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    Clinical Trial Results:
    A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2019-000660-25
    Trial protocol
    		 PL  
    Global end of trial date
    23 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Nov 2021
    First version publication date
    17 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CT-P17_3.2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04171414
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CELLTRION, Inc.
    Sponsor organisation address
    23, Academy-ro, Yeonsu-gu/Incheon Metropolitan City, Korea, Republic of,
    Public contact
    MinJi Ma, Celltrion, '+82 328505780, minji.ma@celltrion.com
    Scientific contact
    SungHyun Kim, Celltrion, '+82 328504100, sunghyun.kim@celltrion.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
    23 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate usability of CT-P17 auto-injector (AI) assessed by patients at Week 4.
    Protection of trial subjects
    Hypersensitivity/allergic reactions will be assessed prior to the study drug administration and 1 hour (±10 minutes) after the end of the study drug administration by additional vital sign measurements including BP, heart and respiratory rates, and body temperature. In addition, hypersensitivity will be monitored by routine continuous clinical monitoring including patient-reported signs and symptoms. In case of hypersensitivity, emergency medication and equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial ventilation must be available and any types of ECG can be performed. For patients who experience or develop life threatening treatment-related anaphylactic reactions, study drug must be stopped immediately and the patient withdrawn from the study.
    Background therapy
    		 Methotrexate was co-administered by oral or parenteral at a dose of between 12.5 to 25 mg/week, or 10 mg/week if intolerant to a higher dose, throughout the study. Folic acid was co-administered at a dosage of at least 5 mg/week by oral dose throughout the duration of study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Aug 2019
    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
    Poland: 62
    Worldwide total number of subjects
    62
    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)
    56
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient first visit: 13 August 2019. This study was conducted at 5 study centers in Poland.

    Pre-assignment
    Screening details
    		 Male or female patients with moderate to severe active RA diagnosed according to the 2010 ACR/EULAR classification criteria, despite ongoing treatment with MTX over at least 12 weeks.

    Pre-assignment period milestones
    Number of subjects started
    		 73 [1]
    Number of subjects completed
    		 62

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Inclusion/exclusion criteria not met: 8
    Reason: Number of subjects
    		 Consent withdrawn by subject: 3
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The subject number is correct who has started screening activities.
    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 CT-P17
    Arm description
    		 CT-P17 (Adalimumab) EOW from Week 0 to Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P17
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Solution for injection
    Dosage and administration details
    40mg EOW, co-administered with MTX; 12.5–25 mg/week or 10 mg/week if intolerant to a higher dose and folic acid (≥5 mg/week).

    Number of subjects in period 1
    		CT-P17
    Started
    62
    Completed
    60
    Not completed
    2
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P17
    Reporting group description
    		 CT-P17 (Adalimumab) EOW from Week 0 to Week 24.

    Reporting group values
    		 CT-P17 Total
    Number of subjects
    		 62 62
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 56 56
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 42 42
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    CT-P17
    Reporting group description
    		 CT-P17 (Adalimumab) EOW from Week 0 to Week 24.

    Primary: The usability as assessed by patients rating using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4

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    End point title
    		 The usability as assessed by patients rating using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 4
    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: Summarized using descriptive statistics
    End point values
    		 CT-P17
    Number of subjects analysed
    62
    Units: Domain Score
    arithmetic mean (standard deviation)
        Feelings about self-injections (PRE)
    8.00 ( 2.131 )
        Feelings about self-injections (POST)
    8.16 ( 2.036 )
        Self-confidence (PRE)
    6.55 ( 1.859 )
        Self-confidence (POST)
    7.07 ( 1.616 )
        Self-image (POST)
    8.39 ( 2.079 )
        Pain and skin reactions during or after the inject
    9.59 ( 0.968 )
        Ease of use of the self-injection device (POST)
    8.70 ( 1.457 )
        Satisfaction with self-injection (PRE)
    8.27 ( 1.669 )
        Satisfaction with self-injection (POST)
    8.23 ( 1.191 )
    No statistical analyses for this end point

