 weeks post last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Humira 40 mg, single subcutaneous injection in abdomen or upper front of either thigh every 2 weeks for 22 weeks.

    Number of subjects in period 2
    		Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Started
    213
    214
    Completed
    201
    194
    Not completed
    12
    20
         Consent withdrawn by subject
    1
    7
         Physician decision
    2
    2
         Unspecified
    9
    10
         Lost to follow-up
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Humira (Adalimumab)
    Reporting group description
    		 All subjects received Humira 40 milligrams (mg) once every 2 weeks subcutaneously for 10 weeks during Treatment Period 1 (TP1).

    Reporting group values
    		 Humira (Adalimumab) Total
    Number of subjects
    		 445 445
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 369 369
        From 65-84 years
    		 76 76
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 53.60 ± 11.17 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 368 368
        Male
    		 77 77
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 4 4
        Not Hispanic or Latino
    		 440 440
        Unknown or Not Reported
    		 1 1
    Race
    Units: Subjects
        Black or African American
    		 2 2
        White
    		 440 440
        Unknown or Not Reported
    		 3 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Humira (Adalimumab)
    Reporting group description
    		 All subjects received Humira 40 milligrams (mg) once every 2 weeks subcutaneously for 10 weeks during Treatment Period 1 (TP1).
    Reporting group title
    Switching Arm: Humira and PF-06410293 (Adalimumab)
    Reporting group description
    		 Subjects after completing TP1, were randomised to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 subjects received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 subjects received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Subjects were followed for 4 weeks post last dose.

    Reporting group title
    Non-switching Arm: Humira (Adalimumab)
    Reporting group description
    		 Subjects after completing TP1, were randomised to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks. Subjects were followed for 4 weeks post last dose.

    Primary: Maximum Observed Serum Concentration (Cmax) of Adalimumab

    		 Close Top of page
    End point title
    		 Maximum Observed Serum Concentration (Cmax) of Adalimumab
    End point description
    Cmax refers to maximum observed serum concentration of drug. Pharmacokinetic (PK) population included all randomised subjects who were dosed to initiate the Week 30 steady-state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. The geometric coefficient of variation is expressed in percentage. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint. Since time points for analysis for this endpoint were falling in TP4, hence only switching and non-switching arms data were reported.
    End point type
    Primary
    End point timeframe
    Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    194
    186
    Units: Micrograms per millilitre
        geometric mean (geometric coefficient of variation)
    9.156 ± 97
    8.974 ± 97
    Statistical analysis title
    		 Switching Arm vs. Non-switching Arm
    Statistical analysis description
    Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.
    Comparison groups
    Switching Arm: Humira and PF-06410293 (Adalimumab) v Non-switching Arm: Humira (Adalimumab)
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Geometric mean ratio (percentage)
    Point estimate
    102.56
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 89.78
         upper limit
    		 117.17
    Notes
    [1] - Analysis was performed using analysis of variance (ANOVA) model.

    Primary: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab

    		 Close Top of page
    End point title
    		 Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab
    End point description
    Area under the serum concentration curve (AUC) from time 0 to end of dosing interval (tau), where dosing interval was once every two weeks. PK population included all randomised subjects who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. The geometric coefficient of variation is expressed in percentage. Here, “Number of Subjects Analysed” signifies subjects evaluable for this end point. Since time points for analysis for this end point were falling in TP4, hence only switching and non-switching arms data were reported.
    End point type
    Primary
    End point timeframe
    Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    189
    183
    Units: Microgram*hour per millilitre
        geometric mean (geometric coefficient of variation)
    2472 ± 129
    2365 ± 133
    Statistical analysis title
    		 Switching Arm vs. Non-switching Arm
    Statistical analysis description
    Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.
    Comparison groups
    Switching Arm: Humira and PF-06410293 (Adalimumab) v Non-switching Arm: Humira (Adalimumab)
    Number of subjects included in analysis
    372
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Geometric mean ratio (Percentage)
    Point estimate
    105.31
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 89.16
         upper limit
    		 124.39
    Notes
    [2] - Analysis was performed using ANOVA model.

    Secondary: Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab

    		 Close Top of page
    End point title
    		 Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab
    End point description
    Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10. Data for Days 1 and 71 were identified retrospectively for subjects in the safety randomised population, hence included in the switching and non-switching reporting groups. Here, n signifies subjects evaluable for each specified category.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Day 1, 71,113, 155, 169, 183, 197 and 211
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Micrograms per millilitre
    arithmetic mean (standard deviation)
        Day 1 (n=213, 214)
    0.03102 ± 0.15291
    0.05703 ± 0.29719
        Day 71 (n=211, 214)
    6.999 ± 4.4196
    6.675 ± 4.3310
        Day 113 (n=210, 209)
    7.763 ± 5.0812
    7.374 ± 4.8807
        Day 155 (n=208, 200)
    7.900 ± 5.2493
    7.558 ± 5.0502
        Day 169 (n=204, 197)
    7.918 ± 5.1756
    7.767 ± 5.1860
        Day 183 (n=202,197)
    8.259 ± 5.3404
    7.933 ± 5.1299
        Day 197 (n=204, 197)
    8.347 ± 5.5458
    8.022 ± 5.2046
        Day 211 (n=206, 198)
    8.477 ± 5.4604
    7.891 ± 5.1818
    No statistical analyses for this end point

