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    Clinical Trial Results:
    An Open-Label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis

    Summary
    EudraCT number
    2013-002790-22
    Trial protocol
    HU   CZ   EE  
    Global end of trial date
    26 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jun 2016
    First version publication date
    09 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC13752
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02121210
    WHO universal trial number (UTN)
    U1111-1143-4344
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    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
    01 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of sarilumab administered as monotherapy from baseline to Week 24.
    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
    03 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    Estonia: 13
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Chile: 8
    Country: Number of subjects enrolled
    Russian Federation: 24
    Country: Number of subjects enrolled
    United States: 38
    Worldwide total number of subjects
    132
    EEA total number of subjects
    62
    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)
    105
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 27 centres in 7 countries. A total of 201 subjects were screened between 03 June 2014 and 20 October 2014.

    Pre-assignment
    Screening details
    Of 201 subjects, 69 subjects were screen failures due to exclusion criteria met and inclusion criteria not met. 132 subjects were randomized in 1:1 ratio to either sarilumab 150 mg every two weeks (q2w) or sarilumab 200 mg q2w.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sarilumab 150 mg q2w
    Arm description
    Sarilumab 150 mg q2w for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Sarilumab
    Investigational medicinal product code
    SAR153191 (REGN88)
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection in the abdomen, thigh or upper arm.

    Arm title
    Sarilumab 200 mg q2w
    Arm description
    Sarilumab 200 mg q2w for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Sarilumab
    Investigational medicinal product code
    SAR153191 (REGN88)
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection in the abdomen, thigh or upper arm.

    Number of subjects in period 1
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w
    Started
    65
    67
    Completed
    58
    58
    Not completed
    7
    9
         Lack of efficacy
             2
             -
         Other than specified above
             -
             2
         Adverse Event
             5
             7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sarilumab 150 mg q2w
    Reporting group description
    Sarilumab 150 mg q2w for 24 weeks.

    Reporting group title
    Sarilumab 200 mg q2w
    Reporting group description
    Sarilumab 200 mg q2w for 24 weeks.

    Reporting group values
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w Total
    Number of subjects
    65 67 132
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.1 ± 12.7 53.6 ± 14.1 -
    Gender categorical
    Units: Subjects
        Female
    49 57 106
        Male
    16 10 26

    End points

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    End points reporting groups
    Reporting group title
    Sarilumab 150 mg q2w
    Reporting group description
    Sarilumab 150 mg q2w for 24 weeks.

    Reporting group title
    Sarilumab 200 mg q2w
    Reporting group description
    Sarilumab 200 mg q2w for 24 weeks.

    Primary: Percentage of Subjects With Incidence of Antidrug Antibodies (ADA)

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    End point title
    Percentage of Subjects With Incidence of Antidrug Antibodies (ADA) [1]
    End point description
    ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of subjects with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30. Analysis was performed on immunogenicity population included all randomized subjects who received at least one dose of sarilumab with at least one post-dose, evaluable ADA sample.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 30 [End of study (EOS)]
    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: Only descriptive statistics are provided for this endpoint.
    End point values
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w
    Number of subjects analysed
    65
    66
    Units: Percentage of subjects
    number (not applicable)
        Overall positive
    24.6
    18.2
        Persistent positive
    12.3
    6.1
        Persistent neutralizing positive
    10.8
    3
    No statistical analyses for this end point

    Secondary: Serum Sarilumab Concentration

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    End point title
    Serum Sarilumab Concentration
    End point description
    Trough concentration (Ctrough). Analysis was performed on pharmacokinetics (PK) population consisted of all randomized population actually received at least one or partial dose of IMP, with at least one post-dose, non-missing serum sarilumab concentration. Number of subjects analyzed=subjects with serum sarilumab concentration assessment at specified time-points.
    End point type
    Secondary
    End point timeframe
    Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30
    End point values
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w
    Number of subjects analysed
    54
    52
    Units: ng/mL
        arithmetic mean (standard deviation)
    7350 ± 8030
    17200 ± 15900
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events are treatment emergent adverse events that is AEs that developed/worsened during the time from the first dose of IMP to last dose of IMP + 60 days.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Sarilumab 150 mg q2w
    Reporting group description
    Sarilumab 150 mg q2w for 24 weeks.

    Reporting group title
    Sarilumab 200 mg q2w
    Reporting group description
    Sarilumab 200 mg q2w for 24 weeks.

    Serious adverse events
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 67 (2.99%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 65 (24.62%)
    23 / 67 (34.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 65 (0.00%)
    4 / 67 (5.97%)
         occurrences all number
    0
    4
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    8 / 65 (12.31%)
    11 / 67 (16.42%)
         occurrences all number
    12
    19
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    5 / 65 (7.69%)
    2 / 67 (2.99%)
         occurrences all number
    6
    3
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 65 (4.62%)
    4 / 67 (5.97%)
         occurrences all number
    5
    4
    Urinary Tract Infection
         subjects affected / exposed
    2 / 65 (3.08%)
    4 / 67 (5.97%)
         occurrences all number
    2
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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