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    Clinical Trial Results:
    A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

    Summary
    EudraCT number
    2018-001690-25
    Trial protocol
    HU   LT   BG   PL  
    Global end of trial date
    24 Apr 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jul 2021
    First version publication date
    09 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CT-P17-3.1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03789292
    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
    MoonSun Choi, Celltrion, Inc, +82 328505757, moonsun.choi@celltrion.com
    Scientific contact
    SungHyun Kim, Celltrion, Inc, +82 328505778, 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
    24 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate that CT-P17 is equivalent to Humira, in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR 20) at Week 24.
    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
    CT-P17 has been developed as a proposed biosimilar product of Humira (adalimumab), a recombinant humanized monoclonal antibody. The purpose of this study is to show that there are no clinical meaningful differences between the two products.
    Actual start date of recruitment
    26 Nov 2018
    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: 462
    Country: Number of subjects enrolled
    Bulgaria: 39
    Country: Number of subjects enrolled
    Hungary: 34
    Country: Number of subjects enrolled
    Lithuania: 9
    Country: Number of subjects enrolled
    Peru: 51
    Country: Number of subjects enrolled
    Ukraine: 53
    Worldwide total number of subjects
    648
    EEA total number of subjects
    544
    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)
    536
    From 65 to 84 years
    112
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First patient randomly assigned to treatment: 05 December 2018. The study was conducted at 52 study centers in Poland, Ukraine, Peru, Bulgaria, Hungary and Lithuania.

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

    Pre-assignment period milestones
    Number of subjects started
    800 [1]
    Number of subjects completed
    648

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Inclusion/exclusion criteria not met: 126
    Reason: Number of subjects
    Consent withdrawn by subject: 24
    Reason: Number of subjects
    Other: 2
    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 'Number of subjects reported to have started the pre-assignment period' means subjects who consented to participate in this trial through the Screening procedure. If these subjects meet Inclusion and Exclusion criteria defined by the protocol, they can be randomized which will have study drug administration. For this reason, 800 patients were screened and of these 648 patients were met Inclusion and Exclusion criteria and randomized to each arm.
    Period 1
    Period 1 title
    Treatment Period 1
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CT-P17
    Arm description
    CT-P17 (Adalimumab) every 2 weeks 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 syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40mg every 2 weeks, 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).

    Arm title
    Humira
    Arm description
    Humira (Adalimumab) every 2 weeks from Week 0 to Week 24
    Arm type
    Active comparator

    Investigational medicinal product name
    EU-approved Humira
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40mg every 2 weeks, 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 Humira
    Started
    324
    324
    Completed
    303
    305
    Not completed
    21
    19
         Protocol deviation
    1
    1
         Other
    1
    2
         Physician decision
    1
    -
         Adverse event, non-fatal
    7
    8
         Consent withdrawn by subject
    9
    8
         Lost to follow-up
    2
    -
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CT-P17 maintenance
    Arm description
    Patients who received CT-P17 during Treatment Period 1 and continued to receive CT-P17 in Treatment Period 2 (from Week 26 to Week 48).
    Arm type
    Experimental

    Investigational medicinal product name
    CT-P17
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40mg every 2 weeks, 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).

    Arm title
    Humira maintenance
    Arm description
    Patients who received Humira during Treatment Period 1 and re-randomized to Humira in Treatment Period 2 (from Week 26 to Week 48).
    Arm type
    Active comparator

    Investigational medicinal product name
    EU-approved Humira
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40mg every 2 weeks, 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).

    Arm title
    Switched to CT-P17
    Arm description
    Patients who received Humira during Treatment Period 1 and re-randomized to CT-P17 in Treatment Period 2 (from Week 26 to Week 48).
    Arm type
    Experimental

    Investigational medicinal product name
    CT-P17
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40mg every 2 weeks, 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 2
    CT-P17 maintenance Humira maintenance Switched to CT-P17
    Started
    303
    153
    152
    Completed
    287
    147
    143
    Not completed
    16
    6
    9
         Other
    3
    1
    -
         Physician decision
    1
    -
    -
         Adverse event, non-fatal
    3
    3
    6
         Consent withdrawn by subject
    9
    2
    2
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P17
    Reporting group description
    CT-P17 (Adalimumab) every 2 weeks from Week 0 to Week 24

    Reporting group title
    Humira
    Reporting group description
    Humira (Adalimumab) every 2 weeks from Week 0 to Week 24

    Reporting group values
    CT-P17 Humira Total
    Number of subjects
    324 324 648
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    269 282 551
        From 65-84 years
    55 42 97
    Age continuous
    Units: years
        median (full range (min-max))
    53.5 (18 to 75) 54.0 (19 to 75) -
    Gender categorical
    Units: Subjects
        Female
    249 265 514
        Male
    75 59 134

    End points

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    End points reporting groups
    Reporting group title
    CT-P17
    Reporting group description
    CT-P17 (Adalimumab) every 2 weeks from Week 0 to Week 24

    Reporting group title
    Humira
    Reporting group description
    Humira (Adalimumab) every 2 weeks from Week 0 to Week 24
    Reporting group title
    CT-P17 maintenance
    Reporting group description
    Patients who received CT-P17 during Treatment Period 1 and continued to receive CT-P17 in Treatment Period 2 (from Week 26 to Week 48).