    Secondary: Apparent Clearance (CL/F) of Serum Adalimumab

    		 Close Top of page
    End point title
    		 Apparent Clearance (CL/F) of Serum Adalimumab
    End point description
    Clearance of a drug is a measure of the rate at which a drug is metabolised or eliminated by normal biological processes. CL/F was calculated as dose administered divided by area under the concentration curve from time 0 extrapolated to infinite time (AUCinf). PK population included all randomised subjects who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. The geometric coefficient of variation is expressed in percentage. Here "Number of Subjects Analysed' signifies subjects evaluable for this end point. Since time points for analysis for this end point were falling in TP4, hence only switching and non-switching arms data were reported.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    189
    183
    Units: Millilitre per hour
        geometric mean (geometric coefficient of variation)
    16.19 ± 129
    16.91 ± 133
    No statistical analyses for this end point

    Secondary: Average Serum Concentration (Cav) of Adalimumab

    		 Close Top of page
    End point title
    		 Average Serum Concentration (Cav) of Adalimumab
    End point description
    Cav was defined as average serum concentration over the dosing interval. PK population included all randomised subjects who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. The geometric coefficient of variation is expressed in percentage. Here "Number of Subjects Analysed" signifies subjects evaluable for this end point. Since time points for analysis for this end point were falling in TP4, hence only switching and non-switching arms data were reported.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    189
    183
    Units: Micrograms per millilitre
        geometric mean (geometric coefficient of variation)
    7.357 ± 130
    7.040 ± 133
    No statistical analyses for this end point

    Secondary: Time to Reach Cmax (Tmax) of Adalimumab

    		 Close Top of page
    End point title
    		 Time to Reach Cmax (Tmax) of Adalimumab
    End point description
    Tmax is the time taken (in hours) to reach the maximum serum drug concentration. PK population included all randomised subjects who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here, “Number of Subjects Analysed” signifies subjects evaluable for this end point. Since time points for analysis for this end point were falling in TP4, hence only switching and non-switching arms data were reported.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    194
    186
    Units: Hours
        median (full range (min-max))
    71.80 (0.000 to 336)
    72.00 (0.000 to 337)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1

    		 Close Top of page
    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomisation in TP2. AEs included both serious and all non-serious AEs. Safety population for TP1 included all subjects who were enrolled and received at least one dose of study treatment in TP1.
    End point type
    Secondary
    End point timeframe
    Day 1 up to maximum of 10 Weeks
    End point values
    		 Humira (Adalimumab)
    Number of subjects analysed
    445
    Units: Subjects
        TEAEs
    107
        Serious TEAEs
    13
        Treatment related TEAEs
    31
    No statistical analyses for this end point

    Secondary: Number of Subjects With Grade 3 or Higher TEAEs: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects With Grade 3 or Higher TEAEs: TP2 and Beyond
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP2 and beyond was defined as any AE that occurred after the first dose of study treatment administration after randomisation in TP2 and up to 4 weeks after last dose. AEs were graded using the Common Terminology Criteria for Adverse Events where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening consequences; urgent intervention indicated; and grade 5= death related to AE. Number of subject with grade 3 or higher TEAEs were presented. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to maximum of 4 weeks after last dose (maximum of 26 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Subjects
    5
    8
    No statistical analyses for this end point

    Secondary: Number of Subjects With Grade 3 or Higher TEAEs: TP1

    		 Close Top of page
    End point title
    		 Number of Subjects With Grade 3 or Higher TEAEs: TP1
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomisation in TP2. AEs were graded using the Common Terminology Criteria for Adverse Events where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening consequences; urgent intervention indicated; and grade 5= death related to AE. Number of subjects with grade 3 or higher TEAEs were presented. Safety population for TP1 included all subjects who were enrolled and received at least one dose of study treatment in TP1.
    End point type
    Secondary
    End point timeframe
    Day 1 up to maximum of 10 Weeks
    End point values
    		 Humira (Adalimumab)
    Number of subjects analysed
    445
    Units: Subjects
    14
    No statistical analyses for this end point

    Secondary: Number of Subjects With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose:resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation;was life-threatening;resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. TEAE for TP2 and beyond was defined as any AE that occurred after administering the first dose of study treatment after randomisation in TP2 and up to 4 weeks after last dose. AEs included both serious and all non-serious AEs. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to maximum of 4 weeks after last dose (maximum of 26 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Subjects
        TEAEs
    82
    62
        Serious TEAEs
    3
    8
        Treatment related TEAEs
    19
    10
    No statistical analyses for this end point

    Secondary: Number of Subjects who Discontinued Treatment and Study due to TEAEs: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects who Discontinued Treatment and Study due to TEAEs: TP2 and Beyond
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP2 and beyond was defined as any AE that occurred after the first dose of study treatment administration after randomisation in TP2 and up to 4 weeks after last dose. AEs included both serious and all non-serious AEs. Subjects who discontinued treatment due to TEAEs were those who had an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the subject to be discontinued from study. Subjects who discontinued from study due to TEAE were those who had an AE record indicating that the AE caused the subject to be discontinued from the study. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to maximum of 4 weeks after last dose (maximum of 26 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Subjects
        Discontinued from treatment due to TEAEs
    0
    3
        Discontinued from study due to TEAEs
    8
    9
    No statistical analyses for this end point

    Secondary: Number of Subjects who Discontinued Treatment and Study due to TEAEs: TP1

