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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis

    Summary
    EudraCT number
    		 2017-002988-18
    Trial protocol
    		 DE   AT   DK   HU   FR   SE   EE   ES   NL   PT   SI   BE   HR   GB   NO   FI   IT  
    Global end of trial date
    24 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Dec 2021
    First version publication date
    05 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC15068
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03600805
    WHO universal trial number (UTN)
    		 U1111-1200-2184
    Sponsors
    Sponsor organisation name
    Sanofi-aventis Recherche & Développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly Mazarin Cedex, France, 91385
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    03 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of sarilumab in subjects with giant cell arteritis (GCA) as assessed by the proportion of subjects with sustained remission at Week 52 for sarilumab compared to placebo, in combination with a 26-week corticosteroid (CS) tapering course.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2018
    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
    Belgium: 2
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Switzerland: 3
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Argentina: 2
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Croatia: 1
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Slovenia: 1
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    Australia: 2
    Worldwide total number of subjects
    83
    EEA total number of subjects
    56
    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)
    18
    From 65 to 84 years
    61
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 48 active centers in 19 countries. A total of 125 subjects were screened between 20 November 2018 and 19 March 2020, of whom 42 subjects were screen failures. Screen failures were mainly due to not meeting inclusion criteria. A total of 83 subjects were enrolled and randomised in the study.

    Pre-assignment
    Screening details
    		 Subjects were randomised to 4 treatments arms in 2:1:1:2 ratio by interactive response technology stratified by starting dose of prednisone at Baseline (less than [<] 30 milligrams per day (mg/day) or greater than or equal to [>=] 30 mg/day).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo+52 week taper
    Arm description
    		 Subjects received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone or Prednisone matched to placebo tapering oral doses daily for 26 weeks according to the protocol-defined schedule.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to sarilumab, single SC injection q2w for 52 weeks.

    Arm title
    		 Placebo+26 week taper
    Arm description
    		 Subjects received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to sarilumab, single SC injection q2w for 52 weeks.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone or Prednisone matched to placebo tapering oral doses daily for 26 weeks according to the protocol-defined schedule.

    Arm title
    		 Sarilumab 150mg q2w+26 week taper
    Arm description
    		 Subjects received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone or Prednisone matched to placebo tapering oral doses daily for 26 weeks according to the protocol-defined schedule.

    Investigational medicinal product name
    Sarilumab (150 mg)
    Investigational medicinal product code
    SAR153191
    Other name
    Kevzara®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Sarilumab 150 mg, single SC injection q2w for 52 weeks.

    Arm title
    		 Sarilumab 200mg q2w+26 week taper
    Arm description
    		 Subjects received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone or Prednisone matched to placebo tapering oral doses daily for 26 weeks according to the protocol-defined schedule.

    Investigational medicinal product name
    Sarilumab (200 mg)
    Investigational medicinal product code
    SAR153191
    Other name
    Kevzara®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Sarilumab 200 mg, single SC injection q2w for 52 weeks.

    Number of subjects in period 1
    		Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Started
    28
    14
    14
    27
    Week 52 Analysis set Population
    10
    6
    7
    13
    Completed
    9
    6
    6
    8
    Not completed
    19
    8
    8
    19
         Consent withdrawn by subject
    1
    -
    -
    1
         Other unspecified
    14
    6
    7
    11
         Adverse event, non-fatal
    2
    1
    1
    7
         Lack of efficacy
    2
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo+52 week taper
    Reporting group description
    		 Subjects received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.

    Reporting group title
    Placebo+26 week taper
    Reporting group description
    		 Subjects received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Reporting group title
    Sarilumab 150mg q2w+26 week taper
    Reporting group description
    		 Subjects received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Reporting group title
    Sarilumab 200mg q2w+26 week taper
    Reporting group description
    		 Subjects received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Reporting group values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper Total
    Number of subjects
    		 28 14 14 27
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.4 ( 7.7 ) 69.5 ( 5.4 ) 67.1 ( 7.9 ) 73.4 ( 8.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 9 13 23 67
        Male
    		 6 5 1 4 16
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 1 0 1
        White
    		 23 13 11 25 72
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 5 1 2 2 10

    End points

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    End points reporting groups
    Reporting group title
    Placebo+52 week taper
    Reporting group description
    		 Subjects received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.