    Secondary: Patient’s rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24

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    End point title
    		 Patient’s rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
    End point description
    Here result from week 24 was uploaded
    End point type
    Secondary
    End point timeframe
    Weeks 0,2,24
    End point values
    		 CT-P17
    Number of subjects analysed
    60
    Units: Domain Score
    arithmetic mean (standard deviation)
        Feelings about self-injections (PRE)
    8.88 ( 2.034 )
        Feelings about self-injections (POST)
    8.97 ( 1.888 )
        Self-confidence (PRE)
    7.21 ( 1.556 )
        Self-confidence (POST)
    7.44 ( 1.840 )
        Self-image (POST)
    9.04 ( 1.533 )
        Pain and skin reactions during or after the inject
    9.60 ( 0.841 )
        Ease of use of the self-injection device (POST)
    9.35 ( 1.057 )
        Satisfaction with self-injection (PRE)
    8.83 ( 1.868 )
        Satisfaction with self-injection (POST)
    8.95 ( 1.023 )
    No statistical analyses for this end point

    Secondary: Observer’s rating of successful self-injection using self-injection assessment checklist at Weeks 0, 2, 4, and 24

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    End point title
    		 Observer’s rating of successful self-injection using self-injection assessment checklist at Weeks 0, 2, 4, and 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0,2,4,24
    End point values
    		 CT-P17
    Number of subjects analysed
    62
    Units: count of participants
        Week 0, Successful Self-Injection
    62
        Week 0, Overall Successful Self-Injection
    62
        Week 2, Successful Self-Injection
    62
        Week 2, Overall Successful Self-Injection
    62
        Week 4, Successful Self-Injection
    62
        Week 4, Overall Successful Self-Injection
    62
        Week 24, Successful Self-Injection
    60
        Week 24, Overall Successful Self-Injection
    60
    No statistical analyses for this end point

    Secondary: Mean for actual values and change from baseline in DAS28 (CRP and ESR)

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    End point title
    		 Mean for actual values and change from baseline in DAS28 (CRP and ESR)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8,16,24
    End point values
    		 CT-P17
    Number of subjects analysed
    62
    Units: score
    arithmetic mean (standard deviation)
        CRP, Baseline
    5.248 ( 0.8415 )
        CRP, Week 8, Change from baseline
    -2.560 ( 1.1223 )
        CRP, Week 16, Change from baseline
    -2.795 ( 1.2381 )
        CRP, Week 24, Change from baseline
    -3.111 ( 1.1109 )
        ESR, Baseline
    6.190 ( 0.7360 )
        ESR, Week 8, Change from baseline
    -3.287 ( 1.3525 )
        ESR, Week 16, Change from baseline
    -3.495 ( 1.4695 )
        ESR, Week 24, Change from baseline
    -3.799 ( 1.4287 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date the patient signed the ICF until EOS/ED visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    CT-P17
    Reporting group description
    		 -

    Serious adverse events
    		 CT-P17
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 62 (4.84%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Gastrointestinal disorders
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Reproductive system and breast disorders
    Cervical polyp
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Tooth infection
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 CT-P17
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 62 (48.39%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences all number
    2
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences all number
    2
    Injection site reaction
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences all number
    2
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences all number
    4
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 62 (20.97%)
         occurrences all number
    13
    Urinary tract infection
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    2 / 62 (3.23%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Nov 2019
    Summary of significant changes included the following: - Changed number of planned study population - Included anaphylactic reactions as AESI. - Differentiated the definition from the Safety Population. - Deleted time limitation regarding report of all AEs related to hypersensitivity and allergic reactions - Updated details regarding IGRA and active TB

    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.
    During the latter half of the study period, the COVID-19 pandemic broke out. For the majority of patients, only EOS visit was affected, the adjusted procedure including remote follow-up was conducted.
    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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