    		 Close Top of page
    End point title
    		 Number of Subjects who Discontinued Treatment and Study due to TEAEs: TP1
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomisation in TP2. Subject who discontinued treatment due to TEAEs were those who had an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the subject to be discontinued from study. Subjects who discontinued from study due to TEAE were those who had an AE record indicating that the AE caused the subject to be discontinued from the study. Safety population for TP1 included all subjects who were enrolled and received at least one dose of study treatment in TP1.
    End point type
    Secondary
    End point timeframe
    Day 1 up to maximum of 10 Weeks
    End point values
    		 Humira (Adalimumab)
    Number of subjects analysed
    445
    Units: Subjects
        Discontinued from treatment due to TEAEs
    3
        Discontinued from study due to TEAE
    12
    No statistical analyses for this end point

    Secondary: Number of Subjects With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Subjects During TP1

    		 Close Top of page
    End point title
    		 Number of Subjects With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Subjects During TP1
    End point description
    In this end point, subjects who were antidrug antibody (ADA) positive during TP1 were assessed in TP2 and beyond per visit for their ADA status at the time of start of their potential immunogenic AEs including ISRs, medically (Med) evaluated board standard MedDRA query (SMQ) of potential hypersensitivity (anaphylactic reactions, hypersensitivity and angioedema), medically evaluated AEs meeting Sampson criteria, cytokine storm and delayed immune responses (DIR). ADA positive was defined as ADA titer >=1.88. Safety randomised population included all subjects who were randomised and received at least one dose of investigational product following the randomisation at Study Week 10. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint. Here, n signifies subjects evaluable for specific rows.
    End point type
    Secondary
    End point timeframe
    TP 2 and beyond: Week (Wk) 16, 22, 24, 26, 28, 30, 32
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    55
    59
    Units: Subjects
        Wk 16: ISR;n=55,57
    0
    1
        Wk 16:Med. evaluated Sampson criteria met;n=55,57
    0
    0
        Wk 16: AEs belonging to SMQ Group;n=55,57
    0
    0
        Wk 22: ISR;n=55,55
    0
    1
        Wk 22:Med. evaluated Sampson criteria met;n=55,55
    0
    0
        Wk 22: AEs belonging to SMQ Group;n=55,55
    0
    0
        Wk 24: ISR;n=55,54
    0
    1
        Wk 24:Med. evaluated Sampson criteria met;n=55,54
    0
    0
        Wk 24: AEs belonging to SMQ Group;n=55,54
    0
    1
        Wk 26: ISR;n=54,53
    1
    1
        Wk 26:Med. evaluated Sampson criteria met;n=54,53
    0
    0
        Wk 26: AEs belonging to SMQ Group;n=54,53
    0
    0
        Wk 28: ISR;n=55,53
    0
    1
        Wk 28:Med. evaluated Sampson criteria met;n=55,53
    0
    0
        Wk 28: AEs belonging to SMQ Group;n=55,53
    0
    0
        Wk 30: ISR;n=55,54
    0
    1
        Wk 30:Med. evaluated Sampson criteria met;n=55,54
    0
    0
        Wk 30: AEs belonging to SMQ Group;n=55,54
    1
    0
        Wk 32: ISR;n=54,59
    0
    0
        Wk 32:Med. evaluated Sampson criteria met;n=54,59
    0
    0
        Wk 32: AEs belonging to SMQ Group;n=54,59
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With TEAEs of Special Interest: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects With TEAEs of Special Interest: TP2 and Beyond
    End point description
    AEs of special interest (AESI) included: hypersensitivity events (anaphylactic reaction, hypersensitivity, angioedema, delayed immune responses and injection site reactions [ISRs]); blood and lymphatic system events (white blood cell disorders and anaemias nonhaemolytic and marrow depression); cardiovascular events (cardiac failure, hypertension and myocardial infarction); demyelinating conditions, gastric/hepatic events (gastrointestinal perforation, ulceration, haemorrhage or obstruction and hepatic disorders); infections and infestations (including TB and other opportunistic infections); malignancies (neoplasms benign, malignant and unspecified [including cysts and polyps]) and lupus like syndrome. Number of subjects with any AESI were presented. Safety randomised population: all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to maximum of 4 weeks after last dose (maximum of 26 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Subjects
    58
    47
    No statistical analyses for this end point

    Secondary: Number of Subjects With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Subjects During TP1

    		 Close Top of page
    End point title
    		 Number of Subjects With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Subjects During TP1
    End point description
    In this end point, subjects who were ADA negative during TP1 were assessed in TP2 and beyond per visit for their ADA status at the time of start of their potential immunogenic AEs including ISRs, medically (Med) evaluated board SMQ of potential hypersensitivity (anaphylactic reactions, hypersensitivity and angioedema), medically evaluated AEs meeting Sampson criteria, cytokine storm and DIR. ADA negative was defined as ADA titer <1.88. Safety randomised population included all subjects who were randomised and received at least one dose of investigational product following the randomisation at Study Week 10. Here, “Number of Subjects Analysed” signifies subjects evaluable for this end point. Here, n signifies subjects evaluable for specific rows.
    End point type
    Secondary
    End point timeframe
    TP 2 and beyond: Wk 16, 22, 24, 26, 28, 30, 32
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    156
    155
    Units: Subjects
        Wk 16:ISR;n=153,152
    4
    2
        Wk 16:Med evaluated Sampson criteria met;n=153,152
    0
    0
        Wk 16:AEs belonging to SMQ Group;n=153,152
    0
    0
        Wk 22:ISR;n=151,147
    1
    1
        Wk 22:Med evaluated Sampson criteria met;n=151,147
    0
    0
        Wk 22:AEs belonging to SMQ Group;n=151,147
    0
    0
        Wk 24:ISR;n=150,145
    0
    2
        Wk 24:Med evaluated Sampson criteria met;n=150,145
    0
    0
        Wk 24: AEs belonging to SMQ Group;n=150, 145
    0
    0
        Wk 26: ISR;n=148, 145
    0
    2
        Wk 26:Med evaluated Sampson criteria met;n=148,145
    0
    0
        Wk 26:AEs belonging to SMQ Group;n=148,145
    0
    0
        Wk 28:ISR;n=148,144
    0
    1
        Wk 28:Med evaluated Sampson criteria met;n=148,144
    0
    0
        Wk 28:AEs belonging to SMQ Group;n=148,144
    0
    0
        Wk 30:ISR;n=149,144
    0
    1
        Wk 30:Med evaluated Sampson criteria met;n=149,144
    0
    0
        Wk 30:AEs belonging to SMQ Group;n=149,144
    0
    0
        Wk 32:ISR;n=152,149
    0
    1
        Wk 32:Med evaluated Sampson criteria met;n=152,149
    0
    0
        Wk 32:AEs belonging to SMQ Group;n=152,149
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With TEAEs and Serious TEAEs Related to COVID-19: TP1