    Reporting group title
    Placebo+26 week taper
    Reporting group description
    		 Subjects received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Reporting group title
    Sarilumab 150mg q2w+26 week taper
    Reporting group description
    		 Subjects received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Reporting group title
    Sarilumab 200mg q2w+26 week taper
    Reporting group description
    		 Subjects received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Primary: Percentage of Subjects who Achieved Sustained Disease Remission at Week 52

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    End point title
    		 Percentage of Subjects who Achieved Sustained Disease Remission at Week 52 [1]
    End point description
    Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalisation of C-reactive protein (CRP) (<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid [CS] dose due to GCA or elevation of erythrocyte sedimentation rate [ESR] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalisation of CRP (to <10 mg/L, with absence of successive elevations to >=10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52. Analysis was performed on Week 52 Analysis set population that included all randomised subjects who had opportunity to complete the 52-week treatment period (randomised prior to October 16th, 2019).
    End point type
    Primary
    End point timeframe
    At Week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    10
    6
    7
    13
    Units: percentage of subjects
        number (not applicable)
    30.0
    0
    42.9
    46.2
    No statistical analyses for this end point

    Primary: Percentage of Subjects who Achieved Sustained Disease Remission at Week 24

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    End point title
    		 Percentage of Subjects who Achieved Sustained Disease Remission at Week 24 [2]
    End point description
    Disease remission was defined as resolution of signs and symptoms of GCA, and normalisation of CRP <10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalisation of CRP (to <10 mg/L, with an absence of successive elevations to >=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24. Analysis was performed on intent-to-treat (ITT) population that included subjects who were allocated to a randomised treatment regardless of whether the treatment kit was used, and were analysed according to the treatment group allocated by randomisation.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: percentage of subjects
        number (not applicable)
    39.3
    7.1
    42.9
    48.1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Achievement of Disease Remission up to Week 12: Week 52 Analysis set

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    End point title
    		 Number of Subjects With Achievement of Disease Remission up to Week 12: Week 52 Analysis set
    End point description
    Disease remission was defined as resolution of signs and symptoms of GCA, and normalisation of CRP (< 10 mg/L). The status of normalisation of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalisation of CRP. Subjects who took rescue corticosteroid (CS) due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. Analysis was performed on Week 52 Analysis set.
    End point type
    Secondary
    End point timeframe
    up to Week 12
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    10
    6
    7
    13
    Units: subjects
    7
    3
    4
    7
    No statistical analyses for this end point

    Secondary: Number of Subjects With Achievement of Disease Remission up to Week 12: ITT Population

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    End point title
    		 Number of Subjects With Achievement of Disease Remission up to Week 12: ITT Population
    End point description
    Disease remission was defined as resolution of signs and symptoms of GCA, and normalisation of CRP (< 10 mg/L). The status of normalisation of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalisation of CRP. Subjects who took rescue CS due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    up to Week 12
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: subjects
    16
    6
    9
    15
    No statistical analyses for this end point

    Secondary: Number of Subjects With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis set

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    End point title
    		 Number of Subjects With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis set
    End point description
    Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of subjects with absence of disease flare from Week 12 through Week 52 were reported. Analysis was performed on Week 52 Analysis set.
    End point type
    Secondary
    End point timeframe
    From Week 12 through Week 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    10
    6
    7
    13
    Units: subjects
    7
    3
    4
    7
    No statistical analyses for this end point

    Secondary: Number of Subjects With Absence of Disease Flare From Week 12 Through Week 24: ITT Population

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    End point title
    		 Number of Subjects With Absence of Disease Flare From Week 12 Through Week 24: ITT Population
    End point description
    Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of subjects with absence of disease flare from Week 12 through Week 24 were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From Week 12 through Week 24
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: subjects
    21
    7
    10
    15
    No statistical analyses for this end point

    Secondary: Number of Subjects With Normalisation of C-Reactive Protein (CRP) From Week 12 Through Week 52: Week 52 Analysis set

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    End point title
    		 Number of Subjects With Normalisation of C-Reactive Protein (CRP) From Week 12 Through Week 52: Week 52 Analysis set
    End point description
    Normalisation of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorised as no normalisation of CRP. Analysis was performed on Week 52 Analysis set.
    End point type
    Secondary
    End point timeframe
    From Week 12 through Week 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    10
    6
    7
    13
    Units: subjects
    6
    3
    5
    8
    No statistical analyses for this end point