    Reporting group title
    Humira maintenance
    Reporting group description
    Patients who received Humira during Treatment Period 1 and re-randomized to Humira in Treatment Period 2 (from Week 26 to Week 48).

    Reporting group title
    Switched to CT-P17
    Reporting group description
    Patients who received Humira during Treatment Period 1 and re-randomized to CT-P17 in Treatment Period 2 (from Week 26 to Week 48).

    Primary: Proportion of Patients with an ACR20 Response at Week 24

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    End point title
    Proportion of Patients with an ACR20 Response at Week 24
    End point description
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    CT-P17 Humira
    Number of subjects analysed
    324
    324
    Units: Responder
    268
    268
    Statistical analysis title
    Proportion of ACR20 responder
    Statistical analysis description
    The proportion of patients achieving clinical response (responder/non-responder) according to ACR20 criteria at Week 24 was analyzed as a primary endpoint. The analysis was conducted by the exact binomial approach using a Farrington-Manning score method (Chan and Zhang, 1999; Inverting two one-sided test), and the 95% CI for the difference in proportion between the 2 treatment groups was produced.
    Comparison groups
    CT-P17 v Humira
    Number of subjects included in analysis
    648
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [1]
    Method
    Parameter type
    Treatment difference (%) and 95% CI
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.94
         upper limit
    5.94
    Notes
    [1] - Predefined equivalence margin: -15% to 15%

    Secondary: Proportion of Patients with ACR50 and ACR70 Response at Week 24

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    End point title
    Proportion of Patients with ACR50 and ACR70 Response at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    CT-P17 Humira
    Number of subjects analysed
    324
    324
    Units: Responder
        ACR50
    195
    206
        ACR70
    132
    144
    No statistical analyses for this end point

    Secondary: Proportion of Patients with ACR20, ACR50 and ACR70 Response at Week 52

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    End point title
    Proportion of Patients with ACR20, ACR50 and ACR70 Response at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    CT-P17 maintenance Humira maintenance Switched to CT-P17
    Number of subjects analysed
    303
    153
    152
    Units: Responder
        ACR20
    244
    119
    125
        ACR50
    201
    95
    101
        ACR70
    135
    75
    72
    No statistical analyses for this end point

    Secondary: Change from Baseline in DAS28 (CRP) at Week 24

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    End point title
    Change from Baseline in DAS28 (CRP) at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    CT-P17 Humira
    Number of subjects analysed
    324
    324
    Units: Score
        arithmetic mean (standard deviation)
    -2.738 ± 1.1911
    -2.734 ± 1.2052
    No statistical analyses for this end point

    Secondary: Change from Baseline in DAS28 (CRP) at Week 52

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    End point title
    Change from Baseline in DAS28 (CRP) at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    CT-P17 maintenance Humira maintenance Switched to CT-P17
    Number of subjects analysed
    303
    153
    152
    Units: Score
        arithmetic mean (standard deviation)
    -2.945 ± 1.1273
    -3.074 ± 1.1926
    -2.983 ± 1.2529
    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 4 weeks after the last drug administration (up to 52 weeks)
    Adverse event reporting additional description
    TP1 groups: Treatment-emergent adverse events reported from Week 0 to Week 26 pre-dose TP2 groups: Treatment-emergent adverse events reported from Week 26 to Week 52
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    TP1: CT-P17
    Reporting group description
    CT-P17 (Adalimumab) every 2 weeks from Week 0 to Week 24

    Reporting group title
    TP1: Humira
    Reporting group description
    Humira (Adalimumab) every 2 weeks from Week 0 to Week 24

    Reporting group title
    TP2: CT-P17 maintenance
    Reporting group description
    Patients who received CT-P17 during Treatment Period 1 and continued to receive CT-P17 in Treatment Period 2 (from Week 26 to Week 48).

    Reporting group title
    TP2: Humira maintenance
    Reporting group description
    Patients who received Humira during Treatment Period 1 and re-randomized to Humira in Treatment Period 2 (from Week 26 to Week 48).