    		 Close Top of page
    End point title
    		 Number of Subjects With TEAEs and Serious TEAEs Related to COVID-19: TP1
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomisation in TP2. AEs included both serious and all non-serious AEs. TEAEs and serious TEAEs related to Covid-19 as per investigator's assessment were presented. Safety population for TP1 included all subjects who were enrolled and received at least one dose of study treatment in TP1.
    End point type
    Secondary
    End point timeframe
    Day 1 up to maximum of 10 Weeks
    End point values
    		 Humira (Adalimumab)
    Number of subjects analysed
    445
    Units: Subjects
        TEAE
    10
        Serious TEAE
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects who Discontinued Treatment and Study due to TEAEs Related to COVID-19: TP1

    		 Close Top of page
    End point title
    		 Number of Subjects who Discontinued Treatment and Study due to TEAEs Related to COVID-19: TP1
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomisation in TP2. Subjects who discontinued treatment due to TEAEs were those who had an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the subject to be discontinued from study. Subjects who discontinued from study due to TEAE were those who had an AE record indicating that the AE caused the subjects to be discontinued from the study. TEAEs were related to Covid-19. Safety population for TP1 included all subjects who were enrolled and received at least one dose of study treatment in TP1.
    End point type
    Secondary
    End point timeframe
    Day 1 up to maximum of 10 Weeks
    End point values
    		 Humira (Adalimumab)
    Number of subjects analysed
    445
    Units: Subjects
        Discontinued from treatment due to TEAEs
    0
        Discontinued from study due to TEAE
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects who Discontinued Treatment and Study due to TEAEs Related to COVID-19: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects who Discontinued Treatment and Study due to TEAEs Related to COVID-19: TP2 and Beyond
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP2 and beyond was defined as any AE that occurred after the first dose of study treatment administration after randomisation in TP2 and up to 4 weeks after last dose. AEs included both serious and all non-serious AEs. Subjects who discontinued treatment due to TEAEs were those who had an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the subject to be discontinued from study. Subjects who discontinued from study due to TEAE were those who had an AE record indicating that the AE caused the subject to be discontinued from the study. TEAEs were related to Covid-19. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to maximum of 4 weeks after last dose (maximum of 26 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Subjects
        Discontinued from treatment due to TEAEs
    0
    0
        Discontinued from study due to TEAE
    3
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events. TEAE for TP2 and beyond was defined as any AE that occurred after the first dose of study treatment administration after randomisation in TP2 and up to 4 weeks after last dose. AEs included both serious and all non-serious AEs. TEAEs and serious TEAEs related to Covid-19 as per investigator's assessment were presented. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to maximum of 4 weeks after last dose (maximum of 26 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Subjects
        TEAE
    20
    16
        Serious TEAE
    1
    3
    No statistical analyses for this end point

    Secondary: Number of subjects With Haematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of subjects With Haematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond
    End point description
    Blood samples were collected for the analysis of following haematology parameters included: anaemia, haemoglobin increased, leucocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased. Laboratory parameters were graded according to National Cancer Institute-CTC version 4.03 where, Grade 0: within normal limits; Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences and Grade 5: death. Categories with at least 1 non-zero value were reported in this end point. Safety randomised population included all subjects who were randomised and received at least one dose of dose of investigational product following the randomisation at Study Week 10. Here, “Number of Subjects Analysed” signifies subjects evaluable for this end point. Here, n signifies subjects evaluable for each row.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to end of study treatment (maximum of 22 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    209
    205
    Units: Subjects
        Grade 0: Anaemia (n=209, 205)
    198
    190
        Grade 0: Haemoglobin increased (n=209, 205)
    207
    201
        Grade 0: Leucocytosis (n=209, 205)
    209
    205
        Grade 0: Lymphocyte count decreased (n=209, 205)
    204
    200
        Grade 0: Lymphocyte count increased (n=209, 205)
    203
    196
        Grade 0: Neutrophil count decreased (n=209, 204)
    198
    197
        Grade 0: Platelet count decreased (n=207, 204)
    201
    200
        Grade 0: White blood cell decreased (n=209, 205)
    202
    199
        Grade 1: Anaemia (n=209, 205)
    5
    7
        Grade 1: Haemoglobin increased (n=209, 205)
    2
    3
        Grade 1: Lymphocyte count decreased (n=209, 205)
    4
    3
        Grade 1: Neutrophil count decreased (n=209, 204)
    4
    3
        Grade 1: Platelet count decreased (n=207, 204)
    6
    4
        Grade 1: White blood cell decreased (n=209, 205)
    6
    6
        Grade 2: Anaemia (n=209, 205)
    6
    6
        Grade 2: Hemoglobin increased (n=209, 205)
    0
    1
        Grade 2: Lymphocyte count decreased (n=209, 205)
    1
    2
        Grade 2: Lymphocyte count increased (n=209, 205)
    6
    9
        Grade 2: Neutrophil count decreased (n=209, 204)
    7
    4
        Grade 2: White blood cell decreased (n=209, 205)
    1
    0
        Grade 3: Anaemia (n=209, 205)
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Abnormalities: TP1