    Secondary: Number of Subjects With Normalisation of C-Reactive Protein From Week 12 Through Week 24: ITT Population

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    End point title
    		 Number of Subjects With Normalisation of C-Reactive Protein From Week 12 Through Week 24: ITT Population
    End point description
    Normalisation of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorised as no normalisation of CRP. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From Week 12 through Week 24
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: subjects
    20
    4
    11
    17
    No statistical analyses for this end point

    Secondary: Number of Subjects With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis set

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    End point title
    		 Number of Subjects With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis set
    End point description
    Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as subjects who did not take rescue therapy from Week 12 through Week 52 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to GCA. Analysis was performed on Week 52 Analysis set.
    End point type
    Secondary
    End point timeframe
    From Week 12 through Week 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    10
    6
    7
    13
    Units: subjects
    6
    2
    3
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population

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    End point title
    		 Number of Subjects With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population
    End point description
    Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as subjects who did not take rescue therapy from Week 12 through Week 24 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage AE not related to GCA. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From Week 12 through Week 24
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: subjects
    18
    5
    7
    13
    No statistical analyses for this end point

    Secondary: Total Cumulative Corticosteroid (Including Prednisone) Dose

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    End point title
    		 Total Cumulative Corticosteroid (Including Prednisone) Dose
    End point description
    Cumulative dose of CS used for GCA disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period employed to manage AE not related to GCA). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: milligrams
        arithmetic mean (standard deviation)
    2577.3 ( 1018.3 )
    2270.7 ( 1418.0 )
    2177.1 ( 1326.7 )
    1643.1 ( 967.3 )
    No statistical analyses for this end point

    Secondary: Time to First Giant Cell Arteritis Disease Flare

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    End point title
    		 Time to First Giant Cell Arteritis Disease Flare
    End point description
    Time to first GCA flare was defined as the duration (in days) from randomisation to first GCA flare after clinical remission (defined as resolution of signs and symptoms and normalisation of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to GCA or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Kaplan-Meier method was used for the analysis. Subjects who never achieved remission were censored at randomisation day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52. Analysis was performed on ITT population. Here, 99999 is used as a space filler which represents that the specified field data were not estimable due to very low number of subjects with the events.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: days
        median (confidence interval 95%)
    99999 (141.000 to 99999)
    170.00 (85.000 to 99999)
    99999 (58.000 to 99999)
    99999 (77.000 to 99999)
    No statistical analyses for this end point

    Secondary: Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population

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    End point title
    		 Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population
    End point description
    GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 24 are reported in this endpoint. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies least toxicity and maximum score implies the most toxicity. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: units on a scale
    arithmetic mean (standard deviation)
        Cumulative worsening score
    29.2 ( 30.8 )
    30.7 ( 33.2 )
    55.1 ( 43.1 )
    31.0 ( 42.9 )
        Aggregate improvement score
    -21.6 ( 54.8 )
    -13.4 ( 44.3 )
    14.2 ( 55.0 )
    -3.3 ( 43.4 )
    No statistical analyses for this end point

    Secondary: Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52

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    End point title
    		 Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52
    End point description
    GTI assessed GC related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was sum of 9 domain-specific scores at each visit and Cumulative GTI score was sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this endpoint. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, minimum score implies the least toxicity and maximum score implies the most toxicity. Analysed on Week 52 analysis set. Here, 'number of subjects analysed'=subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    10
    6
    6
    11
    Units: units on a scale
    arithmetic mean (standard deviation)
        Cumulative worsening score
    73.0 ( 50.3 )
    84.7 ( 33.4 )
    77.2 ( 41.7 )
    52.8 ( 39.0 )
        Aggregate improvement score
    -19.5 ( 65.0 )
    31.2 ( 54.7 )
    23.7 ( 31.9 )
    -0.5 ( 51.5 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a subject who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalisation, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP +60 days). Analysis was performed on safety population that included subjects who had received at least one dose or part of a dose of investigational medicinal product (IMP) and were analysed according to the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From first dose (i.e., Day 1) up to 60 days after last dose (i.e., up to Week 60)
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: subjects
        Any TEAE
    24
    14
    13
    22
        Any treatment emergent SAE
    2
    3
    2
    7
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab

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    End point title
    		 Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab [3]
    End point description
    Ctrough was pre dose concentration of drug. Data for this endpoint was not planned to be collected and analysed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol. Analysis was performed on PK analysis population which included subjects who had received at least one dose or part of a dose of IMP, were analysed according to the treatment actually received and had at least 1 post-dose non-missing serum sarilumab concentration value. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint is reported for all applicable arms in the study.
    End point values
    		 Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    14
    26
    Units: nanograms per millilitre
    arithmetic mean (standard deviation)
        Baseline (n = 14, 26)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 2 (n = 14, 25)
    2099.29 ( 3114.92 )
    5400.82 ( 4124.63 )
        Week 4 (n = 13, 25)
    4644.71 ( 5994.17 )
    11640.98 ( 8574.00 )
        Week 12 (n = 13, 20)
    8371.33 ( 7608.42 )
    27586.00 ( 17496.07 )
        Week 16 (n = 12, 17)
    8111.08 ( 5962.56 )
    28911.88 ( 20821.06 )
        Week 24 (n = 12, 19)
    12926.67 ( 9509.92 )
    35451.74 ( 23953.29 )
        Week 52 (n = 6, 9)
    19780.00 ( 21829.95 )
    46766.67 ( 21172.15 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24

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    End point title
    		 Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24 [4]
    End point description
    Serum concentrations of functional sarilumab were analysed using validated enzyme linked immunosorbent assay. Analysis was performed on PK analysis population. Here, ‘number of subjects analysed’ = subjects for this endpoint. Data for this endpoint was not planned to be collected and analysed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol.
    End point type
    Secondary
    End point timeframe
    post-dose at Week 24
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint is reported for all applicable arms in the study.
    End point values
    		 Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    11
    13
    Units: nanograms per millilitre
        arithmetic mean (standard deviation)
    25255.45 ( 17510.38 )
    44551.54 ( 28298.62 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment-emergent Antidrug Antibodies (ADA) Response

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    End point title
    		 Percentage of Subjects With Treatment-emergent Antidrug Antibodies (ADA) Response
    End point description
    ADA response categories: 1) Treatment-boosted ADA positive subject: subject with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive subject: subject with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Titer values were categorised as low (titer <1,000); moderate (1,000<= titer <=10,000) and high (titer >10,000). Analysis was performed on ADA population that included subjects who had received at least one dose or part of a dose of IMP, were analysed according to the treatment actually received and had at least 1 non-missing ADA result in the ADA assay following the first dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) up to last dose date of study drug + 60 days (i.e., up to Week 60)
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    26
    13
    14
    24
    Units: percentage of subjects
    number (not applicable)
        Treatment-boosted ADA positive subjects
    0
    0
    0
    0
        Treatment-emergent ADA positive subjects
    3.8
    0
    7.1
    0
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

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    End point title
    		 Pharmacodynamics: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
    End point description
    ESR is a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimetres per hour. Analysis was performed on ITT population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    27
    11
    14
    24
    Units: millimeters per hour
    arithmetic mean (standard deviation)
        Week 2 (n = 27, 11, 14, 24)
    -1.1 ( 17.9 )
    0.7 ( 11.4 )
    -10.4 ( 16.4 )
    -8.8 ( 12.4 )
        Week 4 (n = 25, 10, 13, 25)
    -4.2 ( 21.4 )
    5.2 ( 19.7 )
    -13.3 ( 22.6 )
    -9.4 ( 15.2 )
        Week 8 (n = 24, 13, 12, 24)
    -2.0 ( 22.7 )
    10.2 ( 12.6 )
    -11.9 ( 18.9 )
    -8.7 ( 16.1 )
        Week 12 (n = 21, 13, 12, 23)
    -1.5 ( 24.9 )
    9.8 ( 13.3 )
    -14.7 ( 19.2 )
    -11.0 ( 14.1 )
        Week 16 (n = 22, 12, 13, 19)
    -4.1 ( 22.7 )
    9.8 ( 16.5 )
    -13.5 ( 18.1 )
    -10.4 ( 12.7 )
        Week 20 (n = 21, 11, 14, 20)
    -6.6 ( 23.7 )
    8.8 ( 14.6 )
    -18.2 ( 23.5 )
    -10.9 ( 12.2 )
        Week 24 (n = 21, 10, 14, 22)
    -4.2 ( 22.0 )
    13.9 ( 16.1 )
    -16.4 ( 25.6 )
    -9.3 ( 11.5 )
        Week 32 (n = 22, 10, 9, 17)
    -7.0 ( 21.3 )
    6.6 ( 16.2 )
    -9.4 ( 18.0 )
    -7.9 ( 10.6 )
        Week 40 (n = 19, 8, 8, 14)
    -1.5 ( 22.3 )
    4.0 ( 18.1 )
    -10.1 ( 25.2 )
    -7.9 ( 8.6 )
        Week 52 (n = 13, 7, 6, 10)
    -1.0 ( 27.0 )
    -1.4 ( 12.4 )
    -15.2 ( 19.0 )
    -7.0 ( 12.0 )
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: Change from Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