    Reporting group title
    TP2: Switched to CT-P17
    Reporting group description
    Patients who received Humira during Treatment Period 1 and re-randomized to CT-P17 in Treatment Period 2 (from Week 26 to Week 48).

    Serious adverse events
    TP1: CT-P17 TP1: Humira TP2: CT-P17 maintenance TP2: Humira maintenance TP2: Switched to CT-P17
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 324 (3.70%)
    19 / 324 (5.86%)
    6 / 303 (1.98%)
    3 / 152 (1.97%)
    5 / 152 (3.29%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polypectomy
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign muscle neoplasm
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    1 / 303 (0.33%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Extradural haematoma
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    1 / 303 (0.33%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    1 / 303 (0.33%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 324 (0.31%)
    1 / 324 (0.31%)
    1 / 303 (0.33%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Rheumatoid lung
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    1 / 303 (0.33%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nonalcoholic fatty liver disease
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Breast abscess
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic tonsillitis
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 324 (0.00%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 324 (0.00%)
    2 / 303 (0.66%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 324 (0.31%)
    0 / 303 (0.00%)
    0 / 152 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    TP1: CT-P17 TP1: Humira TP2: CT-P17 maintenance TP2: Humira maintenance TP2: Switched to CT-P17
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    96 / 324 (29.63%)
    118 / 324 (36.42%)
    50 / 303 (16.50%)
    35 / 152 (23.03%)
    33 / 152 (21.71%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    11 / 324 (3.40%)
    17 / 324 (5.25%)
    8 / 303 (2.64%)
    1 / 152 (0.66%)
    7 / 152 (4.61%)
         occurrences all number
    12
    18
    10
    1
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 324 (1.23%)
    12 / 324 (3.70%)
    4 / 303 (1.32%)
    1 / 152 (0.66%)
    4 / 152 (2.63%)
         occurrences all number
    4
    13
    5
    1
    4
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    10 / 324 (3.09%)
    9 / 324 (2.78%)
    8 / 303 (2.64%)
    0 / 152 (0.00%)
    7 / 152 (4.61%)
         occurrences all number
    17
    12
    10
    0
    9
    Neutropenia
         subjects affected / exposed
    13 / 324 (4.01%)
    17 / 324 (5.25%)
    15 / 303 (4.95%)
    6 / 152 (3.95%)
    8 / 152 (5.26%)
         occurrences all number
    19
    24
    19
    7
    12
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    16 / 324 (4.94%)
    23 / 324 (7.10%)
    1 / 303 (0.33%)
    4 / 152 (2.63%)
    1 / 152 (0.66%)
         occurrences all number
    27
    73
    1
    28
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 324 (1.54%)
    3 / 324 (0.93%)
    2 / 303 (0.66%)
    3 / 152 (1.97%)
    5 / 152 (3.29%)
         occurrences all number
    5
    3
    2
    3
    5
    Infections and infestations
    Latent tuberculosis
         subjects affected / exposed
    12 / 324 (3.70%)
    15 / 324 (4.63%)
    0 / 303 (0.00%)
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences all number
    12
    15
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    17 / 324 (5.25%)
    20 / 324 (6.17%)
    6 / 303 (1.98%)
    5 / 152 (3.29%)
    3 / 152 (1.97%)
         occurrences all number
    21
    24
    7
    6
    3
    Pharyngitis
         subjects affected / exposed
    12 / 324 (3.70%)
    10 / 324 (3.09%)
    4 / 303 (1.32%)
    4 / 152 (2.63%)
    3 / 152 (1.97%)
         occurrences all number
    12
    12
    4
    4
    4
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 324 (5.56%)
    22 / 324 (6.79%)
    10 / 303 (3.30%)
    11 / 152 (7.24%)
    6 / 152 (3.95%)
         occurrences all number
    20
    24
    11
    11
    9
    Urinary tract infection
         subjects affected / exposed
    15 / 324 (4.63%)
    15 / 324 (4.63%)
    9 / 303 (2.97%)
    5 / 152 (3.29%)
    3 / 152 (1.97%)
         occurrences all number
    17
    17
    9
    6
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2018
    Summary of significant changes included the following: • Changed the number of study centers and countries. • Added usability endpoint and assessment. • Added definition of usability population. • Added site visit (at Week 6). • Added details for usability assessment and self-injection. • Clarified training from home injection to self-injection. • Other administrative changes.

    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.
    Due to the COVID-19 pandemic, some study procedures (affecting week 48 and EOS visits only) were amended as per US FDA and EMA guidance, to prioritise subject safety and data validity.
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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