    		 Close Top of page
    End point title
    		 Number of Subjects With Laboratory Abnormalities: TP1
    End point description
    Blood samples were collected for the analysis of following laboratory parameters: haematology parameters (haemoglobin, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular haemoglobin, erythrocyte mean corpuscular haemoglobin concentration platelet count, leukocytes, lymphocytes, neutrophils, eosinophils, monocytes); clinical chemistry parameters (bilirubin, alanine aminotransferase [ALT], blood urea nitrogen [BUN], creatinine, potassium, bicarbonate); urine parameters: urine protein, urine haemoglobin, nitrite, leukocyte esterase and bacteria. Number of subjects with any laboratory abnormalities is presented. Safety population for TP1 included all subjects who were enrolled and received at least one dose of study treatment in TP1. Here "Number of subjects Analysed" signifies subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Day 1 up to maximum of 10 Weeks
    End point values
    		 Humira (Adalimumab)
    Number of subjects analysed
    437
    Units: Subjects
    134
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Abnormalities: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects With Laboratory Abnormalities: TP2 and Beyond
    End point description
    Blood samples were collected for the analysis of following laboratory parameters: haematology parameters (haemoglobin, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular haemoglobin, erythrocyte mean corpuscular haemoglobin concentration platelet count, leukocytes, lymphocytes, neutrophils, eosinophils, monocytes); clinical chemistry parameters (bilirubin, ALT, BUN, creatinine, potassium, bicarbonate); urine parameters: urine protein, urine haemoglobin, nitrite, leukocyte esterase and bacteria. Number of subjects with any laboratory abnormalities is presented. Safety population for TP1 included all subjects who were enrolled and received at least one dose of study treatment in TP1. Safety randomised population included all subjects who were randomised and received at least one dose of dose of investigational product following the randomisation at Study Week 10. Here "Number of subjects Analysed" signifies subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to end of study treatment (maximum of 22 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    211
    208
    Units: Subjects
    71
    83
    No statistical analyses for this end point

    Secondary: Number of Subjects With Chemistry Results by Maximum CTC Grade: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects With Chemistry Results by Maximum CTC Grade: TP2 and Beyond
    End point description
    Blood samples were collected for analysis of clinical chemistry parameters: (ALT increased, alkaline phosphatase (ALP) increased , aspartate aminotransferase (AST) increased , blood bilirubin increased, creatinine increased, hypercalcemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia. Laboratory parameters were graded according to NCI-CTC version 4.03 where, grade 0= within normal limits; Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences and Grade 5: death. Categories with at least 1 non-zero value were reported in this end point. Safety randomised population included all subjects who were randomised and received at least one dose of dose of investigational product following the randomisation at Study Week 10. Here, "Number of Subjects Analysed" signifies subjects evaluable for this end point. Here, n signifies subjects evaluable for each row.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to end of study treatment (maximum of 22 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    212
    208
    Units: Subjects
        Grade 0: ALT increased (n=211, 208)
    169
    174
        Grade 0: ALP increased (n=211, 208)
    202
    196
        Grade 0: AST increased (n=211, 208)
    195
    198
        Grade 0: Blood bilirubin increased (n=211, 208)
    205
    204
        Grade 0: Creatinine increased (n=211, 208)
    171
    151
        Grade 0: Hypercalcemia (n=211, 208)
    211
    207
        Grade 0: Hyperkalaemia (n=212, 208)
    208
    202
        Grade 0: Hypernatremia (n=212, 208)
    210
    207
        Grade 0: Hypoalbuminemia (n=212, 208)
    212
    208
        Grade 0: Hypocalcemia (n=211, 208)
    201
    202
        Grade 0: Hypokalemia (n=212, 208)
    210
    207
        Grade 0: Hyponatremia (n=212, 208)
    211
    207
        Grade 1: ALT increased (n=211, 208)
    40
    33
        Grade 1: ALP increased (n=211, 208)
    9
    12
        Grade 1: AST increased (n=211, 208)
    16
    10
        Grade 1: Blood bilirubin increased (n=211, 208)
    5
    3
        Grade 1: Creatinine increased (n=211, 208)
    39
    52
        Grade 1: Hypercalcemia (n=211, 208)
    0
    1
        Grade 1: Hyperkalemia (n=212, 208)
    4
    6
        Grade 1: Hypernatremia (n=212, 208)
    2
    1
        Grade 1: Hypocalcemia (n=211, 208)
    10
    6
        Grade 1: Hyponatremia (n=212, 208)
    1
    1
        Grade 2: ALT increased (n=211, 208)
    2
    1
        Grade 2: Blood bilirubin increased (n=211, 208)
    1
    1
        Grade 2: Creatinine increased (n=211, 208)
    1
    5
        Grade 2: Hypokalaemia (n=212, 208)
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond

    		 Close Top of page
    End point title
    		 Number of Subjects with Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond
    End point description
    In this end point, liver function laboratory parameters, which included: normal bilirubin (bil.) and AST/ALT, Temple's Corollary (AST/ALT more than or equal to [>=]3*upper limit normal [ULN] and normal bilirubin), Gilbert's Syndrome (GS) or cholestasis (normal AST/ALT and bilirubin >=2*ULN) and Potential (Pot.) Hy's Law Cases (AST/ALT >=3*ULN and Bilirubin>=2*ULN) according to eDISH criteria, were reported. Safety randomised population included all subjects who were randomised and received at least one dose of dose of investigational product following the randomisation at Study Week 10. Here, "Number of Subjects Analysed" signifies subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Post randomisation up to end of study treatment (maximum of 22 weeks)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    211
    208
    Units: Subjects
        Normal Bilirubin and AST/ALT
    208
    207
        Temple's Corollary(AST/ALT>=3*ULN and Normal Bil.)
    2
    1
        GS or Cholestasis (Normal AST/ALT and Bil >=2*ULN)
    1
    0
        Pot Hy's Law Cases(AST/ALT>=3*ULN and Bil.>=2*ULN)
    0
    0
    No statistical analyses for this end point

    Secondary: Baseline, Absolute Week 32 Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Change From Baseline in SBP, DBP at Week 32 ([EOT]/[ET])

    		 Close Top of page
    End point title
    		 Baseline, Absolute Week 32 Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Change From Baseline in SBP, DBP at Week 32 ([EOT]/[ET])
    End point description
    SBP and DBP were measured in a supine position using an automated device preceded by at least 5 minutes of rest for the subject in a quiet setting without any distractions. Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomisation in TP2. Safety randomised population included all subjects who were randomised and received at least one dose of dose of investigational product following the randomisation at Study Week 10. Here, "Number of Subjects Analysed" signifies subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 32 (end of treatment [EOT]/early termination [ET])
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    212
    209
    Units: Millimetre of mercury
    arithmetic mean (standard deviation)
        SBP: Baseline
    125.7 ± 12.72
    125.9 ± 11.49
        SBP: Absolute value at Week 32 (EOT/ET)
    126.0 ± 11.20
    126.2 ± 12.69
        SBP: Change at Week 32 (EOT/ET)
    0.3 ± 11.49
    0.4 ± 11.28
        DBP: Baseline
    78.1 ± 8.31
    77.7 ± 7.60
        DBP: Absolute value at Week 32 (EOT/ET)
    78.6 ± 7.77
    77.5 ± 7.54
        DBP: Change at Week 32 (EOT/ET)
    0.5 ± 8.04
    -0.2 ± 8.32
    No statistical analyses for this end point

    Secondary: Baseline, Absolute Week 32 Values for Temperature and Change From Baseline in Temperature at Week 32 (EOT/ET)

    		 Close Top of page
    End point title
    		 Baseline, Absolute Week 32 Values for Temperature and Change From Baseline in Temperature at Week 32 (EOT/ET)
    End point description
    Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomisation in TP2. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10. Here, "Number of Subjects Analysed" signifies subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 32 (EOT/ET)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    212
    209
    Units: Degree Celsius
    arithmetic mean (standard deviation)
        Baseline
    36.5 ± 0.27
    36.5 ± 0.27
        Absolute at Week 32 (EOT/ET)
    36.4 ± 0.26
    36.4 ± 0.20
        Change at Week 32 (EOT/ET)
    -0.0 ± 0.28
    -0.0 ± 0.27
    No statistical analyses for this end point

    Secondary: Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET)

    		 Close Top of page
    End point title
    		 Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET)
    End point description
    Pulse rate was measured in a supine position using an automated device preceded by at least 5 minutes of rest for the subject in a quiet setting without any distractions. Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomisation in TP2. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10. Here, "Number of Subjects Analysed" signifies subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 32 (EOT/ET)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    212
    209
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Baseline
    73.6 ± 8.55
    73.2 ± 8.42
        Absolute value at Week 32 (EOT/ET)
    73.6 ± 7.94
    73.1 ± 7.98
        Change at Week 32 (EOT/ET)
    0.1 ± 8.55
    -0.2 ± 7.68
    No statistical analyses for this end point

    Secondary: Baseline, Absolute Week 32 Values for Respiratory Rate and Change From Baseline in Respiratory Rate at Week 32 (EOT/ET)

    		 Close Top of page
    End point title
    		 Baseline, Absolute Week 32 Values for Respiratory Rate and Change From Baseline in Respiratory Rate at Week 32 (EOT/ET)
    End point description
    Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomisation in TP2. Safety randomised population included all subjects who were randomised and received at least one dose of study treatment following the randomisation at Study Week 10. Here, "Number of Subjects Analysed" signifies subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 32 (EOT/ET)
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    212
    209
    Units: Breaths per minute
    arithmetic mean (standard deviation)
        Baseline
    16.6 ± 1.75
    16.6 ± 2.10
        Absolute at Week 32 (EOT/ET)
    16.5 ± 1.81
    16.6 ± 2.00
        Change at Week 32 (EOT/ET)
    -0.1 ± 1.36
    -0.0 ± 1.52
    No statistical analyses for this end point