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    End point title
    		 Pharmacodynamics: Change from Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
    End point description
    CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body. Analysis was performed on ITT population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    27
    11
    14
    26
    Units: milligrams per Litre
    arithmetic mean (standard deviation)
        Week 2 (n = 27, 11, 14, 26)
    0.8 ( 20.7 )
    -1.0 ( 21.2 )
    -3.5 ( 11.2 )
    -2.0 ( 7.6 )
        Week 4 (n = 25, 11, 13, 25)
    -3.6 ( 19.3 )
    -2.2 ( 21.8 )
    -2.6 ( 18.7 )
    -1.9 ( 8.3 )
        Week 8 (n = 24, 13, 12, 24)
    -3.8 ( 19.1 )
    -1.9 ( 16.6 )
    -3.5 ( 11.7 )
    -1.4 ( 5.2 )
        Week 12 (n = 21, 13, 13, 23)
    -4.4 ( 22.0 )
    2.9 ( 18.9 )
    -3.3 ( 17.9 )
    -1.0 ( 8.0 )
        Week 16 (n = 22, 12, 13, 18)
    -4.5 ( 20.7 )
    3.6 ( 23.3 )
    -5.0 ( 14.1 )
    -1.7 ( 2.9 )
        Week 20 (n = 21, 11, 14, 20)
    -4.5 ( 21.1 )
    1.4 ( 16.4 )
    -7.2 ( 15.6 )
    -1.9 ( 3.5 )
        Week 24 (n = 21, 10, 13, 22)
    -4.1 ( 19.5 )
    0.9 ( 26.9 )
    -5.7 ( 19.8 )
    -0.8 ( 4.1 )
        Week 32 (n = 22, 10, 9, 17)
    -5.0 ( 19.2 )
    0.3 ( 29.1 )
    -6.9 ( 16.0 )
    -0.1 ( 5.9 )
        Week 40 (n = 19, 7, 8, 14)
    -3.6 ( 21.1 )
    -8.2 ( 24.8 )
    -2.0 ( 10.3 )
    -2.0 ( 3.4 )
        Week 52 (n = 12, 7, 6, 10)
    -1.1 ( 31.5 )
    -8.0 ( 27.2 )
    -4.8 ( 4.2 )
    -1.9 ( 4.6 )
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: Change from Baseline in Interleukin-6 (IL-6) Level at Weeks 2, 12, 24, and 52

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    End point title
    		 Pharmacodynamics: Change from Baseline in Interleukin-6 (IL-6) Level at Weeks 2, 12, 24, and 52
    End point description
    Interleukin-6 is a protein produced in the body. Levels of IL-6 increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. Analysis was performed on safety population. Here, 'n' = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 12, 24, and 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: nanograms per Litre
    arithmetic mean (standard deviation)
        Week 2 (n = 23, 8, 13, 22)
    2.90 ( 17.46 )
    3.47 ( 10.30 )
    31.74 ( 31.13 )
    117.33 ( 245.28 )
        Week 12 (n = 18, 7, 11, 17)
    -0.88 ( 12.60 )
    5.56 ( 8.08 )
    52.38 ( 47.46 )
    81.82 ( 50.85 )
        Week 24 (n = 20, 4, 11, 15)
    -1.03 ( 7.15 )
    5.57 ( 19.81 )
    53.60 ( 53.71 )
    69.20 ( 46.89 )
        Week 52 (n = 7, 3, 3, 6)
    0.43 ( 5.58 )
    2.82 ( 1.90 )
    42.14 ( 8.52 )
    33.28 ( 32.37 )
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52