    Secondary: Number of Subjects who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive

    		 Close Top of page
    End point title
    		 Number of Subjects who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive
    End point description
    Serum samples were analysed using a validated electrochemoluminescent (ECL) immunoassay for ADA assessment. Samples positive for ADA were further tested for neutralising activity using a validated cell based NAb assay. ADA positive was defined as ADA titer >=1.88 while NAb positive was defined as NAb titer >=0.70. Safety randomised population included all subjects who were randomised and received at least one dose of investigational product following the randomisation at Study Week 10. For ADA: n= all subjects assessed for ADA measurement at specific time points. For Nab: n= all subjects with ADA positive results assessed for Nab measurement at specific time points.
    End point type
    Secondary
    End point timeframe
    Week 10, 16, 22, 24, 26, 28, 30, 32
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Subjects
        Week 10: ADA positive (n=213, 214)
    55
    59
        Week 10: NAb positive (n=55, 59)
    22
    19
        Week 16: ADA positive (n=213, 214)
    88
    97
        Week 16: NAb positive (n=88, 97)
    22
    21
        Week 22: ADA positive (n=213, 214)
    96
    106
        Week 22: NAb positive (n=96, 106)
    24
    20
        Week 24: ADA positive (n=213, 214)
    102
    100
        Week 24: NAb positive (n=102, 100)
    19
    20
        Week 26: ADA positive (n=213, 214)
    101
    105
        Week 26: NAb positive (n=101, 105)
    21
    15
        Week 28: ADA positive (n=213, 214)
    102
    105
        Week 28: NAb positive (n=102, 105)
    18
    16
        Week 30: ADA positive (n=213, 214)
    103
    109
        Week 30: NAb positive (n=103, 109)
    17
    19
        Week 32: ADA positive (n=213, 214)
    100
    104
        Week 32: NAb positive (n=100, 104)
    18
    18
    No statistical analyses for this end point

    Secondary: Mean ADA Titers

    		 Close Top of page
    End point title
    		 Mean ADA Titers
    End point description
    Serum samples were analysed using a validated ECL immunoassay for ADA assessment. Endpoint titer was defined as log10 of the reciprocal of the ADA serum dilution at which the sample response was equal to the cut-point of the assay. Safety randomised population included all subjects who were randomised and received at least one dose of investigational product following the randomisation at Study Week 10. Here, n signifies subjects evaluable with ADA non-missing values at specific time points.
    End point type
    Secondary
    End point timeframe
    Week 10, 16, 22, 24, 26, 28, 30, 32
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Endpoint titer
    arithmetic mean (standard deviation)
        Week 10 (n=211, 214)
    0.830 ± 1.46534
    0.880 ± 1.51789
        Week 16 (n=210, 209)
    1.385 ± 1.71192
    1.546 ± 1.75299
        Week 22 (n=208, 202)
    1.570 ± 1.77364
    1.784 ± 1.79136
        Week 24 (n=207, 199)
    1.674 ± 1.78148
    1.709 ± 1.78301
        Week 26 (n=204, 198)
    1.671 ± 1.77780
    1.806 ± 1.78134
        Week 28 (n=205, 197)
    1.670 ± 1.77759
    1.788 ± 1.77325
        Week 30 (n=206, 198)
    1.658 ± 1.75135
    1.854 ± 1.78187
        Week 32 (n=199, 193)
    1.677 ± 1.76060
    1.846 ± 1.81474
    No statistical analyses for this end point

    Secondary: Mean NAb Titers

    		 Close Top of page
    End point title
    		 Mean NAb Titers
    End point description
    Serum samples were analysed using a validated ECL immunoassay for ADA assessment. Endpoint titer was defined as log10 of the reciprocal of the NAb serum dilution at which the sample response was equal to the cut-point of the assay. Safety randomised population included all subjects who were randomised and received at least one dose of investigational product following the randomisation at Study Week 10. Here, n signifies subjects evaluable with NAb non-missing values at specific time points.
    End point type
    Secondary
    End point timeframe
    Week 10, 16, 22, 24, 26, 28, 30, 32
    End point values
    		 Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
    Number of subjects analysed
    213
    214
    Units: Endpoint titer
    arithmetic mean (standard deviation)
        Week 10 (n=55, 58)
    0.712 ± 1.02024
    0.718 ± 1.14660
        Week 16 (n=88, 97)
    0.467 ± 0.90051
    0.443 ± 0.92450
        Week 22 (n=96, 106)
    0.488 ± 0.91641
    0.405 ± 0.89940
        Week 24 (n=102, 100)
    0.396 ± 0.87759
    0.409 ± 0.90030
        Week 26 (n=101, 105)
    0.420 ± 0.90500
    0.328 ± 0.84792
        Week 28 (n=102, 105)
    0.360 ± 0.83177
    0.353 ± 0.88464
        Week 30 (n=103, 109)
    0.359 ± 0.87754
    0.377 ± 0.91439
        Week 32 (n=100, 104)
    0.341 ± 0.81482
    0.362 ± 0.88055
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    TP1: Day 1 up to maximum of 10 Weeks TP2 and beyond: Post randomisation up to maximum of 4 weeks after last dose (maximum of 26 weeks)
    Adverse event reporting additional description
    Same event may appear as both AE and SAE but are distinct events. Event may be categorised serious in 1 subject and non-serious in another,or 1 subject may have experienced both serious and non-serious event during study. For TP1 (Humira arm), Safety-TP1 population. For TP2 and beyond (switching and non-switching arm), Safety-randomised population.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Humira (Adalimumab)
    Reporting group description
    		 All subjects received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.