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    End point title
    		 Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
    End point description
    Interleukin-6 is a protein produced in the body. Levels of IL-6 increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. Analysis was performed on safety population. Here, 'n' = subjects with available data for each specified category, '9999’ = a space filler, which signifies that no subjects were available for assessments at the specified time points in the respective arm and '999' = a space filler, which signifies that SD was not estimable at the specified time point (i.e., sIL-6R: Week 12) because only 1 subject was available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 12, 24, and 52
    End point values
    		 Placebo+52 week taper Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Sarilumab 200mg q2w+26 week taper
    Number of subjects analysed
    28
    14
    14
    27
    Units: nanograms per millilitre
    arithmetic mean (standard deviation)
        Week 2 (n = 0, 0 13, 26)
    9999 ( 9999 )
    9999 ( 9999 )
    212.19 ( 51.99 )
    224.87 ( 107.43 )
        Week 12 (n = 1, 0, 12, 21)
    17.67 ( 999 )
    9999 ( 9999 )
    336.30 ( 107.49 )
    427.40 ( 124.97 )
        Week 24 (n = 3, 0, 11, 18)
    -12.72 ( 3.97 )
    9999 ( 9999 )
    311.88 ( 184.32 )
    456.09 ( 118.07 )
        Week 52 (n = 8, 2, 4, 7)
    -131.47 ( 356.65 )
    -9.69 ( 11.14 )
    377.23 ( 84.99 )
    471.16 ( 182.72 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose (i.e., Day 1) of study drug to last dose date of study drug + 60 days (i.e., up to Week 60)
    Adverse event reporting additional description
    Reported AEs and deaths were treatment emergent AEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo+26 week taper
    Reporting group description
    		 Subjects received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Reporting group title
    Sarilumab 150mg q2w+26 week taper
    Reporting group description
    		 Subjects received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Reporting group title
    Placebo+52 week taper
    Reporting group description
    		 Subjects received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.

    Reporting group title
    Sarilumab 200mg q2w+26 week taper
    Reporting group description
    		 Subjects received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Subjects received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.

    Serious adverse events
    		 Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Placebo+52 week taper Sarilumab 200mg q2w+26 week taper
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 14 (21.43%)
    2 / 14 (14.29%)
    2 / 28 (7.14%)
    7 / 27 (25.93%)
         number of deaths (all causes)
    1
    0
    0
    2
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femur Fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic Dissection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep Vein Thrombosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral Amyloid Angiopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blindness Unilateral
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal Artery Occlusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis Ulcerative
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus Hernia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Covid-19
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cellulitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic Shock
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo+26 week taper Sarilumab 150mg q2w+26 week taper Placebo+52 week taper Sarilumab 200mg q2w+26 week taper
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 14 (92.86%)
    13 / 14 (92.86%)
    22 / 28 (78.57%)
    20 / 27 (74.07%)
    Vascular disorders
    Hypertension
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    1
    1
    0
    3
    Hypertensive Emergency
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Peripheral Arterial Occlusive Disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Phlebitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Injection Site Erythema
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    9
    0
    0
    Injection Site Pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection Site Pruritus
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    1
    Injection Site Rash
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    1
    Injection Site Reaction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    4 / 14 (28.57%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    8
    0
    1
    Injection Site Swelling
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Malaise
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Oedema Peripheral
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    0
    2
    Vessel Puncture Site Phlebitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Uterine Polyp
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic Cough
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cough
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    3 / 28 (10.71%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    3
    2
    Dyspnoea
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dyspnoea Exertional
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Emphysema
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oropharyngeal Pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 14 (14.29%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Sleep Apnoea Syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Depressed Mood
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Depression
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    5 / 28 (17.86%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    5
    1
    Insomnia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 14 (14.29%)
    3 / 28 (10.71%)
    2 / 27 (7.41%)
         occurrences all number
    2
    2
    3
    2
    Mania
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    5 / 14 (35.71%)
    1 / 14 (7.14%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    5
    1
    2
    2
    Investigations
    Creatinine Renal Clearance Decreased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    International Normalised Ratio Increased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Weight Increased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    2
    Injury, poisoning and procedural complications
    Arthropod Bite
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Contusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    2
    Fall
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    4 / 27 (14.81%)
         occurrences all number
    2
    0
    0
    4
    Post-Traumatic Pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    2
    Skin Laceration
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    1
    0
    2
    Spinal Compression Fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Stress Fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vaccination Complication
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Atrial Fibrillation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    2
    0
    0
    1
    Palpitations
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Burning Sensation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cognitive Disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 14 (7.14%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    1
    1
    Decreased Vibratory Sense
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dizziness
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Headache
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 14 (7.14%)
    5 / 28 (17.86%)
    4 / 27 (14.81%)
         occurrences all number
    7
    1
    6
    5
    Memory Impairment
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Syncope
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Increased Tendency To Bruise
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    3 / 14 (21.43%)
    3 / 14 (21.43%)
    5 / 28 (17.86%)
    3 / 27 (11.11%)
         occurrences all number
    3
    3
    5
    4
    Neutropenia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 14 (14.29%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ear and labyrinth disorders
    Tinnitus
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vertigo
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    Eye disorders
    Amaurosis Fugax
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cataract
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 14 (14.29%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
         occurrences all number
    0
    4
    1
    1
    Cataract Subcapsular
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conjunctivitis Allergic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dry Eye
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye Irritation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Keratitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Refraction Disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vision Blurred
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vitreous Floaters
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal Pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 28 (3.57%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    3
    Abdominal Pain Upper
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dental Caries
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    Diarrhoea
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 14 (21.43%)
    2 / 28 (7.14%)
    3 / 27 (11.11%)
         occurrences all number
    2
    3
    4
    4
    Dysphagia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Inguinal Hernia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Large Intestine Polyp
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vomiting
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    3 / 28 (10.71%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    3
    1
    Skin and subcutaneous tissue disorders
    Alopecia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 14 (14.29%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Ecchymosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eczema
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    2
    Erythema
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    2
    1
    Hirsutism
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 14 (7.14%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Hyperhidrosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Hypertrichosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    2
    Miliaria
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Night Sweats
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Photosensitivity Reaction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin Atrophy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin Discharge
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin Exfoliation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin Fragility
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin Striae
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 14 (14.29%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    2
    0
    1
    Skin Ulcer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urticaria
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    Endocrine disorders
    Adrenal Insufficiency
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Goitre
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    4 / 14 (28.57%)
    2 / 28 (7.14%)
    2 / 27 (7.41%)
         occurrences all number
    0
    4
    2
    3
    Arthropathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Back Pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    1
    0
    1
    Bursitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 14 (14.29%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
         occurrences all number
    1
    3
    1
    1
    Chondrocalcinosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Intervertebral Disc Protrusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Muscle Spasms
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    1
    1
    Musculoskeletal Chest Pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    1
    Myopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    Osteoarthritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Osteopenia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain In Extremity
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pain In Jaw
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    Rotator Cuff Syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Spinal Osteoarthritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Cellulitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cystitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    3
    1
    Gastroenteritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Herpes Simplex
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    4
    1
    Herpes Zoster
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Influenza
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Localised Infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    Oral Candidiasis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oral Herpes
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 28 (3.57%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    2
    Respiratory Tract Infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Sinusitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tooth Infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary Tract Infection Bacterial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    1
    Viral Upper Respiratory Tract Infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    Glucose Tolerance Impaired
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypercholesterolaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hyperlipidaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    1
    Hypokalaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Steroid Diabetes
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2018
    The following amendment changes were done: - The assumed treatment effects used for the power calculations were added for clarity. - Sub-section of benefit and risk assessment was created to address a specific request from the European Regulatory Authorities and to align it with the current protocol template of the Sponsor. - Additional detail was added to method of assigning subjects to treatment group section to provide clarity on the randomisation procedure, particularly pertaining to the blocked randomisation and stratification process employed in the study. - Based on the results from the GiACTA study, the non-inferiority test was deemed as unnecessary and thus removed from the protocol. - Details on the hierarchical testing sequence for the secondary endpoints were added for clarification to address a specific request from the European Regulatory Authorities.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    19 Mar 2020
    Study was prematurely discontinued due to protracted enrolment exacerbated by Covid-19 pandemic situation, screening/recruitment were suspended 19-Mar-2020, discontinued 21-Jul-2020.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study was prematurely discontinued due to protracted enrolment exacerbated by Covid-19 pandemic situation and not due to any safety issues from administration of sarilumab.
    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.

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