    Reporting group title
    Non-switching Arm: Humira (Adalimumab)
    Reporting group description
    		 Subjects after completing TP1, were randomised to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks. Subjects were followed for 4 weeks post last dose.

    Reporting group title
    Switching Arm: Humira and PF-06410293 (Adalimumab)
    Reporting group description
    		 Subjects after completing TP1, were randomised to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during TP2. TP2 was followed by TP3. In TP3 subjects received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by TP4. In TP4 subjects received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Subjects were followed for 4 weeks post last dose.

    Serious adverse events
    		 Humira (Adalimumab) Non-switching Arm: Humira (Adalimumab) Switching Arm: Humira and PF-06410293 (Adalimumab)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 445 (2.92%)
    8 / 214 (3.74%)
    3 / 213 (1.41%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian cancer metastatic
         subjects affected / exposed
    1 / 445 (0.22%)
    0 / 214 (0.00%)
    0 / 213 (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
    Injury, poisoning and procedural complications
    Subdural haemorrhage
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    0 / 213 (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
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    0 / 213 (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
    Blood and lymphatic system disorders
    Blood loss anaemia
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    0 / 213 (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
    Eye disorders
    Keratitis
         subjects affected / exposed
    0 / 445 (0.00%)
    0 / 214 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 445 (0.22%)
    0 / 214 (0.00%)
    0 / 213 (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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 445 (0.22%)
    0 / 214 (0.00%)
    0 / 213 (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
    Cholecystitis acute
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    0 / 213 (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
    Back pain
         subjects affected / exposed
    1 / 445 (0.22%)
    0 / 214 (0.00%)
    0 / 213 (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
    COVID-19
         subjects affected / exposed
    5 / 445 (1.12%)
    1 / 214 (0.47%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 445 (0.22%)
    2 / 214 (0.93%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 445 (0.00%)
    0 / 214 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 445 (0.22%)
    1 / 214 (0.47%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lyme disease
         subjects affected / exposed
    2 / 445 (0.45%)
    0 / 214 (0.00%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 445 (0.22%)
    0 / 214 (0.00%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Humira (Adalimumab) Non-switching Arm: Humira (Adalimumab) Switching Arm: Humira and PF-06410293 (Adalimumab)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 445 (6.29%)
    38 / 214 (17.76%)
    46 / 213 (21.60%)
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    9 / 445 (2.02%)
    14 / 214 (6.54%)
    18 / 213 (8.45%)
         occurrences all number
    9
    14
    19
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    3 / 213 (1.41%)
         occurrences all number
    0
    1
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    3 / 213 (1.41%)
         occurrences all number
    0
    1
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 445 (0.00%)
    5 / 214 (2.34%)
    2 / 213 (0.94%)
         occurrences all number
    0
    5
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 445 (0.00%)
    4 / 214 (1.87%)
    4 / 213 (1.88%)
         occurrences all number
    0
    4
    4
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    13 / 445 (2.92%)
    4 / 214 (1.87%)
    6 / 213 (2.82%)
         occurrences all number
    17
    24
    9
    Swelling
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    3 / 213 (1.41%)
         occurrences all number
    0
    4
    3
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 445 (0.00%)
    0 / 214 (0.00%)
    3 / 213 (1.41%)
         occurrences all number
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    3 / 213 (1.41%)
         occurrences all number
    0
    1
    3
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    10 / 445 (2.25%)
    4 / 214 (1.87%)
    6 / 213 (2.82%)
         occurrences all number
    17
    24
    9
    Pruritus
         subjects affected / exposed
    7 / 445 (1.57%)
    0 / 214 (0.00%)
    0 / 213 (0.00%)
         occurrences all number
    9
    0
    0
    Rash
         subjects affected / exposed
    0 / 445 (0.00%)
    0 / 214 (0.00%)
    3 / 213 (1.41%)
         occurrences all number
    0
    0
    3
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 445 (0.00%)
    1 / 214 (0.47%)
    3 / 213 (1.41%)
         occurrences all number
    0
    1
    3
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    5 / 445 (1.12%)
    3 / 214 (1.40%)
    4 / 213 (1.88%)
         occurrences all number
    5
    3
    5
    COVID-19
         subjects affected / exposed
    0 / 445 (0.00%)
    9 / 214 (4.21%)
    16 / 213 (7.51%)
         occurrences all number
    0
    9
    18
    Nasopharyngitis
         subjects affected / exposed
    0 / 445 (0.00%)
    7 / 214 (3.27%)
    0 / 213 (0.00%)
         occurrences all number
    0
    7
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 445 (0.00%)
    3 / 214 (1.40%)
    3 / 213 (1.41%)
         occurrences all number
    0
    3
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2020
    Added new Exclusion Criterion that unstable dose of oral and intramuscular (IM) corticosteroid is prohibited. Add clarification to Exclusion Criterion (3) that active significant infection e.g., SARS-CoV2 (COVID-19) infection and any active infection considered to be clinically significant by the investigator should be excluded.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Mar 2020
    Enrollment, randomization, and screening for the study were paused at all sites.
    06 May 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In subject disposition discontinuation due to AEs,were captured under different reasons (e.g. other, physician decision etc.) as study case report form (CRF) did not include AE as option for sites to record if discontinuation was due to AE.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 09 01:50:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA